A recent joint study conducted by the FDA and Duke University found that 54% of clinical investigators only complete a single study. This alarmingly high turnover rate means that pharmaceutical, medical device, and contract research organizations (CROs) need to drastically improve their relationships with investigators and sites – now.
In this SlidShare, Param Singh, director of clinical operations solutions, presents a practical approach to solving this common, yet serious, business problem. He will discuss specific scenarios and demonstrate how to address them.
Today's marketer understands the value of creating and delivering personalized experiences. Yet when it comes to the healthcare industry, digital personalization presents a few distinct challenges.
As the industry moves to a more consumer-centric model, healthcare organizations need to engage with members on an individual level. Hear how some of these organizations are forging ahead by applying and benefiting from personalization tools to drive member engagement and retention.
In our webinar, Perficient Digital and Kaiser Permanente discussed how to:
-Engage your entire membership community through a personalized and connected experience
-Drive better outcomes and improve healthcare value
-Use Adobe Experience Cloud solutions to advance goals, such as improved member onboarding and new services engagement
The 5 Most Significant Changes in Argus Safety 8.1Perficient, Inc.
Argus Safety, Oracle's flagship safety and pharmacovigilance system, has been enhanced. The new version, 8.1, is considered a major release, due to the number of new features and capabilities.
In this SlideShare, Indy Ahluwalia, Perficient’s resident Argus Safety expert, discusses five of the system’s most significant improvements, including how 8.1 differs from previous versions.
Eisai EMEA: Laying the foundation for centralised medical information managem...Veeva Systems
Veeva Vault MedComms Customer Eisai EMEA
Elizabeth Rance, head of EMEA medical information, and David Robertson, EMEA business solutions director from Eisai discussed the following:
-An overview of Eisai’s journey so far to centralize medical information
-The initial feedback from their transformation project and longer-term objectives
-The benefits from instant visibility of metrics
Apellis Pharmaceuticals Selects a Modern Safety SolutionVeeva Systems
Apellis Pharmaceuticals shares evaluation criteria for a pharmacovigilance system and why they chose a modern safety solution. Watch the on-demand webinar to learn more: http://bit.ly/374MdP8
If your organization is using Siebel CTMS, you're already ahead of the game. However, you can further enhance the user experience and functionality by utilizing existing third-party APIs with Siebel CTMS. An API, also known as application programming interface, offers the ability to leverage various third-party web applications within a particular solution.
Examples of how you can enhance Siebel CTMS with APIs:
-Exchange rates
-Company Twitter feed
-Google Maps for clinical sites
-LinkedIn profiles for investigators
-Company news and stock quotes
-Google Analytics for CTMS users
Perficient’s Param Singh, director of clinical trial management solutions, discussed several APIs that you can use to boost productivity and increase employee engagement. The webinar included a live demonstration of a Google Analytics integration with Siebel CTMS.
Best Practices for Managing Regulatory Binders ElectronicallyVeeva Systems
- Industry drivers for change and benefits of eRegulatory
- Tips for choosing the right system and evaluating a vendor
- Best practices and mistakes to avoid when going electronic
Planning and Preparing for Electronic Health Recordsncofield
Implementing an Electronic Medical Records system is a daunting task for medical practices. This brief presentation can help a physician office understand all of the different facets of an EMR deployment and how the EMR will affect the entire network infrastructure of the practice.
Demystifying cloud system and validation practices for life sciencesVeeva Systems
Watch the on-demand recording here: bit.ly/GxPValidationwithCloud
Cloud-based regulated systems greatly accelerate the GxP validation process, improving IT efficiency. By performing and documenting the installation qualification (IQ) and operational qualification (OQ) procedures, modern cloud applications ease the validation burden on IT teams and speed validation process.
However, common misconceptions about the cloud prevent IT teams from taking advantage of a faster and better validation process.
During this webinar, "Demystifying Cloud Systems and Validation Best Practices for Life Sciences", we discuss this topic and with PricewaterhouseCoopers (PwC). By watching, you will learn GxP validation best practices in a cloud environment and gain insights into:
- How to evaluate various types of cloud-based quality systems
- How traditional vs. cloud validation approaches impact your business
- How to apply a tactical framework to validation
Today's marketer understands the value of creating and delivering personalized experiences. Yet when it comes to the healthcare industry, digital personalization presents a few distinct challenges.
As the industry moves to a more consumer-centric model, healthcare organizations need to engage with members on an individual level. Hear how some of these organizations are forging ahead by applying and benefiting from personalization tools to drive member engagement and retention.
In our webinar, Perficient Digital and Kaiser Permanente discussed how to:
-Engage your entire membership community through a personalized and connected experience
-Drive better outcomes and improve healthcare value
-Use Adobe Experience Cloud solutions to advance goals, such as improved member onboarding and new services engagement
The 5 Most Significant Changes in Argus Safety 8.1Perficient, Inc.
Argus Safety, Oracle's flagship safety and pharmacovigilance system, has been enhanced. The new version, 8.1, is considered a major release, due to the number of new features and capabilities.
In this SlideShare, Indy Ahluwalia, Perficient’s resident Argus Safety expert, discusses five of the system’s most significant improvements, including how 8.1 differs from previous versions.
Eisai EMEA: Laying the foundation for centralised medical information managem...Veeva Systems
Veeva Vault MedComms Customer Eisai EMEA
Elizabeth Rance, head of EMEA medical information, and David Robertson, EMEA business solutions director from Eisai discussed the following:
-An overview of Eisai’s journey so far to centralize medical information
-The initial feedback from their transformation project and longer-term objectives
-The benefits from instant visibility of metrics
Apellis Pharmaceuticals Selects a Modern Safety SolutionVeeva Systems
Apellis Pharmaceuticals shares evaluation criteria for a pharmacovigilance system and why they chose a modern safety solution. Watch the on-demand webinar to learn more: http://bit.ly/374MdP8
If your organization is using Siebel CTMS, you're already ahead of the game. However, you can further enhance the user experience and functionality by utilizing existing third-party APIs with Siebel CTMS. An API, also known as application programming interface, offers the ability to leverage various third-party web applications within a particular solution.
Examples of how you can enhance Siebel CTMS with APIs:
-Exchange rates
-Company Twitter feed
-Google Maps for clinical sites
-LinkedIn profiles for investigators
-Company news and stock quotes
-Google Analytics for CTMS users
Perficient’s Param Singh, director of clinical trial management solutions, discussed several APIs that you can use to boost productivity and increase employee engagement. The webinar included a live demonstration of a Google Analytics integration with Siebel CTMS.
Best Practices for Managing Regulatory Binders ElectronicallyVeeva Systems
- Industry drivers for change and benefits of eRegulatory
- Tips for choosing the right system and evaluating a vendor
- Best practices and mistakes to avoid when going electronic
Planning and Preparing for Electronic Health Recordsncofield
Implementing an Electronic Medical Records system is a daunting task for medical practices. This brief presentation can help a physician office understand all of the different facets of an EMR deployment and how the EMR will affect the entire network infrastructure of the practice.
Demystifying cloud system and validation practices for life sciencesVeeva Systems
Watch the on-demand recording here: bit.ly/GxPValidationwithCloud
Cloud-based regulated systems greatly accelerate the GxP validation process, improving IT efficiency. By performing and documenting the installation qualification (IQ) and operational qualification (OQ) procedures, modern cloud applications ease the validation burden on IT teams and speed validation process.
However, common misconceptions about the cloud prevent IT teams from taking advantage of a faster and better validation process.
During this webinar, "Demystifying Cloud Systems and Validation Best Practices for Life Sciences", we discuss this topic and with PricewaterhouseCoopers (PwC). By watching, you will learn GxP validation best practices in a cloud environment and gain insights into:
- How to evaluate various types of cloud-based quality systems
- How traditional vs. cloud validation approaches impact your business
- How to apply a tactical framework to validation
GSK: Preparing the Business for Study Start-up ChangeVeeva Systems
At the 2020 Veeva R&D and Quality Summit, GSK detailed their journey to transform study start-up. See their presentation slides for practical advice on gaining stakeholder alignment, issue resolution, and best practices to institute governance around a unified clinical program.
Watch on-demand: https://www.veeva.com/events/rd-summit/presentations/
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
Practical Strategies for Taking on New Studies Post COVID-19Veeva Systems
Hear expert guidance for ensuring readiness when opening your doors and making data-driven, evidence-based decisions on which studies to accept post COVID-19.
Vertex Reduces EDC Study Build Times by 50%Veeva Systems
Watch the video here: https://bit.ly/3oUi6Vg
The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less?
Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days.
This webinar covers:
* How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event
* Their #1 goal for transforming the UAT process
* Their novel recommendation for when to go live
* The technology strategy supporting their process improvements
Who Will Benefit:
* Clinical data executives
* Heads of clinical
* Heads of clinical research
Meet Your Presenters:
Vikas Gulati
Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals
Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc.
Richard Young
Vice President, Vault EDC, Veeva Systems
Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management.
Michelle Harrison
Associate Director of Clinical Data Management and Metrics, Vertex
Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Eric Burniche, MBA
To watch the full webinar:
The growing complexity of medical products and rapidly changing global regulations require a more holistic and consistent approach to postmarket surveillance (PMS).
However, disconnected and highly-customized solutions - historically serving med-tech companies - have fallen short of meeting the evolving needs of the industry.
Can your PMS system quickly adapt to regulatory changes and enable you to meet global submission timelines?
In this webinar, Carl Ning, Sr Director of Strategy at Veeva systems, discusses recent trends driving organizations to transform systems and processes for better product quality and reliability. You will also hear about Veeva Vault Product Surveillance, Veeva’s new application that simplifies and standardizes global postmarket surveillance.
Attend the webinar to learn:
- How to address common challenges in managing complaints and submissions
- How a unified approach to postmarket surveillance streamlines end-to-end quality management
- How Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities
Medgate Occupational Health and Safety Software - OverviewMedgate Inc.
Medgate is the global leader in occupational health and safety software. This presentation introduces the viewer to the Medgate company and provides an overview of our occupational health and safety software products.
Transforming Pharmacovigilance from Operational to Scientifically DrivenVeeva Systems
Learn how scientifically driven pharmacovigilance can enable safety teams to provide faster, more comprehensive benefit-risk assessment to improve patient’s lives. Watch the on-demand webinar: https://go.veeva.com/transforming-pv
Webinar: Driving Operational Agility with Digital Quality ManagementVeeva Systems
Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar
This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma.
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
- About the opportunities to transform quality management
- How the right technology streamlines global quality processes, increasing automation and operational agility
- The industry best practices for driving successful digital transformation
Alkermes: Improving TMF Quality and Oversight with Effective CollaborationVeeva Systems
Slides from Alkermes' 2019 Veeva R&D Summit presentation.
Implementing a team-based approach has enabled Alkermes to enhance the quality and oversight of their TMF. They'll detail how they improved trial execution and collaboration internally and across multiple CROs through active TMF management and oversight.
Immunomedics: Transforming TMF OperationsVeeva Systems
Immunomedics discusses how they achieved best-in-class TMF management and outlines steps for improving cross-functional ownership and collaboration with CRO partners.
To learn more best practices and see how organizations like Allakos, Daiichi Sankyo, and GBT maintain inspection readiness, visit this resources page: https://bit.ly/Inspection-Readiness
How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDCVeeva Systems
Watch the video here: https://bit.ly/3urhVSi
CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management. They’ll share insights into how to:
* Build a database from standards and your protocol (not a spec)
* Replace manual documentation with system-generated reports
* Provide real-time visibility into the status of data collection and cleaning
Hear their first-hand accounts of adopting an Agile Design methodology with Veeva Vault CDMS and reaping the rewards of a straightforward build and a modern EDC.
Site Connect — The Next Big Step Toward a Collaborative Clinical EcosystemVeeva Systems
Automating information exchange in clinical trials is key to improving how sponsors, CROs, and sites work together. This webinar shares how Veeva Vault Site Connect seamlessly connects sponsor and site operations for better collaboration and faster study execution.
Hear this webinar on-demand: https://go.veeva.com/collaborative-clinical-ecosystem
Yonix presents: Building the world's most sophisticated tb eradication softw...yonix
Building the world's most sophisticated TB eradication software solution.
In 2009 the Animal Health Board (AHB), who are responsible for managing New Zealand's bovine tuberculosis (bovine TB) programme, arguably completed one of the most successful software development projects in New Zealand.
The project was a great success story, delivered on time, within budget and was functionally fit for its purpose. The project took top honours at the 2008 Computerworld Awards for Excellence, winning both the Overall Excellence in the Use of ICT award and the Innovative Use of ICT award.
What distinguished this project from the typical software development project? And what role did the business analysts play in determining the success of this project?
Learning Outcomes:
• Factors critical to the success of software development projects
• How to achieve excellence in requirements and analysis
• Using business analysis to create success of software development projects
Validation strategies for cloud-based EDCs: more innovation, less effortVeeva Systems
Watch the video here: https://bit.ly/2SxsAxO
Validation concerns can hold companies back from adopting innovations in their clinical systems
Validation concerns can hold companies back from adopting the latest innovations in their EDC systems. Differing opinions on the appropriate level of system validation can also add stress within an organization. It is possible to implement new features and stay validated with relatively little effort if you use validation techniques tailored to cloud-based systems.
In this session, we address how to set the right approach, what to expect from a cloud EDC software provider and what you should expect to do as a sponsor or CRO to perform the initial validation and maintain a validated state following subsequent releases.
Who Will Benefit:
* Clinical Data Manager
* Clinical Data Director
* Head of Clinical Data
* Clinical Operations Manager
* Clinical Operations Director
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
Meet Your Presenters:
Natalie Townsend
Senior Solution Consultant, Vault CDMS
As Senior Solution Consultant for Vault CDMS Natalie is responsible for understanding customer challenges and objectives and providing technical product demonstrations tailored to address these needs. Natalie has 16+ years industry experience in designing, implementing and supporting eClinical solutions to address the myriad of challenges faced across biopharmaceutical organizations. Her experience with clinical trials spans a broad range of sponsors and therapeutic areas across all phases and regions, allowing her to appreciate the differing technology considerations and needs.
Tanya du Plessis
Vice President of data strategies and solutions, Bioforum the Data Masters
Tanya is Vice President of data strategies and solutions at Bioforum. She has vast experience across the industry through her current role at Bioforum, as well as the 14 years she spent with IQVIA (legacy Quintiles). Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups. She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data. A certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State in South Africa. She also has a project management professional certification (PMP, PMI).
Veeva Systems Webinar: Driving Continuous Quality ImprovementsVeeva Systems
Watch the on-demand webinar here: https://go.veeva.com/driving-continuous-quality-improvements/on-demand
Building a strong foundation to drive continuous quality improvements requires connecting people, processes, and technology. Life sciences companies transforming quality management with this holistic approach have increased quality management efficiency by up to 50% and reduced paperwork by 90%.
Watch the webinar and learn how you can create such a foundation for your organization on an intelligent, data-driven, end-to-end digital platform. You will also hear real-world use cases of applying advanced technologies like AI to enable proactive quality management across all operational areas.
You will hear:
- Opportunities and recommendations to unify and streamline quality systems and processes
- Areas where modern-era technologies like cloud and AI can increase efficiency, optimize cost, and bring products to patients faster
- Real-world examples of how leading organizations are transforming quality management to drive continuous quality improvements.
Preparation is the Key to Meaningful Use SuccessIatric Systems
To help hospitals and eligible providers navigate the changing landscape of Meaningful Use, we created an educational webcast.
This session provides valuable Meaningful Use information including:
• Recent updates from CMS
• Keys to audit preparation
• How to identify and correct gaps in your Meaningful Use plan
• How to ensure IMO data terminology mapping is completed accurately and on-time
GSK: Preparing the Business for Study Start-up ChangeVeeva Systems
At the 2020 Veeva R&D and Quality Summit, GSK detailed their journey to transform study start-up. See their presentation slides for practical advice on gaining stakeholder alignment, issue resolution, and best practices to institute governance around a unified clinical program.
Watch on-demand: https://www.veeva.com/events/rd-summit/presentations/
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
Practical Strategies for Taking on New Studies Post COVID-19Veeva Systems
Hear expert guidance for ensuring readiness when opening your doors and making data-driven, evidence-based decisions on which studies to accept post COVID-19.
Vertex Reduces EDC Study Build Times by 50%Veeva Systems
Watch the video here: https://bit.ly/3oUi6Vg
The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less?
Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days.
This webinar covers:
* How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event
* Their #1 goal for transforming the UAT process
* Their novel recommendation for when to go live
* The technology strategy supporting their process improvements
Who Will Benefit:
* Clinical data executives
* Heads of clinical
* Heads of clinical research
Meet Your Presenters:
Vikas Gulati
Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals
Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc.
Richard Young
Vice President, Vault EDC, Veeva Systems
Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management.
Michelle Harrison
Associate Director of Clinical Data Management and Metrics, Vertex
Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Eric Burniche, MBA
To watch the full webinar:
The growing complexity of medical products and rapidly changing global regulations require a more holistic and consistent approach to postmarket surveillance (PMS).
However, disconnected and highly-customized solutions - historically serving med-tech companies - have fallen short of meeting the evolving needs of the industry.
Can your PMS system quickly adapt to regulatory changes and enable you to meet global submission timelines?
In this webinar, Carl Ning, Sr Director of Strategy at Veeva systems, discusses recent trends driving organizations to transform systems and processes for better product quality and reliability. You will also hear about Veeva Vault Product Surveillance, Veeva’s new application that simplifies and standardizes global postmarket surveillance.
Attend the webinar to learn:
- How to address common challenges in managing complaints and submissions
- How a unified approach to postmarket surveillance streamlines end-to-end quality management
- How Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities
Medgate Occupational Health and Safety Software - OverviewMedgate Inc.
Medgate is the global leader in occupational health and safety software. This presentation introduces the viewer to the Medgate company and provides an overview of our occupational health and safety software products.
Transforming Pharmacovigilance from Operational to Scientifically DrivenVeeva Systems
Learn how scientifically driven pharmacovigilance can enable safety teams to provide faster, more comprehensive benefit-risk assessment to improve patient’s lives. Watch the on-demand webinar: https://go.veeva.com/transforming-pv
Webinar: Driving Operational Agility with Digital Quality ManagementVeeva Systems
Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar
This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma.
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
- About the opportunities to transform quality management
- How the right technology streamlines global quality processes, increasing automation and operational agility
- The industry best practices for driving successful digital transformation
Alkermes: Improving TMF Quality and Oversight with Effective CollaborationVeeva Systems
Slides from Alkermes' 2019 Veeva R&D Summit presentation.
Implementing a team-based approach has enabled Alkermes to enhance the quality and oversight of their TMF. They'll detail how they improved trial execution and collaboration internally and across multiple CROs through active TMF management and oversight.
Immunomedics: Transforming TMF OperationsVeeva Systems
Immunomedics discusses how they achieved best-in-class TMF management and outlines steps for improving cross-functional ownership and collaboration with CRO partners.
To learn more best practices and see how organizations like Allakos, Daiichi Sankyo, and GBT maintain inspection readiness, visit this resources page: https://bit.ly/Inspection-Readiness
How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDCVeeva Systems
Watch the video here: https://bit.ly/3urhVSi
CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management. They’ll share insights into how to:
* Build a database from standards and your protocol (not a spec)
* Replace manual documentation with system-generated reports
* Provide real-time visibility into the status of data collection and cleaning
Hear their first-hand accounts of adopting an Agile Design methodology with Veeva Vault CDMS and reaping the rewards of a straightforward build and a modern EDC.
Site Connect — The Next Big Step Toward a Collaborative Clinical EcosystemVeeva Systems
Automating information exchange in clinical trials is key to improving how sponsors, CROs, and sites work together. This webinar shares how Veeva Vault Site Connect seamlessly connects sponsor and site operations for better collaboration and faster study execution.
Hear this webinar on-demand: https://go.veeva.com/collaborative-clinical-ecosystem
Yonix presents: Building the world's most sophisticated tb eradication softw...yonix
Building the world's most sophisticated TB eradication software solution.
In 2009 the Animal Health Board (AHB), who are responsible for managing New Zealand's bovine tuberculosis (bovine TB) programme, arguably completed one of the most successful software development projects in New Zealand.
The project was a great success story, delivered on time, within budget and was functionally fit for its purpose. The project took top honours at the 2008 Computerworld Awards for Excellence, winning both the Overall Excellence in the Use of ICT award and the Innovative Use of ICT award.
What distinguished this project from the typical software development project? And what role did the business analysts play in determining the success of this project?
Learning Outcomes:
• Factors critical to the success of software development projects
• How to achieve excellence in requirements and analysis
• Using business analysis to create success of software development projects
Validation strategies for cloud-based EDCs: more innovation, less effortVeeva Systems
Watch the video here: https://bit.ly/2SxsAxO
Validation concerns can hold companies back from adopting innovations in their clinical systems
Validation concerns can hold companies back from adopting the latest innovations in their EDC systems. Differing opinions on the appropriate level of system validation can also add stress within an organization. It is possible to implement new features and stay validated with relatively little effort if you use validation techniques tailored to cloud-based systems.
In this session, we address how to set the right approach, what to expect from a cloud EDC software provider and what you should expect to do as a sponsor or CRO to perform the initial validation and maintain a validated state following subsequent releases.
Who Will Benefit:
* Clinical Data Manager
* Clinical Data Director
* Head of Clinical Data
* Clinical Operations Manager
* Clinical Operations Director
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
Meet Your Presenters:
Natalie Townsend
Senior Solution Consultant, Vault CDMS
As Senior Solution Consultant for Vault CDMS Natalie is responsible for understanding customer challenges and objectives and providing technical product demonstrations tailored to address these needs. Natalie has 16+ years industry experience in designing, implementing and supporting eClinical solutions to address the myriad of challenges faced across biopharmaceutical organizations. Her experience with clinical trials spans a broad range of sponsors and therapeutic areas across all phases and regions, allowing her to appreciate the differing technology considerations and needs.
Tanya du Plessis
Vice President of data strategies and solutions, Bioforum the Data Masters
Tanya is Vice President of data strategies and solutions at Bioforum. She has vast experience across the industry through her current role at Bioforum, as well as the 14 years she spent with IQVIA (legacy Quintiles). Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups. She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data. A certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State in South Africa. She also has a project management professional certification (PMP, PMI).
Veeva Systems Webinar: Driving Continuous Quality ImprovementsVeeva Systems
Watch the on-demand webinar here: https://go.veeva.com/driving-continuous-quality-improvements/on-demand
Building a strong foundation to drive continuous quality improvements requires connecting people, processes, and technology. Life sciences companies transforming quality management with this holistic approach have increased quality management efficiency by up to 50% and reduced paperwork by 90%.
Watch the webinar and learn how you can create such a foundation for your organization on an intelligent, data-driven, end-to-end digital platform. You will also hear real-world use cases of applying advanced technologies like AI to enable proactive quality management across all operational areas.
You will hear:
- Opportunities and recommendations to unify and streamline quality systems and processes
- Areas where modern-era technologies like cloud and AI can increase efficiency, optimize cost, and bring products to patients faster
- Real-world examples of how leading organizations are transforming quality management to drive continuous quality improvements.
Preparation is the Key to Meaningful Use SuccessIatric Systems
To help hospitals and eligible providers navigate the changing landscape of Meaningful Use, we created an educational webcast.
This session provides valuable Meaningful Use information including:
• Recent updates from CMS
• Keys to audit preparation
• How to identify and correct gaps in your Meaningful Use plan
• How to ensure IMO data terminology mapping is completed accurately and on-time
Understand what patient engagement truly means, its benefits for both patients and providers, and how to increase patient engagement through marketing.
RUNNING HEAD: CAREER PORTFOLIO 1
CAREER PORTFOLIO 10
Career Portfolio
CARD 405
Lakisha Riddick
Devry University
January 28, 2017
Table of Contents
- 4 -Statement of Authenticity
- 4 -Personal Mission Statement
- 4 -Elevator Speech
- 5 -Education Background
- 5 -Resume
- 7 -Professional Development and Training
- 7 -Awards and Accomplishments
- 7 -Volunteer History
- 9 -Professional Affiliation
- 9 -Career Path
- 9 -Work Samples
- 10 -Referees
Statement of Authenticity
This is to confirm that this is the portfolio of Lakisha S. Riddick It contains information detailing my education background, work experience and skills. This document should not be copied either in full or part without prior authority from Lakisha S.Riddick.Personal Mission Statement
To secure and maintain a demanding position where I can productively apply my strengths and knowledge of the Legal field in E-Discovery, Records Management,Litigation Support, and Computer Administration.management including physician contracting, utilization review, and quality assurance systems. I would also add to my skill set and achieve my Masters in Information Securities.
Elevator Speech
Resourceful associate with more than 15 years experience. Proven expertise in data management, customer service, office administration, medical records, Legal support, and organization while working for governments and corporations. Skilled in collaborating with all members of the organization to achieve objectives. Instrumental in streamlining and improving record filing processes, enhancing productivity and implementing tactical procedure implementation, compliance training. My goal is to become a valuable corporate asset by becoming a valueable asset to any orginazation mission statement .Education Background
Devry University, Charlotte NC
Bachelor of Science Computer Information Systems/Healthcare Systems Current Enrollment –June 2017
3.00 GPAResume
Lakisha S. Riddick
11459 Abbotswood Ct Uppermarlboro, M.d 20774 (803)389-9201
To maintain a position in a productive working environment, where I can continue to apply my strong knowledge of legal support in the E-discovery field, with a position as a Programmer Technican or as a Systems Administrator. the organization.
Devry University, Charlotte, NC
· Bachelor of Science in Computer Information Systems/Helathcare Systems -June 2017
Johns Hopkins University , Baltimore MD
· Courses completed -2004
Dates 12/2015 – Present CACI/SECWashington, DC
Programmer Technician II
· Apply knowledge of computer system principles, automated data processing functions, and metadata structures to develop solutions to user requirements
· Responsible for loading data into a Reccommind Dat ...
Using Data Analytics to Find and Deter Procure to Pay FraudFraudBusters
FRN combines the high quality, authoritative anti-fraud and audit content from the leading providers, AuditNet ® LLC and White-Collar Crime 101 LLC/FraudAware.
The two entities designed FRN as the “go-to”, easy-to-use source of “how-to” fraud prevention, detection, audit and investigation templates, guidelines, policies, training programs (recorded no CPE and live with CPE) and articles from leading subject matter experts.
FRN is a continuously expanding and improving resource, offering auditors, fraud examiners, controllers, investigators and accountants a content-rich source of cutting-edge anti-fraud tools and techniques they will want to refer to again and again.
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Protecting personal data has been an important issue for many years. The EU GDPR extends the data rights of individuals, and requires organizations to develop clear policies and procedures to protect personal data, and adopt appropriate technical and organizational measures. UK organizations have had to comply with the Regulation since 25 May 2018, or potentially face fines of up to 4% of annual turnover or €20 million – whichever is greater.
Learning Outcomes:
This 10 webinar series is intended to elicit a clear understanding of the core elements of the GDPR, with the ability to gain a deeper understanding by asking the trainer questions during the training.
It covers how each aspect of the Regulation can be translated into implementation actions in your organization and the auditor’s role.
Webinar 4
• How to perform a data protection impact assessment (DPIA)
• The role of the data protection officer (DPO)
• Transferring personal data outside the EU
Using Key Word Analysis of an Organization’s Big Data for Error and Fraud Detection Webinar Introduction Slides for the December 3, 2014 event including the link to register
Exploring the Cost of Developing a Financial Literacy SoftwareNdimensionLabs1
Enter financial literacy and money management software, which is designed to educate, engage, and empower users as they navigate their financial journey. Zogo, a groundbreaking software noted for its gamified approach to financial education, is one such prominent platform in this industry.
IT Fraud Series: IT Fraud and Countermeasures - July 20, 2017
Description
Webinar Series Overview: In today’s world, fraud investigations have become an everyday part of corporate life and the auditor must gain expertise in this area.
The 8 part series will cover the tasks of the fraud auditor, Forensic techniques and tools and the abilities required of the fraud auditor, the type and nature of common frauds, investigating fraud, computer fraud and control, white collar crime, the auditor in court.
This session IT Fraud and Countermeasures
• Investigating by computer
• Document collection and analysis
• Interviewing skills
• Documenting evidence
• Testifying as a witness
Similar to Keeping Clinical Investigators Happy, Productive, and Loyal (20)
The world is quite a different place than it was six months ago, and with the 2020 holiday season fast approaching, the pressure is on to meet revenue goals in what’s been an uncertain year.
In August, we surveyed 154 marketing executives to find out what they think is likely to happen this holiday season and how they are preparing for it. The results are fascinating, and we’ve distilled them into clear actions you can take right now to adapt and prepare for a very different 2020 holiday season.
In this webinar, Eric Enge (Principal, Digital Marketing at Perficient) and Jim Hertzfeld (Chief Strategist, Digital at Perficient) discussed:
How marketers have already adapted and where they see the most opportunity moving forward
What will be different this holiday season and how to adjust your strategy accordingly
Ways to identify and meet changing customer expectations, wants, and needs
How to determine if your priorities or investments should change
What actions you can take right now to be successful
Transforming Pharmacovigilance Workflows with AI & Automation Perficient, Inc.
Medical information call centers have an opportunity to transform the way they capture, code, and analyze adverse events (AEs) and product quality complaints (PQCs) with artificial intelligence (AI) and automation.
The use of such innovative technology improves data quality and consistency, compliance, and operational efficiency. It helps reduce the frequency of your pharmacovigilance (PV) operations resources going home, saying, “I have more to do at the end of the day than I did when I started."
Our one-hour, on-demand webinar shows you how you can use AI and automation to turbo-charge your end-to-end PV system. Use cases and demonstrations will include:
Analyzing safety data
Auto-coding verbatim terms to official medical dictionary terms
Auto-creating an AE case in your database
Converting speech to text
The Secret to Acquiring and Retaining Customers in Financial ServicesPerficient, Inc.
Data, when leveraged effectively, can help you segment and target customers, analyze spending habits, and can create a personalized experience that builds value and customer loyalty.
Without a 360-degree view of your customers, you can’t properly target them with real-time personalized offers, advice, and other services. In addition, lack of customer intelligence creates lost opportunities for banks and insurers to cross-sell and upsell new products and services.
Our one-hour webinar covered how customer intelligence platforms can help you engage, acquire, and retain customers.
Oracle Strategic Modeling Live: Defined. Discussed. Demonstrated.Perficient, Inc.
The only thing certain about forecasting in a volatile economy is that the future is unpredictable. Historically, organizations have effectively utilized statistical techniques for short-term business planning, but leveraging actuals no longer allows us to predict the future. The ability to be prepared, responsive, and agile under these conditions is becoming a crucial success factor. Oracle Strategic Modeling can help you better navigate change to cope with uncertainty.
If your CFO’s questions regarding earnings, liquidity, and cash flow are unceasing and far-reaching, watch our on-demand webinar for a deep dive into strategic modeling. We modeled real-world scenarios to show how you can:
Quickly and easily develop a hierarchical model of your business
Leverage multiple pre-built functions to forecast key performance drivers
Provide transparency on forecasted financials via audit trail
Utilize goal seek to set financial targets and estimate the financials drivers necessary to achieve it
Perform sophisticated “what-if” analysis via simulations to improve the accuracy of your forecast
Use built-in dashboard functionality to deliver powerful reporting capabilities
While many stay-at-home orders have been lifted, consumers’ new digital buying behaviors and habits are here to stay. Watch our panel discussion on the accelerated need for commerce and learn how commerce and content can transform our digital economy.
Topics include:
-What is the “experience economy” and how do you leverage it? -If you move beyond product and price, what’s next?
-How business models have shifted and what you can do to break down silos and leverage new processes to capture the digital dollar.
-How organizations have built agile teams to address the ever-changing needs of customers, including responsive approaches that address the omnichannel consumer.
-Technologies that are best suited to enable your business and customers – and how headless commerce has changed the game.
-How the future of commerce is changing, and what you should do now to prepare.
Our panel features Jordan Jewell, IDC Research analyst known for his insight into the commerce industry. Joining him from Perficient is general manager Brian Beckham, who brings deep expertise in content management and empowering organizations in their digital transformations. Rounding out the panel is Episerver’s Joey Moore, who has spent the last decade helping organizations across the globe advance their digital maturity.
Centene's Financial Transformation Journey: A OneStream Success StoryPerficient, Inc.
Centene, a large multi-line managed care organization, was looking to modernize and streamline its corporate performance management (CPM) applications.
Centene had to move data between platforms multiple times during the close process so that close data could be fully consolidated and made available for reporting. This process had numerous challenges and inefficiencies that Centene wished to improve upon so that they could provide a more streamlined and more transparent process to the functional teams that leverage consolidated financials in their systems for reporting and analysis.
Centene chose OneStream XF for global and US consolidations, currency conversion, eliminations, and ownership percentage.
Michael Vannoni, director, financial systems solutions discussed the migration to OneStream XF including:
-Factors leading to the selection of OneStream XF
-Details of the solution design
-Benefits realized with global consolidation implementation
-Future planned enhancements
WHODrug Koda, developed by Uppsala Monitoring Centre (UMC), is an automated coding service, which uses artificial intelligence (AI) to automate the coding of drug names and ATC selections, improving consistency and operational efficiency. It can also be used to accelerate dictionary upgrades, including the transition from WHODrug B2 format to B3.
Through API (Application Programming Interface) web services, the coding engine can be integrated with custom or off-the-shelf drug safety, medical coding, or data management systems.
In this webinar, Perficient and UMC discussed WHODrug Koda and how you can integrate it into your medical coding activities.
Preparing for Your Oracle, Medidata, and Veeva CTMS Migration ProjectPerficient, Inc.
There are multiple reasons why companies migrate to a new clinical trial management system (CTMS). Still, the two most common are mergers and acquisitions (i.e., CTMS consolidation) and the desire to switch CTMS vendors. Regardless of the reason, many of the best practices, processes, and tools are the same.
In this webinar, we looked at the migration approaches taken across several case studies. You’ll come away with an understanding of:
Pros and cons of each CTMS migration method
Types of migration tools, including APIs, ETL tools, and adapters
Approximate timelines and costs associated with each migration method
The topics discussed in this webinar can be applied to any CTMS migration project, whether you’re moving to or from Oracle’s Siebel CTMS, Medidata’s Rave CTMS, and Veeva’s Vault CTMS.
Accelerating Partner Management: How Manufacturers Can Navigate Covid-19Perficient, Inc.
The pandemic has ushered in a new normal for manufacturers, and the impact of digital communication is more important than ever.
View our on-demand webinar with Tony Kratovil, Regional Vice President of Manufacturing at Salesforce, and Eric Dukart, National Sales Executive at Perficient. They covered why the right digital strategies are critical for manufacturers in the wake of COVID-19.
Our webinar covered:
Current challenges with forecasting, collaboration, and disruptions to distribution networks.
Insights for stabilizing operations, accelerating partner management, and developing a digital strategy that differentiates your business.
Candid Q&A with real-world examples.
New Work.com resources to help manufacturers restart safely and rebuild.
Tools and resources to move forward – fast.
The Critical Role of Audience Intelligence with Eric Enge and Rand FishkinPerficient, Inc.
Things move quickly in marketing. How do you identify what your customers need and how you can help? Now more than ever, audience intelligence is the key.
Audience intelligence is about understanding your target customers, their needs, what resonates with them, and how you can reach them. Eric Enge (Digital Marketing Principal, Perficient) and Rand Fishkin (Co-Founder & CEO, SparkToro) discussed this topic live on May 7, 2020. Watch to hear tactics for gaining a better understanding of your customers, how to use audience intelligence to optimize your marketing now, and more.
Cardtronics, the global leader in ATM deployment and management, decided to retire its on-premises Hyperion solution to gain the operational efficiencies, features, and functionality provided by a best-in-class cloud solution.
Cardtronics chose Oracle EPM Cloud including Financial Consolidation and Close, Planning, Management Reporting, Account Reconciliation, Enterprise Data Management, as well as Oracle Analytics Cloud.
In this video, project owner Richard Ng, director, financial systems, Cardtronics, discusses the migration to Oracle EPM Cloud including:
Multi-release 18-month deployment schedule across multiple countries
Benefits of a global Chart of Accounts for ERP and EPM
Seamless integration across ERP Cloud, HCM Cloud, and EPM Cloud
Preparing for Project Cortex and the Future of Knowledge ManagementPerficient, Inc.
Microsoft has turned traditional enterprise content management on its head with its recent announcement of Project Cortex.
Project Cortex uses advanced artificial intelligence to harness collective knowledge from across the enterprise and automatically organize it into shared topics like projects, products, processes, and customers. Using AI, Cortex creates a knowledge network based on relationships among topics, content, and people and delivers it in the apps you use every day – Office, Outlook, and Teams.
This webinar examined Project Cortex in more detail, including:
• What is Project Cortex?
• Why is Project Cortex different than other knowledge network projects previously introduced?
• How does incorporating AI and automation change the game?
• What is possible with Project Cortex?
• What can you do to prepare?
Utilizing Microsoft 365 Security for Remote Work Perficient, Inc.
With an increasingly mobile workforce, and the spread of shadow IT, the rapid rise of cybercrime - companies must find unique ways to effectively manage their sprawling SaaS portfolio.
Slack (or Teams) Automation for Bonterra Impact Management (fka Social Soluti...Jeffrey Haguewood
Sidekick Solutions uses Bonterra Impact Management (fka Social Solutions Apricot) and automation solutions to integrate data for business workflows.
We believe integration and automation are essential to user experience and the promise of efficient work through technology. Automation is the critical ingredient to realizing that full vision. We develop integration products and services for Bonterra Case Management software to support the deployment of automations for a variety of use cases.
This video focuses on the notifications, alerts, and approval requests using Slack for Bonterra Impact Management. The solutions covered in this webinar can also be deployed for Microsoft Teams.
Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
Software Delivery At the Speed of AI: Inflectra Invests In AI-Powered QualityInflectra
In this insightful webinar, Inflectra explores how artificial intelligence (AI) is transforming software development and testing. Discover how AI-powered tools are revolutionizing every stage of the software development lifecycle (SDLC), from design and prototyping to testing, deployment, and monitoring.
Learn about:
• The Future of Testing: How AI is shifting testing towards verification, analysis, and higher-level skills, while reducing repetitive tasks.
• Test Automation: How AI-powered test case generation, optimization, and self-healing tests are making testing more efficient and effective.
• Visual Testing: Explore the emerging capabilities of AI in visual testing and how it's set to revolutionize UI verification.
• Inflectra's AI Solutions: See demonstrations of Inflectra's cutting-edge AI tools like the ChatGPT plugin and Azure Open AI platform, designed to streamline your testing process.
Whether you're a developer, tester, or QA professional, this webinar will give you valuable insights into how AI is shaping the future of software delivery.
Essentials of Automations: Optimizing FME Workflows with ParametersSafe Software
Are you looking to streamline your workflows and boost your projects’ efficiency? Do you find yourself searching for ways to add flexibility and control over your FME workflows? If so, you’re in the right place.
Join us for an insightful dive into the world of FME parameters, a critical element in optimizing workflow efficiency. This webinar marks the beginning of our three-part “Essentials of Automation” series. This first webinar is designed to equip you with the knowledge and skills to utilize parameters effectively: enhancing the flexibility, maintainability, and user control of your FME projects.
Here’s what you’ll gain:
- Essentials of FME Parameters: Understand the pivotal role of parameters, including Reader/Writer, Transformer, User, and FME Flow categories. Discover how they are the key to unlocking automation and optimization within your workflows.
- Practical Applications in FME Form: Delve into key user parameter types including choice, connections, and file URLs. Allow users to control how a workflow runs, making your workflows more reusable. Learn to import values and deliver the best user experience for your workflows while enhancing accuracy.
- Optimization Strategies in FME Flow: Explore the creation and strategic deployment of parameters in FME Flow, including the use of deployment and geometry parameters, to maximize workflow efficiency.
- Pro Tips for Success: Gain insights on parameterizing connections and leveraging new features like Conditional Visibility for clarity and simplicity.
We’ll wrap up with a glimpse into future webinars, followed by a Q&A session to address your specific questions surrounding this topic.
Don’t miss this opportunity to elevate your FME expertise and drive your projects to new heights of efficiency.
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Securing your Kubernetes cluster_ a step-by-step guide to success !KatiaHIMEUR1
Today, after several years of existence, an extremely active community and an ultra-dynamic ecosystem, Kubernetes has established itself as the de facto standard in container orchestration. Thanks to a wide range of managed services, it has never been so easy to set up a ready-to-use Kubernetes cluster.
However, this ease of use means that the subject of security in Kubernetes is often left for later, or even neglected. This exposes companies to significant risks.
In this talk, I'll show you step-by-step how to secure your Kubernetes cluster for greater peace of mind and reliability.
Smart TV Buyer Insights Survey 2024 by 91mobiles.pdf91mobiles
91mobiles recently conducted a Smart TV Buyer Insights Survey in which we asked over 3,000 respondents about the TV they own, aspects they look at on a new TV, and their TV buying preferences.
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
2. 2
About Perficient
Perficient is the leading digital transformation
consulting firm serving Global 2000 and enterprise
customers throughout North America.
With unparalleled information technology, management consulting,
and creative capabilities, Perficient and its Perficient Digital agency
deliver vision, execution, and value with outstanding digital
experience, business optimization, and industry solutions.
3. 3
Perficient Profile
Founded in 1997
Public, NASDAQ: PRFT
2016 revenue $487 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chicago,
Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax,
Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis,
New York City, Northern California, Oxford (UK), Southern
California, St. Louis, Toronto
Global delivery centers in China and India
~3,000 colleagues
Dedicated solution practices
~95% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards
5. 5
Today’s Presenter
Param Singh
• Director, Life Sciences
• Leads clinical operations and
connected health initiatives
• 9 years with Perficient
• 15 years in life sciences
5
6. 6
• Why prioritize the investigator relationship?
• Countdown of 7 relationship strains, along with
examples of effective solutions
• Where to go from here
• Links to additional resources
Agenda
7. 54.2% of
investigators
complete just
one study
Source: One and done: Reasons principal investigators
conduct only one FDA-regulated drug trial. Contemporary
Clinical Trial Communications, Volume 6, June 2017,
Pages 31-38.
8. 8
#7 Cumbersome Site-monitoring Visits
ISSUES
• Site monitoring is both important and burdensome
• Monitors struggle with:
• Scheduling visits
• Accessing what they need during visits
• Completing reports and routing them for
review and approval
• Ensuring sites address outstanding issues
• Sites struggle with TIME: prep, hosting, and
addressing issues
GUIDANCE
• Adopt a risk-based monitoring (RBM) approach
• Automate prep and follow-up notifications
• Provide monitors with convenient tools that facilitate
the process
• Streamline report creation, review, and approval
• Automatically share relevant parts of approved
reports with site personnel
9. 9
#7 Cumbersome Site-monitoring VisitsSiteMonitor
SiteStaff
Member
Schedules the visit
with the site
(online or via the
mobile app)
End
Start
Receives a
notification that
one of her sites
is due for a
monitoring visit
You
Review and
approve the
monitoring report
Conducts the visit
and completes the
visit report using
the interactive
mobile app
Submits the report
for review and
approval
Receives
automatic
reminders and
preparation tips
Hosts the site
monitor
Receives a
notification that
the monitoring
visit results have
been published
10. 10
#6 Ineffective Subject Screening
ISSUES
Too many screen failures
+ Too many early terminations
= Too much time and expense lost
GUIDANCE
• Provide site personnel with tools that boost their
screening effectiveness, and continually monitoring
and improving those tools over time
• Shift the burden of the screening process away from
site personnel
• Automate the data capture process during the
screening visit
11. 11
#6 Ineffective Subject Screening (Solution 1)Potential
Subject
SiteStaff
Member
Follows the interactive
prompts in the
screening mobile app
on her iPad
End
Start
Comes into site for his
screening visit
You
After noticing several
issues with a particular
screening criterion, you
initiate a protocol
amendment workflow
Once the amendment
has been approved,
you make the update
to the mobile app
Watching over time,
you see improvement
in the updated
screening criterion and
overall recruitment
Gets tripped up on a
specific screening
criterion, but makes it
through
Automatically receives
the updated version of
the mobile app
12. 12
#6 Ineffective Subject Screening (Solution 2)Potential
Subject
SiteStaff
Member
Explains the self-
screening process:
going from station to
station and interacting
with each digital device
EndStart
Comes into site for his
screening visit
Thanks the potential
subject and informs
him of next steps
Interacts with each
digital device to
complete his
self-screening tests
Investigator
Receives a notification
that a potential subject
tentatively passed
screening
Reviews screening
results and approves
subject for enrollment
Receives a welcome
notification with a
request to complete
informed consent
13. 13
#5 Clinical Data-entry Mistakes
ISSUES
Dirty clinical data:
• Slows time to market
• Increases development costs
• Stalls (or stops!) new drug applications (NDAs)
• Damages relationship with site
GUIDANCE
• Leverage digital technology and the Internet of
Things (IoT) in clinical data collection!
14. 14
#5 Clinical Data-entry Mistakes (Solution 1)ClinicalSubject
SiteStaff
Member
Issues the clinical
subject his wrist
tracker and
digital
skin patch
End
Start
Receives
automatically
transmitted
results
Downloads the
medication
adherence
mobile app on
his mobile phone
Wears his
wearables as
agreed upon
during informed
consent
Receives push
notifications via
the mobile app
to take his
medication
Receives
automatically
transmitted
results
Receives a
notification that
the subject s
blood pressure is
running high
Receives a
notification that
an appointment
is needed
Schedules his
appointment via
the mobile app
and receives
reminders
15. 15
#5 Clinical Data-entry Mistakes (Solution 2)Potential
Subject
SiteStaff
Member
Receives
notifications
when entries are
submitted
End
Start
Downloads the
patient diary
mobile app
onto his phone
You
Receive a
notification of a
potential adverse
event
Kick off your
safety signal
evaluation
process
Receives a
notification of a
potential adverse
event in one of
the entries
Receives push
reminders to log
his diary entries
Uses the
interactive
mobile app to log
his entries on
schedule
Receives
environmental
data from the
other apps on his
phone
16. 16
#4 Slow Subject Recruitment
ISSUES
• Even promising sites can struggle with
subject recruitment
• Pressure from CRO upper management or the
sponsor to meet recruitment targets stress and
anxiety for study managers strains relationships
with underperforming sites
GUIDANCE
• Broaden the site’s pool of potential subjects
• Build a database of potential subjects
• Leverage the social networks of potential subjects
for recruiting purposes
17. 17
#4 Slow Subject RecruitmentPotential
Subject
SiteStaff
Member
Receives a profile for
someone nearby who
meets the minimum
eligibility criteria for a
current study
Receives an invitation
to schedule a screening
visit at a nearby site
After failing the
screening visit, receives
an automated request
to help recruit others
via his social network
EndStart
Receives invitation to
apply to participate in
a study (website
popup, Google ad, etc.)
Creates a login, fills out
a profile, and submits
18. 18
#3 Problems with Payments
ISSUES
• Significant drain on sponsor/CRO resources
• Complex, manual investigation processes
• Slow turnaround time
• Lack of transparency with sites
• Leads to site personnel feeling frustrated,
undervalued, and distrustful
• Further leads to decline in site productivity
GUIDANCE
• Provide sites with a comprehensive history of
payments that have been issued to them
• Equip sites with self-service tools to open claims
against payments that seem incorrect
• Give sites the ability to see the status of open claims
over time
• Automate claim investigations and resolutions,
where possible and appropriate
19. 19
#3 Problems with PaymentsInvestigatorYou
Start
Views the complete
log of payments she
has received
to-date
Notices a payment
that seems
incorrect and
drills down into
the details
Perform your
investigation and
update the claim
status
Opens a claim
against the
payment
Watches the claim
status over time
End
Receives a
notification that
explains the claim
resolution
Receive notice of a
claim that was not
resolvable through
automated
workflows
Resolve the claim
and update the
claim status
20. 20
#2 Outdated Contact Details
ISSUES
Outdated site contact details can result in:
• Delayed or lost site essential documents
• Difficulty scheduling monitoring visits
• Difficulty communicating about monitoring visit
action items
• Delayed or lost clinical supplies shipments
• Delayed or lost site payments
GUIDANCE
• Empower sites to see the contact information on file
for them at all times
• Provide sites with self-service tools to update their
contact information
• Periodically prompt site personnel to verify their
contact information on file
21. 21
#2 Outdated Contact DetailsSiteStaff
Member
You
Start
Receives a
prompt to verify
that her contact
information is
correct
Reviews her
information and
notices outdated
information
Receive a
notification
of a newly
submitted
update
Review the
content of the
update
Accept the
update
Updates the
information and
submits the
update
Watches the
status of the
update over time
End
Receives a
notification that
her update was
completed
22. 22
#1 Poor Clinical Document Compliance
ISSUES
• Ongoing battle for every sponsor and CRO
• Volume of required documentation is daunting
• Rather burdensome for sites
• Can lead to audit findings against sponsors
GUIDANCE
• Provide sites with greater visibility into their
document compliance status
• Automate notifications related to upcoming and
past-due document deadlines
• Enable easier document reviews, approvals, and
sharing back and forth
23. 23
#1 Poor Clinical Document ComplianceSiteStaff
Member
You
Start
Receives a
notification that a
document on file
expires in 30 days
Receives a
notification that the
document now
expires in 14 days
Receive a
notification that the
expiring document
has been updated
Updates the
document
Logs in, finds the
document currently
on file, and uploads
the updated version
End
Sees that the site s
overall document
compliance is back
in good standing
Receive a
notification
about an expiring
site document
24. 24
Where to Go from Here
Confident some or all of these issues apply to your
organization? Let us show you the solutions in action.
Not sure about the root of the issues you have with your
sites? Partner with us to uncover the answers.
25. 25
• A Proven Methodology for Improving Clinical Site
Performance | Download
• Incorporating Digital Technology into Clinical Trials |
View On Demand
• Modernizing Clinical Trial Operations with Digital
Experience Technologies | Download
• Cultivating Patient-Pharma Relationships in the
Digital Era | View On Demand
• Life Sciences is Going Digital: 30 Examples from
Industry Leaders | Download
Additional Resources
• Perficient.com/SocialMedia
• Facebook.com/Perficient
• Twitter.com/Perficient_LS
• Blogs.perficient.com/LifeSciences
Why prioritize the investigator relationship
Countdown of 7 relationship strains, along with examples of effective solutions (presented in order of least pressing to most pressing, as voted by YOU)
Where to go from here
Links to additional resources
No time for Q&A today (30-minute format) (But I will be available via email after the webinar to answer questions)
We’ve got a lot to cover, so let’s get started!
I wanted to kick off today’s webinar with this quote from a study that came out earlier this year because it really encapsulates the urgency of the topic at hand – the relationship between sponsors or CROs and clinical investigators. When more than half of your PIs are walking away after you’ve gone through the trouble of getting their site up and running, you’ve got a really expensive problem that needs to be solved ASAP.
Well, I’ll tell you: In our nearly 20 years of working with the life sciences industry, we’ve spoken with countless pharmaceutical companies, medical device companies, and CROs about their relationships with clinical sites and investigators – many of whom are actually on today’s call. We’ve listened to their struggles and the things they’ve tried to make things better, including what’s worked and what hasn’t.
We’ve learned a lot from these organizations and, by helping them understand their sites as customers, we have been able to successfully advise and support them in designing and implementing effective solutions. Today, we’re going to share with you our insight into this unique relationship.
In today’s webinar, we’re going to highlight the seven most common issues that strain the relationship between sponsor/CRO and site/investigator, and provide guidance on proven, practical solutions for each one. We’ll go through them in countdown style, from smallest issue to biggest issue, as voted by all of YOU!
While sponsors, CROs, and clinical sites all acknowledge that site monitoring is a necessary part of ensuring clinical trials are run in compliance with governing regulations and protocols, it can be a rather burdensome process, both for monitors and for sites.
Monitors struggle with scheduling the visits, having access to everything they need during the visits, completing their reports, getting those reports reviewed and approved, and ensuring sites address any outstanding issues they identify. Sites struggle with taking the time to prepare for and host the visits, as well as to address the follow-up issues, on top of the burden of running the trial and handling their regular patient load.
These struggles – on both sides – can be reduced by:
Adopting a risk-based monitoring (RBM) approach, so that sites are only monitored when necessary
Automating preparation and follow-up notifications
Providing monitors with convenient tools that facilitate the monitoring process
Streamlining report creation, review, and approval
Automatically sharing relevant parts of approved reports with site personnel
One of the more thoughtful solutions we have seen to this issue works like this:
Based on predefined clinical data and milestones, a site monitor receives a notification that one of her sites requires a site monitoring visit. She works with the site to schedule the visit, and both she and the site receive automated confirmation emails.
The day of the visit, the monitor arrives at the site with her iPad, which contains a proprietary site monitoring mobile app. She finds that the site’s wireless internet is down for the day, so she uses the app in offline mode.
Throughout the visit, she uses the interactive, decision-tree-based user interface to address all of the topics, ask all of the questions, and record all of the answers. She even uses the iPad camera to take photos and attach them to the report.
After the visit, when she gets back online, the app syncs with the system and she is able to issue the report for review. After receiving her manager’s feedback and making the adjustments, she routes the report for approval. The app allows her and her manager to apply 21 CFR Part 11-compliant digital signatures, and also maintains a complete audit trail of the report’s review and approval history.
Once approved, the details from the report that are relevant to the site are automatically shared with the site in a read-only capacity, and follow-up emails that include action items and due dates are automatically sent to all parties.
Combining risk-based monitoring with convenient and effective digital tools can significantly improve the site monitoring experience, both for monitors and for site personnel. The ideal approach minimizes the burden on all parties without compromising the quality of the monitoring process, which this solution accomplishes beautifully. And the collaborative and transparent nature of the process inherently boosts the monitor-site relationship.
Even when sites are able to recruit a large pool of potential subjects, sponsors and CROs see far too many subjects who fail to pass the screening visit (screen failures) and subjects who pass the screening visit only to leave the study early (early terminations). Because sites get paid for every subject visit that occurs, regardless of whether the subject passes or completes the study, both of these situations are costly and lead to tension between the sponsor/CRO and the site/investigator.
This strain can be eased by:
Providing site personnel with tools that boost their screening effectiveness, and continually monitoring and improving those tools over time
Shifting the burden of the screening process away from site personnel
Automating the data capture process during the screening visit
We have seen companies tackle this issue effectively in two primary ways, both of which leverage digital technology and CX principles. Imagine the following:
A potential clinical subject comes into a site for his screening visit. The nurse performing the screening visit takes out her iPad, brings up the screening app, and follows the interactive prompts to move the potential subject through the various questions and tests.
When the nurse selects or inputs the potential subject’s answers, the app dynamically adjusts the questions that are asked, and their sequence, in a decision-tree format that is relevant to the potential subject.
When the nurse performs the tests, the data is automatically captured in the app via wireless connection with the testing device – no data entry is required.
When the screening visit is complete, the nurse submits the results, all of which are automatically transmitted to your EDC system and other clinical systems.
Additionally, stats about the nurse’s performance and her experience using the app are automatically transmitted (e.g., How long did it take her to move from step to step? How long was the overall visit? In which steps did she seem to struggle?).
As the sponsor or CRO running the study, you see the individual nurse’s performance and use data, as well as aggregate data from a single site, multiple sites, and all sites in a study. This analytical dashboard allows you to identify positive and negative trends in the screening process, as well as potential issues that need to be clarified or corrected.
Based on the data you see, you recognize that a particular question in the screening process needs clarification. You kick off a workflow to approve the change. Once approved, you make the change and release it for production use. Over time, you see the use data for that question improve.
This is a popular approach to addressing the issue because it is easily attainable and clearly impactful. At its core, this solution reframes the site personnel who perform the screening process as customers, and then uses CX principles to provide them with a convenient and engaging tool for completing the process. It also comes with two rather pleasant side effects: it greatly reduces data entry error that can lead to erroneous screen failures and screen passes, and it provides insight into how to continually improve the overall screening process.
A second approach that we see industry pioneers adopting works something like this:
A potential clinical subject comes into a site for his screening visit. When he checks in, he is issued an iPad for use during the visit. On the iPad, he finds an interactive app that leads him step-by-step through the screening process. It moves him through questions dynamically, using a decision-tree format that adjusts based on his answers.
When it comes to screening tests, the app moves him through a circuit of digital devices, each designed to perform different tests – a digital scale, a digital blood pressure machine, a digital toilet.
When the potential subject has completed all of the questions and tests, he submits his results and returns the iPad to the front desk. All of his data is automatically transmitted to the site personnel and your EDC system. The data is then automatically analyzed and issued a tentative status of “pass,” which triggers a notification to the site investigator.
Later that day, when the investigator has a moment, he reviews the potential subject’s results and approves his participation in the study. As soon as his status changes to approved, he receives a welcome notification and a request to complete the informed consent process.
While this scenario might seem overly futuristic to some, we definitely see this happening, and all signs point to this being the direction the industry is heading. This highly digitized and automated solution significantly reduces the screening burden on site personnel and significantly increases the accuracy of the data collected during the screening process. It also more closely aligns with patient/subject expectations in the “Age of the Customer,” resulting in a more pleasant and engaging experience for them.
Granted, this solution does take more effort to design and implement, but in the case of large-scale, long-term clinical trials, or of a particular site being involved in several of your trials over time, the return on investment (ROI) is clear.
Dirty clinical data is one of the most costly aspects of clinical trials. Not only does the review and cleanup slow down time to market and increase development costs, dirty data can stall or even kill a new drug application (NDA). Consistently receiving dirty data from sites can seriously damage a sponsor’s or CRO’s relationship with a site/investigator, and can lead to a site no longer working with a sponsor or CRO, even though that site might have the ideal patient population, location, equipment, and/or expertise that the sponsor or CRO needs.
This tension can be reduced by leveraging digital technology and the Internet of Things (IoT) in clinical data collection.
We are seeing companies exploring this, dabbling in it, and even diving in head-first, including this scenario:
After successfully enrolling in a clinical study, a subject is issued a wrist tracker and a digital skin patch, and is given login credentials for a proprietary app to download on his mobile phone and tablet.
Over the course of the study, his wrist tracker and skin patch continuously collect and transmit data to his managing site and your EDC system. Additionally, the mobile app pushes him reminders to take his medication.
One day, the investigator receives a notification that the subject’s blood pressure is running high, along with a prompt to ask whether he should be asked to come in for a visit. The investigator clicks “accept” and the subject receives a notification on his phone, along with the option to schedule his appointment online. He completes the scheduling process and makes his way into the site for his appointment.
One of the most beneficial (and attainable) solutions we have seen that makes use of IoT technology is for subject diaries, including reminding subjects to complete their entries, facilitating their entries in interactive and engaging ways, and automatically mining their entries for potential adverse events.
Consider this scenario:
Once successfully enrolled in your study, a clinical subject is issued login credentials for a proprietary mobile app he downloads onto his phone. Over the course of his participation in your study, he receives push notifications to remind him to log periodic diary entries. In the app, he follows interactive prompts that ensure he’s submitting his diary entries completely and on time. The app even rewards him for doing so.
His diary entries are automatically transmitted to your EDC system and other clinical systems. Additionally, the app makes use of the other functions of his phone to submit environmental data, such as exercise and sleep data. All the while, third-party contextual analysis software is monitoring his diary entries.
One day, the investigator receives a notification that the content of one of the subject’s diary entries seems like a potential adverse event, along with a prompt to ask whether he should be asked to come in for a visit. The investigator clicks “accept” and the subject receives a notification on his phone, along with the option to schedule his appointment online. He completes the scheduling process and makes his way into the site for his appointment.
The third-party contextual analysis software is an especially brilliant addition to the use of digital technology in clinical data collection. It goes above and beyond just ensuring accurate and timely data collection, and aids sites, sponsors, and CROs in the identification of potential adverse events in a way that only machine learning technologies can.
Even the most promising clinical sites can have trouble recruiting enough eligible subjects. Pressure from upper management and/or the sponsor organization to meet recruitment targets causes stress and anxiety for study managers, which in turns strains their relationships with underperforming sites.
This tension can be alleviated by helping sites:
Broaden their pool of potential subjects
Build a database of potential subjects
Leverage the social networks of potential subjects for recruiting purposes
To illustrate how companies achieve this, consider the following scenario:
While surfing the web on his mobile phone, a young man receives an offer to apply to participate in a clinical trial. He thinks, “Why not?,” creates a user ID and password, and then follows a series of interactive prompts to build out his profile. While there are no current trials that are a good fit for him, he continues to receive occasional helpful tips for managing the conditions he included in his profile.
Down the road, potentially after failing a screening visit, his profile is flagged as someone who is not himself a good fit for a new study, but as someone who might have people in his social network who are. So, he receives a request to spread the word to his network, along with ready-to-use tweets and Facebook posts. A few people in his network are interested and create their own profiles, just like their friend, and the process restarts for each of them.
This modern, multi-faceted solution not only frees sites from the constraints of their existing patient population and physical location, but makes it convenient for potential subjects to become and stay engaged over time. It casts a wider net than any one site can, involves more parties (even automated parties) in recruitment efforts, and leverages customer experience (CX) principles to connect potential subjects to sites.
This is one of the biggest complaints we hear from both sponsors/CROs and sites/investigators. Sponsors and CROs dedicate countless resources to researching and addressing payment questions and concerns raised by site personnel, and site personnel often feel frustrated, undervalued, and distrustful of sponsors and CROs that do not pay them as promised.
When a site is not paid on time, is not paid correctly, or is not acknowledged in a timely manner when payment issues are raised, it can trigger a sharp decline in site productivity, which negatively impacts a product’s overall time-to-market.
This negative outcome can be sidestepped by:
Providing sites with a comprehensive history of payments that have been issued to them
Equipping sites with self-service tools to open claims against payments that seem incorrect
Giving sites the ability to see the status of open claims over time
Automating claim investigations and resolutions, where possible and appropriate
Here is one of the more thoughtful solutions we have seen that incorporates the above principles:
An investigator running a study site logs in to see an overview of her payment history. Something seems off, so she begins to review each payment in detail, and comes across what she believes to be the source of the problem – the withholding for her first payment seems higher than what was agreed upon in the contract she signed. The percentage was corrected for all subsequent payments, but the original payment was never adjusted.
Rather than picking up the phone, right there in the system, she opens a claim against the payment in question and selects “Withholding” as the type of claim. She fills out the other required fields and submits the claim; the status changes to “Submitted.”
The field values the investigator selected trigger an automated resolution process in which the withholding percentage in the payment is compared to the details of the contract.
The automated workflow is unable to resolve the claim because the contract contains two different withholding percentages, so your clinical finance team is notified that human intervention is required. A clinical finance staff team member picks up the claim, which changes the status to “Under Review” The investigator can see that someone is working on his claim.
Your clinical finance resource works with your legal team to draft an amendment to the contract that clarifies the correct withholding percentage for the site/investigator and routes the amendment for review and approval. After receiving the approval from the investigator, clinical finance issues a payment adjustment for the initial payment; the claim status changes to “Resolved.” Once the investigator receives the payment adjustment, she clicks the “Accept Resolution” button for the claim, and the claim is closed.
While it does take time and effort to map out the automated workflows for investigating payment claims, you can see the incredible value in doing so. The issue of payment problems is so prevalent in the industry and so detrimental to site/investigator productivity and relationships, that we see companies making this particular solution one of their top priorities.
At first glance, having outdated contact information for sites might seem like a pretty minor issue. But when it results in delays related to required documents, monitoring visits, or clinical supplies, the issue quickly becomes more serious.
It is easy to keep a sponsor or CRO in the loop when a shipping or mailing address changes or when a site coordinator goes out on maternity leave and the interim coordinator should now receive all phone calls and emails. But it is usually not top-of-mind for sites, which can lead to a lot of frustration and rework for the sponsor/CRO.
This strain on the site relationship can be avoided by:
Empowering sites to see the contact information on file for them at all times
Providing sites with self-service tools to update their contact information
Periodically prompting site personnel to verify their contact information on file
Implementing this kind of solution is simple and effective. Consider this:
Every six months, the site coordinator receives a push notification on her mobile phone to verify that the contact information on file for the site is correct.
During her review, she notices is that the address you have designated for shipping is out of date. Their medical campus now has a centralized shipping and receiving location that’s different from the office where they see patients.
She makes the update and submits the changes. The system automatically verifies the address with the US postal service as being valid, and goes on to check your CTMS to see if the address exists, but has not yet been associated with the site. Because the system is unable to find an exact match, you are alerted that a human needs to weigh in and make a decision.
You review the content of the update and verify that the address is not a slightly different duplicate of an address already in the system. You accept the change, which creates a new address and associates it as the shipping address for the site in all of the integrated systems, and then updates the change request status and notifies the site coordinator.
This simple, yet powerful, solution’s strengths are transparency, self-service, and automation. Just think about how something like this could help your organization avoid communication and mailing/shipping issues with your sites.
Now, for the issue you voted as your #1 concern…
Keeping sites in compliance with their required documents is an ongoing battle for every sponsor and CRO. Considering the volume of documentation involved in a clinical trial, it is no wonder why sites struggle to stay on top of it, or why sponsors and CROs get frustrated when auditors issue findings against them because their sites are out of compliance.
This frustration can be lessened by:
Providing sites with greater visibility into their document compliance status
Automating notifications related to upcoming and past-due document deadlines
Enabling easier document reviews, approvals, and sharing back and forth
Here is an effective solution we’ve seen for this issue:
The site coordinator receives a notification that her CV on file will expire in 30 days. She doesn’t have time at the moment to address the issue, and then accidentally forgets.
Two weeks later, she receives another notification about her CV. Since the issue is more time-sensitive, you also receive a notification.
Following the second notification, she makes the time to update her CV, and then uses the link in the notification to log in. She finds her current CV on file, uploads the new version, and submits. You receive a notification about her activities. She’s able to follow the status of her newly uploaded CV over time, so she knows that you’re taking action on her submission.
The next time she logs in, she can see that all of the site’s documents are in good standing, including her CV.
This approach empowers sites to manage their own document compliance status, makes it easy and convenient to do so, and reassures them that sponsors/CROs are supporting their efforts. You would be amazed how much something so simple can improve relationships with site coordinators.
That brings us to the end of our countdown, so I wanted to briefly mention a couple of ideas for where you can go from here.
If you feel confident that some or all of the issues we discussed today apply to your organization, and you’re interested in seeing the solutions we described in action, just shoot me an email. We’ve built a number of site-facing applications to solve these types of problems and would be happy to share them with you.
On the other hand, if you’re not really sure about the root of the struggles you’re having with your clinical sites, the first step is to conduct the research to find the answers. We’re actually in an engagement right now that centers on this very topic – helping a sponsor organization better understand the “customer journey” experienced by their preferred investigators, and then build out a strategy and roadmap for improving that experience.
With that, I’ll turn it back over to Eugene to touch on these additional resources, and then you’ll see my email address on the final slide. Eugene?
Since this is just a 30-minute webinar, we don’t have time for live Q&A today, but you are welcome to email me directly with questions or comments. If you don’t have time to jot down my email address right now, fear not – all attendees will receive a copy of this webinar, including the slides.