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/
How Data and AI is transforming Pharma.
Value of Data
How Data and AI can transform each and every functions
How organizations should approach the data and AI
What should be the data strategy
What is the future post Covid19
Incyte: Best Practices for Driving Study Start-up Speed and QualityVeeva Systems
In this presentation, Jennifer Heckman, Sr. Director of Clinical Trial Logistics, shared Incyte's plan to leverage Vault Study Startup - a modern, purpose-built solution - to tackle the complex site activation process and increase study start-up speed and quality.
Enabling Proactive Quality Management Across Quality and ManufacturingVeeva Systems
Imagine a quality system that allows you to predict and address quality issues before they occur, increase efficiency through intelligent automation, and increase visibility and collaboration across the supply chain.
Today more than 450 pharma, biotech, medtech, and contract services have turned this vision into reality by redesigning their legacy processes and modernizing their quality infrastructure. Using industry best practices and a strong technology foundation, they standardized business processes across GxPs and unified and connected quality and manufacturing systems for speed and efficiency.
In this presentation, you will learn:
- How digital transformation enables companies to pursue quality excellence
- Opportunities to unify and streamline systems and processes
- Best practices from leading companies to enable proactive quality management
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.
AstraZeneca: A Vision for a Collaborative Clinical EnvironmentVeeva Systems
Slides from AstraZeneca's 2019 Veeva R&D Summit presentation.
After receiving the 2018 Eagle Award for the best sponsor by the Society for Clinical Research Sites (SCRS), AstraZeneca is on an ongoing quest to remain a sponsor of choice for 2019 and beyond. Learn how they are leveraging technology, a unified clinical trial platform, and other strategies to simplify trial conduct at sites.
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/
How Data and AI is transforming Pharma.
Value of Data
How Data and AI can transform each and every functions
How organizations should approach the data and AI
What should be the data strategy
What is the future post Covid19
Incyte: Best Practices for Driving Study Start-up Speed and QualityVeeva Systems
In this presentation, Jennifer Heckman, Sr. Director of Clinical Trial Logistics, shared Incyte's plan to leverage Vault Study Startup - a modern, purpose-built solution - to tackle the complex site activation process and increase study start-up speed and quality.
Enabling Proactive Quality Management Across Quality and ManufacturingVeeva Systems
Imagine a quality system that allows you to predict and address quality issues before they occur, increase efficiency through intelligent automation, and increase visibility and collaboration across the supply chain.
Today more than 450 pharma, biotech, medtech, and contract services have turned this vision into reality by redesigning their legacy processes and modernizing their quality infrastructure. Using industry best practices and a strong technology foundation, they standardized business processes across GxPs and unified and connected quality and manufacturing systems for speed and efficiency.
In this presentation, you will learn:
- How digital transformation enables companies to pursue quality excellence
- Opportunities to unify and streamline systems and processes
- Best practices from leading companies to enable proactive quality management
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.
AstraZeneca: A Vision for a Collaborative Clinical EnvironmentVeeva Systems
Slides from AstraZeneca's 2019 Veeva R&D Summit presentation.
After receiving the 2018 Eagle Award for the best sponsor by the Society for Clinical Research Sites (SCRS), AstraZeneca is on an ongoing quest to remain a sponsor of choice for 2019 and beyond. Learn how they are leveraging technology, a unified clinical trial platform, and other strategies to simplify trial conduct at sites.
Building a Business Case for Quality Management TransformationVeeva Systems
Watch the video here: bit.ly/qualitytransformation_ondemand
Transforming quality management to make it easier to comply with regulations and enable faster and more informed decisions is disruptive – impacting people, processes, and systems. With a business case demonstrating anticipated benefits and savings, teams can justify the costs for change, gain stakeholder support, and ensure alignment.
Many organizations have a fragmented system landscape and outdated or manual quality processes. Leading companies are migrating to modern, cloud systems to enable continuous improvement and accelerate transformation initiatives. They are also re-evaluating processes – adopting current best practices and optimizing investments in new technology.
By watching this on demand webinar with quality experts from PriceWaterhouseCoopers (PwC) and Veeva Systems. You will learn how to build a business case to support quality management transformations including:
• Getting a framework for developing business cases
• How to move from a cost to value structure leveraging Quality 4.0
• Recommendations on calculating TCO with key considerations
• Guidance on navigating complex organizations to gain support
Who Will Benefit:
• VP/Director of Quality and Compliance (QA or QC), Quality Systems
• VP/Director of Information Technology, Quality Management Systems, Quality Systems
• VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain
• Document/Records Managers/ Directors
• Director, Regulatory Operations/ Regulatory Affairs (CMC – Chemistry, Manufacturing, and Control)
• IT System Administrators
• Quality Training Coordinator
Meet Your Presenters:
Jan Paul (JP) Zonnenberg
Partner, Pharmaceutical and Life Sciences Companies, PwC
As a Partner and co-Lead for PwC’s Quality Management Systems Practice, JP’s concentration is in global operations and specifically in quality systems and QMS information technology within the Life Sciences Business Group. With over 28 years’ experience in pharmaceuticals, biotechnology, and medical devices & diagnostics, JP helps leading companies proactively think about developing next generation quality systems to ensure both effective and efficient organizations.
Mike Jovanis
VP Vault Quality, Veeva Systems
As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company's rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.
Created with Mandar Kulkarni and Manish Chhabra for Elements of Software Management at Carnegie Mellon University. Business prognosis created for Veeva Systems, a profitable SaaS company focused on the Life Sciences industry.
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.
Delivering Healthcare Solutions to Combat the Spread of COVID-19Cassia Networks
Learn how Cassia Networks' gateways and VivaLNK's continuous body temperature monitoring sensors are being used in hospitals and clinical centers in China to help fight the spread of COVID-19.
AI in Clinical Trials: From Big Sky to Practical ApplicationVeeva Systems
See presentation slides from SCOPE Summit 2020.
Artificial Intelligence (AI) has made its way into the realm of clinical trials and is reshaping how studies are conducted. This presentation looks at the practical ways AI and process automation are being used effectively today to optimize trial design and execution. See this presentation for a look into how technology is revolutionizing the clinical operations landscape – from the smallest biotech to big pharma.
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.
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
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
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
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.
Streamline Change Control and Variation ManagementVeeva Systems
To watch a recording of this webinar, please visit: https://go.veeva.com/changecontrol_2020
Change control is a complex, multi-step process that requires collaboration across various teams within an organization.
Each year, biopharma companies evaluate hundreds of changes to approved products, many of which have a regulatory impact. Attempting to manage these touchpoints through manual processes can lead to incomplete information, massive distribution delays, and issues with regulatory compliance.
Watch this webinar to hear how Veeva is streamlining change control and variation management for greater transparency and improved decision making.
By attending you will:
- Learn the value of unifying disconnected business processes
- See how streamlining change control improves decision making and lowers risks
Ashley Wentworth, Director of Strategy for Vault Quality, and Marc Gabriel, Sr. Director of Vault RIM, will review the challenges associated with managing these processes and explain how a unified Quality and Regulatory solution automates information exchange across business functions.
Health IT Summit Beverly Hills 2014 – Case Study “Agile Partnerships to Achieve Common Goals in Lab Information Systems” with Pat Cooke, Chief Information Officer, CellNetrix Pathology and Laboratories
Designing an EDC System to Work for a CRAVeeva Systems
Watch the video here: https://bit.ly/3h8gHIU
Targeted source data verification (SDV) might be well established, but many clinical teams are still verifying 100% of their data, making monitoring costly and inefficient.
By warching this on demand webinar, you will hear established RBM experts share the measures and metrics that organizations need to realize the true value of targeted SDV. Learn better ways to implement a risk-based strategy for SDV to ensure that CRAs focus on the most important data and how doing so can:
* Improve data quality
* Speed data collection and analysis
* Result in higher confidence and user satisfaction
Learn how Veeva is reinventing EDC to work for a CRA, creating significant speed and quality improvements.
Who Will Benefit:
Senior professionals working with clinical data/clinical documentation, including:
* Clinical Development/ R&D
* Clinical Data Management
* eClinical Operations
* Data Monitoring & Management
* Development Strategic Operations
* Information Strategy & Analytics, Clinical Informatics & Innovation
* Information Technology, R&D IT
* IT R&D Business Partner
Meet Your Presenters:
Drew Garty
Chief Technology Officer, Veeva Vault CDMS, Veeva
Drew Garty’s career in pharmaceutical technology spans over 20 years and includes significant expertise in EDC, clinical site monitoring, platform integrations and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015. Drew joined Veeva in 2016 as Vice President of Product Management, and led the ground-up design of Veeva’s Vault EDC solution. In his current role of Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners and the industry to set vision and direction of Veeva’s CDMS product.
Dawn Anderson
Managing Director, Life Sciences Strategy and Operations, Deloitte
Dawn has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with clients to design and deploy global operating strategy, performance improvement and technology implementations across the development of new drugs, biologics and devices. Dawn has spoken frequently about clinical transformation and the future of clinical trials, including topics around adaptive design, protocol complexity, risk assessments and the use of technology including virtual trials, digital, mHealth and the use of clinical analytics platforms and cognitive automation in transforming clinical trial delivery.
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.
Covance Accelerator Methodology Delivers Validated Oracle Argus Cloud in Reco...Covance
A global pharmaceutical company wanted to integrate and implement individual safety databases for two of their subsidiaries on the Oracle Argus platform. Read how Covance implemented its Accelerator Methodology to deliver a robust, validated and secure solution in record time.
Building a Business Case for Quality Management TransformationVeeva Systems
Watch the video here: bit.ly/qualitytransformation_ondemand
Transforming quality management to make it easier to comply with regulations and enable faster and more informed decisions is disruptive – impacting people, processes, and systems. With a business case demonstrating anticipated benefits and savings, teams can justify the costs for change, gain stakeholder support, and ensure alignment.
Many organizations have a fragmented system landscape and outdated or manual quality processes. Leading companies are migrating to modern, cloud systems to enable continuous improvement and accelerate transformation initiatives. They are also re-evaluating processes – adopting current best practices and optimizing investments in new technology.
By watching this on demand webinar with quality experts from PriceWaterhouseCoopers (PwC) and Veeva Systems. You will learn how to build a business case to support quality management transformations including:
• Getting a framework for developing business cases
• How to move from a cost to value structure leveraging Quality 4.0
• Recommendations on calculating TCO with key considerations
• Guidance on navigating complex organizations to gain support
Who Will Benefit:
• VP/Director of Quality and Compliance (QA or QC), Quality Systems
• VP/Director of Information Technology, Quality Management Systems, Quality Systems
• VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain
• Document/Records Managers/ Directors
• Director, Regulatory Operations/ Regulatory Affairs (CMC – Chemistry, Manufacturing, and Control)
• IT System Administrators
• Quality Training Coordinator
Meet Your Presenters:
Jan Paul (JP) Zonnenberg
Partner, Pharmaceutical and Life Sciences Companies, PwC
As a Partner and co-Lead for PwC’s Quality Management Systems Practice, JP’s concentration is in global operations and specifically in quality systems and QMS information technology within the Life Sciences Business Group. With over 28 years’ experience in pharmaceuticals, biotechnology, and medical devices & diagnostics, JP helps leading companies proactively think about developing next generation quality systems to ensure both effective and efficient organizations.
Mike Jovanis
VP Vault Quality, Veeva Systems
As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company's rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.
Created with Mandar Kulkarni and Manish Chhabra for Elements of Software Management at Carnegie Mellon University. Business prognosis created for Veeva Systems, a profitable SaaS company focused on the Life Sciences industry.
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.
Delivering Healthcare Solutions to Combat the Spread of COVID-19Cassia Networks
Learn how Cassia Networks' gateways and VivaLNK's continuous body temperature monitoring sensors are being used in hospitals and clinical centers in China to help fight the spread of COVID-19.
AI in Clinical Trials: From Big Sky to Practical ApplicationVeeva Systems
See presentation slides from SCOPE Summit 2020.
Artificial Intelligence (AI) has made its way into the realm of clinical trials and is reshaping how studies are conducted. This presentation looks at the practical ways AI and process automation are being used effectively today to optimize trial design and execution. See this presentation for a look into how technology is revolutionizing the clinical operations landscape – from the smallest biotech to big pharma.
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.
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
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
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
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.
Streamline Change Control and Variation ManagementVeeva Systems
To watch a recording of this webinar, please visit: https://go.veeva.com/changecontrol_2020
Change control is a complex, multi-step process that requires collaboration across various teams within an organization.
Each year, biopharma companies evaluate hundreds of changes to approved products, many of which have a regulatory impact. Attempting to manage these touchpoints through manual processes can lead to incomplete information, massive distribution delays, and issues with regulatory compliance.
Watch this webinar to hear how Veeva is streamlining change control and variation management for greater transparency and improved decision making.
By attending you will:
- Learn the value of unifying disconnected business processes
- See how streamlining change control improves decision making and lowers risks
Ashley Wentworth, Director of Strategy for Vault Quality, and Marc Gabriel, Sr. Director of Vault RIM, will review the challenges associated with managing these processes and explain how a unified Quality and Regulatory solution automates information exchange across business functions.
Health IT Summit Beverly Hills 2014 – Case Study “Agile Partnerships to Achieve Common Goals in Lab Information Systems” with Pat Cooke, Chief Information Officer, CellNetrix Pathology and Laboratories
Designing an EDC System to Work for a CRAVeeva Systems
Watch the video here: https://bit.ly/3h8gHIU
Targeted source data verification (SDV) might be well established, but many clinical teams are still verifying 100% of their data, making monitoring costly and inefficient.
By warching this on demand webinar, you will hear established RBM experts share the measures and metrics that organizations need to realize the true value of targeted SDV. Learn better ways to implement a risk-based strategy for SDV to ensure that CRAs focus on the most important data and how doing so can:
* Improve data quality
* Speed data collection and analysis
* Result in higher confidence and user satisfaction
Learn how Veeva is reinventing EDC to work for a CRA, creating significant speed and quality improvements.
Who Will Benefit:
Senior professionals working with clinical data/clinical documentation, including:
* Clinical Development/ R&D
* Clinical Data Management
* eClinical Operations
* Data Monitoring & Management
* Development Strategic Operations
* Information Strategy & Analytics, Clinical Informatics & Innovation
* Information Technology, R&D IT
* IT R&D Business Partner
Meet Your Presenters:
Drew Garty
Chief Technology Officer, Veeva Vault CDMS, Veeva
Drew Garty’s career in pharmaceutical technology spans over 20 years and includes significant expertise in EDC, clinical site monitoring, platform integrations and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015. Drew joined Veeva in 2016 as Vice President of Product Management, and led the ground-up design of Veeva’s Vault EDC solution. In his current role of Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners and the industry to set vision and direction of Veeva’s CDMS product.
Dawn Anderson
Managing Director, Life Sciences Strategy and Operations, Deloitte
Dawn has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with clients to design and deploy global operating strategy, performance improvement and technology implementations across the development of new drugs, biologics and devices. Dawn has spoken frequently about clinical transformation and the future of clinical trials, including topics around adaptive design, protocol complexity, risk assessments and the use of technology including virtual trials, digital, mHealth and the use of clinical analytics platforms and cognitive automation in transforming clinical trial delivery.
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.
Covance Accelerator Methodology Delivers Validated Oracle Argus Cloud in Reco...Covance
A global pharmaceutical company wanted to integrate and implement individual safety databases for two of their subsidiaries on the Oracle Argus platform. Read how Covance implemented its Accelerator Methodology to deliver a robust, validated and secure solution in record time.
What’s happening in Banking World?
The entire landscape is very competitive and banks today are evolving. Banks are relying more and more on technology to reach customers and deliver services in short span of time. It is becoming important for them to be consistent and deliver quality customer services using technology to reach, expand and deliver faster and better services.
Adding additional services and transactions via technology, integrating with legacy systems and delivering using new delivery methods are becoming a norm. The banking industry is embracing newer technology to grow their market share. With technology, banks today are global players and no more local.
Challenges
Challenges in the multiple industries are similar but in Banking, there are specific challenges, which makes it unique, which are
• Frequently changing market and regulatory requirements
• High data confidentiality requirements
• Complex system landscapes including legacy systems
• Newer technologies such as mobile and web services
• Enterprise banking integration – Core banking, Corporate Banking and Retail Banking
• Application performance – Internal and External
Approaches to meet the challenges
It is very important that banks and financial establishments conduct regression tests over the entire application lifecycle for every release and also maintain test suites for each release using effective version control system linked to requirements, test cases, test scenarios and realistic test data. Based on this, an effective testing approach can be taken individually or by combination of the following to achieve the desired results:
• Risk-based testing
• Automation - Legacy, Web, Mobile
• Test data management
• Compliance / Statutory testing
• Performance and Capacity engineering
• Off-shoring
Designed for human interface, Y Prime’s CTMS provides an intuitive and easy to use system with a focus on the ability to access data easily and quickly. The system has streamlined study creation, utilizing our industry research to help managers forecast and execute clinical trials in an efficient, intuitive manner, meaning set-up and training time are minimal. Fully supported by Y Prime’s industry experts, our CTMS is designed with a flexible framework allowing it to evolve with changing business processes, hence meeting the potentially endless requirements of all trial management needs. Our CTMS is available with multiple, flexible pricing models. - See more at: http://www.y-prime.com/products/#section-4
CareSolutions™ Data Warehouse takes data feeds from NHS systems and this comprehensive, up to date view of all data can then provide improved reporting and analysis. The Data Warehouse from 6PM is a very powerful data management tool allowing the Trust, through a graphical front-end, to create new data feeds and data quality rules with exception reporting and then schedule when these should all happen and in what order.
The solution also has multi-threading capability allowing the Trust to load multiple data sources at once which reduces the window of operation required for overnight data feeds.
Our additional modules also include 18WW and SUS reporting which are all standard applications with the product.
2016 AWS Life Sciences Day | New Jersey – July 26th, 2016Amazon Web Services
In the AWS Life Sciences presentation you’ll learn best practices for using AWS for pharmaceutical, genomics, and biotechnology workloads for the Life Sciences industry with a deep technical overview and demos. Topics to be covered in this presentation include architecting for validated workloads on AWS, building IoT applications for healthcare, and hybrid storage options for the Life Sciences. You will also see how cloud technology partner, Cognizant, is helping Life Science organizations architect for high availability & business continuity.
Logo
Linguistic harmony in the Tower of Babel; how Amgen joins reference data from bench to bedside
The challenges associated with managing reference data create complexity and expense across all industries - in Life Sciences, Financial Services and Manufacturing, the problem is particularly acute.
Amgen – an American multinational biopharmaceutical company – tackles the reference data issue by creating a linked vocabulary that is leveraged across the Pharma pipeline to streamline processes and enable faster time to market.
How Allscripts Streamlined Root Cause Analysis - AppSphere16AppDynamics
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o Ranked performance issues
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o Ability to evaluate and numerically state performance differences between different code bases’ server configurations
Key takeaways:
o How to employ AppDynamics to free top SME talent from mundane RCA work
o How to use AppDynamics to evaluate a solution
o Enabling SaaS development operations to better communicate areas of concern to development
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Here is something new! In our next Connector Corner webinar, we will demonstrate how you can use a single workflow to:
Create a campaign using Mailchimp with merge tags/fields
Send an interactive Slack channel message (using buttons)
Have the message received by managers and peers along with a test email for review
But there’s more:
In a second workflow supporting the same use case, you’ll see:
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- Grid simulation tools, such as power flows, security analyses (with or without remedial actions) and sensitivity analyses;
The framework is mostly written in Java, with a Python binding so that Python developers can access PowSyBl functionalities as well.
What you will learn during the webinar:
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💥 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
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Watch this recorded webinar about real-time monitoring of application performance. See how to integrate Apache JMeter, the open-source leader in performance testing, with InfluxDB, the open-source time-series database, and Grafana, the open-source analytics and visualization application.
In this webinar, we will review the benefits of leveraging InfluxDB and Grafana when executing load tests and demonstrate how these tools are used to visualize performance metrics.
Length: 30 minutes
Session Overview
-------------------------------------------
During this webinar, we will cover the following topics while demonstrating the integrations of JMeter, InfluxDB and Grafana:
- What out-of-the-box solutions are available for real-time monitoring JMeter tests?
- What are the benefits of integrating InfluxDB and Grafana into the load testing stack?
- Which features are provided by Grafana?
- Demonstration of InfluxDB and Grafana using a practice web application
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https://www.rttsweb.com/jmeter-integration-webinar
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The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Unsubscribed: Combat Subscription Fatigue With a Membership Mentality by Head...
Case Study SpecsaversCase specsavers-en
1. sqs.com
Case Study – Retail & Logistics
Specsavers
SQS helps Specsavers to deliver fundamental business process change
and improve quality for the first major Oracle system to go live
Background
Challenge
Specsavers is a Partnership of nearly 2,000 locally-run businesses, committed to delivering high quality, affordable optical
and hearing care in the communities they serve. It is the largest
privately owned optical retailer in the world, operating across
10 countries.
Specsavers set about rationalising its entire corporate data
management strategy by adopting a master data management
(MDM) approach to data handling using Oracle’s Product Data
Hub. They wanted to ensure that data from the Product Hub
was available across all its countries. As many of Specsavers
international operations operated different legacy systems, the
team needed to ensure that the data flows between the new
Product Data Hub and the legacy systems were both reliable
and scalable to cope with expected volumes.
Specsavers operates on a joint venture basis, with each store
owned and operated by local partners, supported by key specialists in support offices, who provide a range of services, such
as marketing, accounting, IT and wholesaling, among others.
The first set of products to be migrated to the new MDM system
were contact lenses, a category containing over 120,000 products. Data cleansing was a key issue and information in the
new Oracle Product Hub had to be correct, as it would become
the primary source for product data across all of Specsavers’
main operational systems.
2. Solution
SQS conducted testing and quality assurance for the MDM
programme using it’s onshore and offshore teams in the UK
and in India. The test team carried out system and large scale
integration testing with multiple legacy systems. This ensured
that a single version of product data could be created in the
Product Data Hub, enabling distribution to, and use in, all the
downstream legacy systems. The testing was of such calibre
that zero functional defects leaked from system testing into
User Acceptance Testing. Saving Specsavers the time, effort
and cost that would have been involved in unnecessary rework.
Both organisations worked closely to improve the quality of the
application throughout the process.
Close collaboration played an important part in ensuring the
programme’s success and SQS tailored its offshore engagement approach to suit Specsavers’ preferred operating model.
Technical experts and business analysts from Specsavers
frequently worked alongside SQS teams in India and the UK,
ensuring the free flow of information between all parties.
“We worked hard on making this programme a collaborative venture, and the SQS team went to some
lengths to ensure that they were fully engaged and
seen as an integral part of the programme team. SQS
assured, from a quality governance point of view,
that we were rigorous and robust through the entire
process – hence the high quality outcome for the
programme as a whole.”
Rick Kocher, MDM programme Director, Specsavers
Contact
If you are interested in SQS’ service offering regarding
testing and quality management for the Retail & Logistics
industry, please do not hesitate to send us an e-mail:
info@sqs.com
Benefits for the Customer
The MDM programme delivered:
• To budget and on time
• Eighteen months after inception with no major defects
discovered after the system went into production.
• Fundamental change in the way that Specsavers managed
its operational data, both in terms of IT systems and organisational change with new teams created as custodians of
that data.
Although the level and rigour of testing was more intensive than
might typically be conducted on a system of this complexity,
this paid dividends in the quality of the system delivered to the
live environment.
SQS – the world’s leading specialist in software quality