Veeva and Idorsia share how your organization can leverage a unified clinical operating model and drive new levels of efficiency across the entire clinical ecosystem.
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/
Speed Clinical Trials from Start to Close: The Path to a Modern CTMSVeeva Systems
Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo
Improving Clinical Trial Performance: Part 3 - Streamline Trial Management wi...Veeva Systems
Henry Galio shares findings from the Unified Clinical Operations Survey and how research organizations can streamline trial management with Veeva Vault CTMS. Access the webinar > http://go.veeva.com/ModernCTMS
Moving to unified PV: Transforming Safety with End-to-end PV SolutionsVeeva Systems
New technologies and approaches to safety and pharmacovigilance are enabling end-to-end processes for greater collaboration and oversight.
During Pharmacovigilance World 2021, Jen Markey, VP Vault Safety Strategy Europe, shared how you can leverage a unified PV solution to improve outsourcing, streamline safety, and make compliance easier.
For more information visit:
www.veeva.com/eu/products/vault-safety
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.
Efficient Trial Management through Unified CTMS and Study Start-upVeeva Systems
Learn the benefits of a unified clinical landscape, particularly how clinical trial management software (CTMS) and study start-up applications lead to more efficient trial management when working in concert with one another.
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.
The latest in advanced technology and digital capabilities are changing the way the life sciences industry develops new, life-changing treatments for patients.
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/
Speed Clinical Trials from Start to Close: The Path to a Modern CTMSVeeva Systems
Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo
Improving Clinical Trial Performance: Part 3 - Streamline Trial Management wi...Veeva Systems
Henry Galio shares findings from the Unified Clinical Operations Survey and how research organizations can streamline trial management with Veeva Vault CTMS. Access the webinar > http://go.veeva.com/ModernCTMS
Moving to unified PV: Transforming Safety with End-to-end PV SolutionsVeeva Systems
New technologies and approaches to safety and pharmacovigilance are enabling end-to-end processes for greater collaboration and oversight.
During Pharmacovigilance World 2021, Jen Markey, VP Vault Safety Strategy Europe, shared how you can leverage a unified PV solution to improve outsourcing, streamline safety, and make compliance easier.
For more information visit:
www.veeva.com/eu/products/vault-safety
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.
Efficient Trial Management through Unified CTMS and Study Start-upVeeva Systems
Learn the benefits of a unified clinical landscape, particularly how clinical trial management software (CTMS) and study start-up applications lead to more efficient trial management when working in concert with one another.
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.
The latest in advanced technology and digital capabilities are changing the way the life sciences industry develops new, life-changing treatments for patients.
IMS Health Clinical Trial Optimization SolutionsQuintilesIMS
IMS Health's Linda T. Drumright, general manager, Clinical Trial Optimization Solutions presents at the 3rd Annual Patient Recruitment & Retention Summit 2014 - San Francisco, CA
Accenture is leading the next evolution of Regulatory by applying leading edge solutions across the drug and device lifecycle that unify innovative technologies with compliance-focused processes. Visit https://accntu.re/2YqL18r to learn more.
How a Semantic Layer Makes Data Mesh Work at ScaleDATAVERSITY
Data Mesh is a trending approach to building a decentralized data architecture by leveraging a domain-oriented, self-service design. However, the pure definition of Data Mesh lacks a center of excellence or central data team and doesn’t address the need for a common approach for sharing data products across teams. The semantic layer is emerging as a key component to supporting a Hub and Spoke style of organizing data teams by introducing data model sharing, collaboration, and distributed ownership controls.
This session will explain how data teams can define common models and definitions with a semantic layer to decentralize analytics product creation using a Hub and Spoke architecture.
Attend this session to learn about:
- The role of a Data Mesh in the modern cloud architecture.
- How a semantic layer can serve as the binding agent to support decentralization.
- How to drive self service with consistency and control.
Watch full webinar here: https://bit.ly/3mdj9i7
You will often hear that "data is the new gold"? In this context, data management is one of the areas that has received more attention from the software community in recent years. From Artificial Intelligence and Machine Learning to new ways to store and process data, the landscape for data management is in constant evolution. From the privileged perspective of an enterprise middleware platform, we at Denodo have the advantage of seeing many of these changes happen.
In this webinar, we will discuss the technology trends that will drive the enterprise data strategies in the years to come. Don't miss it if you want to keep yourself informed about how to convert your data to strategic assets in order to complete the data-driven transformation in your company.
Watch this on-demand webinar as we cover:
- The most interesting trends in data management
- How to build a data fabric architecture?
- How to manage your data integration strategy in the new hybrid world
- Our predictions on how those trends will change the data management world
- How can companies monetize the data through data-as-a-service infrastructure?
- What is the role of voice computing in future data analytic
Accenture Cloud Platform: Control, Manage and Govern the Enterprise Cloudaccenture
The Accenture Cloud Platform is a multi-cloud management platform that enables organizations to manage all of their enterprise cloud
resources—public and private—and automate and accelerate solution delivery.
Building an Analytics CoE (Center of Excellence)Rahul Saxena
This deck is from a workshop I conducted at the Indian Institute of Management, Bangalore (IIMB) on 20th July, 2013.
Agenda:
* What does the organization want to do with analytics? What is the role of the CoE that they envision?
* What is the organizational context? Current providers of analytics? Leadership support?
* What will the Analytics CoE need to be like (now and in the future, up to the planning horizon)?
* Where do we stand with analytics capabilities now, compared to what we need?
* How will we evolve the CoE? Set expectations, drive the evolution, establish the value.
Your next RIM solution - 3 key considerations for your moveV E R A
Considering to move to a new Regulatory Information Management system? Have a look at our pick of the 3 key considerations while moving to a new RIM system.
If you wish to receive more information - write us at info@cunesoft.com or visit our page https://cunesoft.com/en/products/rim/
Decentralized Clinical Trials, presentaiton by Craig Lipset for mHealth IsraelLevi Shapiro
Decentralized Clinical Trials, presentaiton by Craig Lipset for mHealth Israel, April 20, 2021. Origin Story: Centralization Enables Decentralization. Analogous potential for centralization
leading to decentralization in clinical trials. Decentralization: Purpose and potential benefits, including resilience and
business continuity. Pre-Pandemic DCT Timeline: 17-year History Prior to COVID-19. Seasons of Decentralization in 2020. Spring of Continuity, Summer of Restarts, Fall of Commitment, Winter of Pathways to Scale. 79% of sponsors / CROs increasing DCT. 90% of participants experiencing change. 75% focus on going hybrid. 73% of Sites Will continue to use telemedicine beyond the pandemic. 76% have accelerated their DCT Strategies.Leading Implementation Strategy: Pairing DCT Toolkit to Study Needs. Identify the decentralized research methods and tools needed by the medicine portfolio. Ensure aligned SOPs & training, identify new partners, modify protocols/templates. Pair the “right” method/tool to each study
based upon diverse criteria. Barriers to Scaled Adoption of Decentralized Trials: Regulatory ambiguity, Global variability, Technology interop & data flow, Investigator & patient readiness, Endpoint limitations, Organization culture. Forecasts and Futures. Choice & Flexibility for Participants on a Visit-by-Visit Basis. Research Sites Empowered to Use Their Existing Technology. New Opportunities to Engage Treating Physicians Enables Research as a Care Option. Observational
“All-Comer” Studies and Platform Trials with DCT Bring Research to People.
eCOA and ePRO and Their Use in Clinical Trials_pptxClinosolIndia
Virtual clinical trials are becoming even more popular because of technology advances. They offer enormous benefits to sponsors and patients. However, there are challenges. One of the key elements of a virtual clinical trial is ePRO and eCOA.
Patient-reported outcome (PRO) endpoints are often necessary to adequately evaluate the treatment benefit provided by new medical products (e.g., drugs) in clinical trials.
The movement from paper-based to electronic PRO (ePRO) data collection has enhanced the integrity and accuracy of PRO data in clinical trials.
The US Food and Drug Administration has made it clear that electronic capture of clinical trial source data is preferred over paper-based data collection.
Testing the Migration of Monolithic Applications to Microservices on the CloudNagarro
Are you considering migrating from monolithic applications to microservices on the cloud? Check out this deck to understand the differences between monolithic applications and microservices, why microservices is a better option, and learn about cloud testing.
Mindtree provides cloud services to help believe that digital transformation of healthcare is only possible by embracing & adopting the cloud. Click her to know more.
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
Best practices for implementing and maintaining successful standardsVeeva Systems
Watch the video here: https://bit.ly/3uvar1u
This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.
* Understand what to standardize
* Learn several approaches to standards development and when they make sense
* Ensure alignment with key stakeholders
* Maintain and govern standards over time
* Reduce overall configuration time
Who Will Benefit:
* Clinical Data (manager/director/head of) Clinical ops
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
* Data standards
* Quantitative sciences
* Informatics
* Data monitoring
* Clinical leads
* Study managers
* Clinical study
* Data manager
* CRA
* CDISC
Meet Your Presenters:
Carla Reis
Director, Client Services, 4G Clinical
Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.
Paul MacDonald
Senior Director, Strategy Vault CDMS, Veeva Systems
Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.
Driving Clinical Trial Efficiency in an Outsourced ModelVeeva Systems
Explore how a unified operating environment increases operational efficiency, simplifies trial collaboration, and improves study quality in an outsourced model. Slides from Veeva's session at 2019 Outsourcing in Clinical Trials West Coast.
In a unified eClinical infrastructure, formerly disparate clinical study systems are merged.
Users no longer work in “CTMS” or “eTMF”, but in a harmonized clinical infrastructure where a single source of truth is a given, and changes and additions automatically impact the appropriate data, documents and processes.
This presentation will show you what clinical unification is, its benefits and how it can be achieved.
IMS Health Clinical Trial Optimization SolutionsQuintilesIMS
IMS Health's Linda T. Drumright, general manager, Clinical Trial Optimization Solutions presents at the 3rd Annual Patient Recruitment & Retention Summit 2014 - San Francisco, CA
Accenture is leading the next evolution of Regulatory by applying leading edge solutions across the drug and device lifecycle that unify innovative technologies with compliance-focused processes. Visit https://accntu.re/2YqL18r to learn more.
How a Semantic Layer Makes Data Mesh Work at ScaleDATAVERSITY
Data Mesh is a trending approach to building a decentralized data architecture by leveraging a domain-oriented, self-service design. However, the pure definition of Data Mesh lacks a center of excellence or central data team and doesn’t address the need for a common approach for sharing data products across teams. The semantic layer is emerging as a key component to supporting a Hub and Spoke style of organizing data teams by introducing data model sharing, collaboration, and distributed ownership controls.
This session will explain how data teams can define common models and definitions with a semantic layer to decentralize analytics product creation using a Hub and Spoke architecture.
Attend this session to learn about:
- The role of a Data Mesh in the modern cloud architecture.
- How a semantic layer can serve as the binding agent to support decentralization.
- How to drive self service with consistency and control.
Watch full webinar here: https://bit.ly/3mdj9i7
You will often hear that "data is the new gold"? In this context, data management is one of the areas that has received more attention from the software community in recent years. From Artificial Intelligence and Machine Learning to new ways to store and process data, the landscape for data management is in constant evolution. From the privileged perspective of an enterprise middleware platform, we at Denodo have the advantage of seeing many of these changes happen.
In this webinar, we will discuss the technology trends that will drive the enterprise data strategies in the years to come. Don't miss it if you want to keep yourself informed about how to convert your data to strategic assets in order to complete the data-driven transformation in your company.
Watch this on-demand webinar as we cover:
- The most interesting trends in data management
- How to build a data fabric architecture?
- How to manage your data integration strategy in the new hybrid world
- Our predictions on how those trends will change the data management world
- How can companies monetize the data through data-as-a-service infrastructure?
- What is the role of voice computing in future data analytic
Accenture Cloud Platform: Control, Manage and Govern the Enterprise Cloudaccenture
The Accenture Cloud Platform is a multi-cloud management platform that enables organizations to manage all of their enterprise cloud
resources—public and private—and automate and accelerate solution delivery.
Building an Analytics CoE (Center of Excellence)Rahul Saxena
This deck is from a workshop I conducted at the Indian Institute of Management, Bangalore (IIMB) on 20th July, 2013.
Agenda:
* What does the organization want to do with analytics? What is the role of the CoE that they envision?
* What is the organizational context? Current providers of analytics? Leadership support?
* What will the Analytics CoE need to be like (now and in the future, up to the planning horizon)?
* Where do we stand with analytics capabilities now, compared to what we need?
* How will we evolve the CoE? Set expectations, drive the evolution, establish the value.
Your next RIM solution - 3 key considerations for your moveV E R A
Considering to move to a new Regulatory Information Management system? Have a look at our pick of the 3 key considerations while moving to a new RIM system.
If you wish to receive more information - write us at info@cunesoft.com or visit our page https://cunesoft.com/en/products/rim/
Decentralized Clinical Trials, presentaiton by Craig Lipset for mHealth IsraelLevi Shapiro
Decentralized Clinical Trials, presentaiton by Craig Lipset for mHealth Israel, April 20, 2021. Origin Story: Centralization Enables Decentralization. Analogous potential for centralization
leading to decentralization in clinical trials. Decentralization: Purpose and potential benefits, including resilience and
business continuity. Pre-Pandemic DCT Timeline: 17-year History Prior to COVID-19. Seasons of Decentralization in 2020. Spring of Continuity, Summer of Restarts, Fall of Commitment, Winter of Pathways to Scale. 79% of sponsors / CROs increasing DCT. 90% of participants experiencing change. 75% focus on going hybrid. 73% of Sites Will continue to use telemedicine beyond the pandemic. 76% have accelerated their DCT Strategies.Leading Implementation Strategy: Pairing DCT Toolkit to Study Needs. Identify the decentralized research methods and tools needed by the medicine portfolio. Ensure aligned SOPs & training, identify new partners, modify protocols/templates. Pair the “right” method/tool to each study
based upon diverse criteria. Barriers to Scaled Adoption of Decentralized Trials: Regulatory ambiguity, Global variability, Technology interop & data flow, Investigator & patient readiness, Endpoint limitations, Organization culture. Forecasts and Futures. Choice & Flexibility for Participants on a Visit-by-Visit Basis. Research Sites Empowered to Use Their Existing Technology. New Opportunities to Engage Treating Physicians Enables Research as a Care Option. Observational
“All-Comer” Studies and Platform Trials with DCT Bring Research to People.
eCOA and ePRO and Their Use in Clinical Trials_pptxClinosolIndia
Virtual clinical trials are becoming even more popular because of technology advances. They offer enormous benefits to sponsors and patients. However, there are challenges. One of the key elements of a virtual clinical trial is ePRO and eCOA.
Patient-reported outcome (PRO) endpoints are often necessary to adequately evaluate the treatment benefit provided by new medical products (e.g., drugs) in clinical trials.
The movement from paper-based to electronic PRO (ePRO) data collection has enhanced the integrity and accuracy of PRO data in clinical trials.
The US Food and Drug Administration has made it clear that electronic capture of clinical trial source data is preferred over paper-based data collection.
Testing the Migration of Monolithic Applications to Microservices on the CloudNagarro
Are you considering migrating from monolithic applications to microservices on the cloud? Check out this deck to understand the differences between monolithic applications and microservices, why microservices is a better option, and learn about cloud testing.
Mindtree provides cloud services to help believe that digital transformation of healthcare is only possible by embracing & adopting the cloud. Click her to know more.
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
Best practices for implementing and maintaining successful standardsVeeva Systems
Watch the video here: https://bit.ly/3uvar1u
This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.
* Understand what to standardize
* Learn several approaches to standards development and when they make sense
* Ensure alignment with key stakeholders
* Maintain and govern standards over time
* Reduce overall configuration time
Who Will Benefit:
* Clinical Data (manager/director/head of) Clinical ops
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
* Data standards
* Quantitative sciences
* Informatics
* Data monitoring
* Clinical leads
* Study managers
* Clinical study
* Data manager
* CRA
* CDISC
Meet Your Presenters:
Carla Reis
Director, Client Services, 4G Clinical
Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.
Paul MacDonald
Senior Director, Strategy Vault CDMS, Veeva Systems
Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.
Driving Clinical Trial Efficiency in an Outsourced ModelVeeva Systems
Explore how a unified operating environment increases operational efficiency, simplifies trial collaboration, and improves study quality in an outsourced model. Slides from Veeva's session at 2019 Outsourcing in Clinical Trials West Coast.
In a unified eClinical infrastructure, formerly disparate clinical study systems are merged.
Users no longer work in “CTMS” or “eTMF”, but in a harmonized clinical infrastructure where a single source of truth is a given, and changes and additions automatically impact the appropriate data, documents and processes.
This presentation will show you what clinical unification is, its benefits and how it can be achieved.
Steps to Overcome Information Overlaod in Clincial ResearchVeeva Systems
Discover new strategies that reduce information overload and simplify how sites, sponsors, and CROs work together throughout the clinical trial process. Watch the full webinar here: https://go.veeva.com/ClinicalResearchWebinar-acrp
Collaborate Effectively to Transform Clinical TrialsVeeva Systems
View slides from Veeva's plenary session at ExL's 8th Trial Master File Summit to:
• Learn opportunities to transform trial execution through greater TMF collaboration
• Explore innovative ways to enhance collaboration by automating the exchange of TMF data between sponsors, CROs, and sites
• Learn how to gain and leverage continuous visibility of clinical data exchange to improve oversight, compliance, and decision-making
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
Steps to Overcome Information Overload in Clinical ResearchVeeva Systems
See slides from Veeva's Outsourcing Clinical Trials West Coast presentation.
This deck explores the driving forces behind the industrywide move to streamline information exchange in clinical trials. Learn about modern technologies that improve how organizations work together across the clinical environment and discover new approaches to sharing trial information with study partners.
The State of Unifying Clinical Systems, Processes, and Stakeholder CollaborationVeeva Systems
Explore new findings from the Veeva 2019 Unified Clinical Operations Survey, including drivers and barriers to unifying clinical systems and processes. Get the full report here: http://bit.ly/31wpWZ0
Tufts Research: Strategies from Data Management Leaders to Speed Clinical TrialsVeeva Systems
Watch the video here: https://bit.ly/3wChmGQ
Learn how top pharmas and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. In this webinar you'll gain insights into:
* Taking an agile approach to database build
* Reducing UAT timelines with a risk-based approach
* Driving innovation at your organization
This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.
Meet Your Presenters:
Ken Getz
Director of Sponsored Programs, Tufts CSDD
Richard Young
Vice President, Vault EDC, Veeva Systems
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
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Veeva Systems
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
Clireo eTMF Solution by Arivis
What is Clireo?
• Comprehensive Software and Service enabling the Trial Master File
• Compliant with the DIA Trial Master File Reference Model Version 3
• Assign access and maintain control of Sites, Vendors, and Auditors for content.
• Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF.
• Part 21 CFR 11 Digital signatures allow for faster turn around time on documents.
• Ability to quickly disseminate new information to users that the information is relevant to.
• Vendors and Sites can upload documentation and data directly into Clireo.
• Unlimited storage capacity assures that all documentation can be held in one location.
• No additional hardware required to implement.
• Dashboard reports on the status of sites and documents to easily identify missing or lagging information.
• Protect documents against unauthorized modification.
• Supports single or multiple file uploads with single screen metadata tagging.
• Centralized Documentation-Access from Anywhere.
• Resolve document issues faster.
• Ability to search documents in many ways.
• Dramatic Reduction in the need to print, scan, and store multiple copies in several locations.
• Link documents together to create a complete document package.
We have been serving eTMF customers since 2007.
Email now to schedule a demonstration and see how Clireo and Arivis can help you with your eTMF needs.
Tricia McQuarrie
Clinical Operations Manager tricia.mcquarrie@arivis.com
Arivis, Inc.
2198 E. Camelback Road
Phoenix, AZ 85016
Tel. 602-957-2150
www.m3.arivis.com
To watch the full webinar, register here: https://go.veeva.com/modernquality_webinar2020
Watch this short video to learn more about our upcoming webinar “Modernizing Quality Management”: http://bit.ly/2U8cIAp
Addressing drug shortages and the development of new complex therapies — two top challenges facing manufacturing organizations — require the transformation of quality management using modern systems.
In this webinar, Veeva’s Mike Jovanis, VP of Vault Quality, and Ashley Wentworth, director of quality strategy, will discuss how modern quality systems automate business processes, connect global partners and suppliers, and enable manufacturing agility.
Register for this webinar to learn how:
• Industry trends are driving quality management transformation
• Digitizing manufacturing operations can drive quality improvements
• Companies are benefitting from modern quality systems based on real-world examples
Learning Level:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who Should Attend:
• Employees of pharma manufacturing, generics, and CMO organizations
• Quality professionals involved with quality systems, quality operations, or GxP Compliance
Speakers:
Michael Jovanis, VP Vault Quality, Veeva Systems
Ashley Wentworth, Director Vault Quality, Veeva Systems
Shorten Database Builds by 60% with Agile DesignVeeva Systems
Watch the video here: https://bit.ly/3f64wJZ
See the Packed #SCDM2019 Session
Radical time savings aren’t possible with incremental process improvements. An agile EDC enables process transformation that shortens database builds by 40-60%. Join a live webinar of the packed SCDM product showcase to hear the technologies and processes behind those savings, including real-time UAT, data-driven rules and dynamics, and easy amendments.
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.
Trends und Anwendungsbeispiele im Life Science BereichAWS Germany
Der Vortrag gibt eine Übersicht über den Stand der Adaption von Cloud Services in der pharmazeutischen Industrie. Dazu werden, entlang der pharmazeutischen Wertschöpfungskette, typische Beispielanwendungen skizziert und exemplarisch Problemstellungen erörtert.
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
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.
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
Similar to Improve Clinical Trial Processes With a Unified Platform (20)
Strategies and Best Practices for Transforming Enterprise TrainingVeeva Systems
Webinar with Carol Benson, associate director of quality systems at Incyte, and Kent Malmros, senior director of Vault Training. They discuss best practices and strategies for successfully transforming learning management systems. There are benefits of starting learning management system selection and implementation with diligent and comprehensive change management approaches.
Topics include:
- Organizational governance strategies for LMS
- How to build on a foundation of GxP compliance
- How to build cross-functional oversight
- Selecting the right learning technologies to eliminate all paper processes
- Best practices for delivering a single system
The Industry’s Move Toward Digitally Connected Clinical TrialsVeeva Systems
The rapid adoption of decentralized trials is causing significant challenges – sites are burdened by too many technologies and the use of multiple patient-facing applications adds complexity for patients.
In these slides, we discuss the implications of decentralized trials, share findings from the Veeva Digital Clinical Trials Survey, and explore how clinical leaders are accelerating digital transformation to make studies more site and patient-centric.
Access the Veeva Digital Clinical Trials Survey Report (https://bit.ly/35eAeDn) for additional insights from more than 280 clinical leaders worldwide on the industry’s progress toward digital trial strategies, lessons learned, and what lies ahead.
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
Enhance Learning Efficiency in LIfe Sciences with Industry-Leading Learning C...Veeva Systems
See how an end-to-end solution enables customers to modernize training while streamlining resources and improving learning outcomes. Join us to learn how combining best-in-class training content and LMS technology improves efficiency and brings strategic value to your organization.
Join this session to learn:
How adding a standard GxP content library to your LMS increases training efficiency
The best place to start with eLearning content
Scaling your use of a GxP training library based on organizational maturity
Partnering with Veeva for your ongoing learning strategy needs
Reimagine patient safety 2030 governance through a unified safety platformVeeva Systems
Technology disruptions and healthcare transformation are shifting the roles of QPPV's and senior safety leaders to a more predictive, preventative and participatory safety ecosystem.
During the DIA QPPV Forum, Sharmila Sabaratnam, Senior Director Vault Safety Strategy, shared how you can improve collaboration, benefit-risk data flow and quality and generate insights to maximise patient outcome and minimise avoidable harm through medical governance oversight.
For more information visit:
www.veeva.com/eu/products/vault-safety
Reshaping Global ICSR Reporting to Deliver Real-time Visibility and OversightVeeva Systems
Learn how you can reshape global ICSR reporting to deliver real-time visibility and oversight.
In this presentation we discuss:
- Challenges and approaches to safety data management and ICRS reporting
- How technology is making it easier to comply with global and regional requirements
- Considerations for incorporating affiliates into one pharmacovigilance solution
- Strategies for adopting a single multi-lingual safety solution
View the on-demand webinar here: https://bit.ly/35Pfyik
Tufts Research: EDC Trends, Insights, and OpportunitiesVeeva Systems
Watch the video here: https://bit.ly/3yIrVu0
New Tufts research on the eClinical landscape
Learn how seemingly minor decisions in one functional group can significantly impact overall clinical trial timelines. Specifically, those who never release the database before first patient, first visit (FPFV) take more than three weeks longer to lock the database than those who always release before FPFV. Other key findings include:
* Types and volume of data companies manage in EDC
* The biggest causes of database build delays
* How sponsor and CRO cycle times compare for database build, data entry, and database lock
Who Will Benefit:
* Data Management
* eClinical
* Clinical Operations
* Biometrics
* Clinical Development
* R&D IT
Webinar: Rethinking the Life Sciences Training Technology EcosystemVeeva Systems
Watch the full webinar here: https://go.veeva.com/training-ecosystem-2021
As a training steward, you are required to select the right systems to enable an effective and efficient training program for your organization. But the task is easier said than done due to an increasingly complex technology landscape.
Join Kent Malmros, Sr. Director of Veeva Vault Training, to learn about different training technologies available today and how they fit together to create an optimal learning environment for both administrators and learners. You will also learn about technologies you won't need, reducing the cost and complexity of your training environment.
In this one hour webinar, you will learn:
Key definitions and descriptions of modern training technology categories
How to prioritize acquiring new job technologies and eliminating legacy solutions
Best practices for effectively connecting systems and processes to ensure faster time to qualification and competency
We will also have a deep dive discussion into:
Authoring tools
Document and Content Management Systems
Learning Management Systems
Gamification Frameworks
Learning Experience Platforms
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).
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.
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.
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
The Benefits of a Seamless IRT and EDC Integration in Clinical Trial ExecutionVeeva Systems
Watch the video here: https://bit.ly/3upehbN
Veeva and Suvoda have combined their offerings into a powerful streamlined integration, which accommodates advanced study designs while driving down build and casebook complexity.
Hear Catherine Munera, head of biometrics at Cara Therapeutics, share the benefits of moving from a single provider to taking a harmonized, best-of-breed approach with IRT and EDC.
Unify quality manufacturing to drive speed, compliance and collaborationVeeva Systems
Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.
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.
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.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
Clinlogix - Improving Pharmacovigilance Outsourcing with Modern Technologies Veeva Systems
Learn how pharma companies and vendors are collaborating and simplifying processes with modern safety solutions. View the on-demand webinar here: https://bit.ly/30eAlJC
University of Louisville: Enabling Research During COVID-19 and BeyondVeeva Systems
The University of Louisville shares how they adapted their operations in the midst of the COVID-19 pandemic to keep research moving forward. Watch the full presentation at https://bit.ly/UofLResearch.
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
Climate Science Flows: Enabling Petabyte-Scale Climate Analysis with the Eart...Globus
The Earth System Grid Federation (ESGF) is a global network of data servers that archives and distributes the planet’s largest collection of Earth system model output for thousands of climate and environmental scientists worldwide. Many of these petabyte-scale data archives are located in proximity to large high-performance computing (HPC) or cloud computing resources, but the primary workflow for data users consists of transferring data, and applying computations on a different system. As a part of the ESGF 2.0 US project (funded by the United States Department of Energy Office of Science), we developed pre-defined data workflows, which can be run on-demand, capable of applying many data reduction and data analysis to the large ESGF data archives, transferring only the resultant analysis (ex. visualizations, smaller data files). In this talk, we will showcase a few of these workflows, highlighting how Globus Flows can be used for petabyte-scale climate analysis.
Multiple Your Crypto Portfolio with the Innovative Features of Advanced Crypt...Hivelance Technology
Cryptocurrency trading bots are computer programs designed to automate buying, selling, and managing cryptocurrency transactions. These bots utilize advanced algorithms and machine learning techniques to analyze market data, identify trading opportunities, and execute trades on behalf of their users. By automating the decision-making process, crypto trading bots can react to market changes faster than human traders
Hivelance, a leading provider of cryptocurrency trading bot development services, stands out as the premier choice for crypto traders and developers. Hivelance boasts a team of seasoned cryptocurrency experts and software engineers who deeply understand the crypto market and the latest trends in automated trading, Hivelance leverages the latest technologies and tools in the industry, including advanced AI and machine learning algorithms, to create highly efficient and adaptable crypto trading bots
How Recreation Management Software Can Streamline Your Operations.pptxwottaspaceseo
Recreation management software streamlines operations by automating key tasks such as scheduling, registration, and payment processing, reducing manual workload and errors. It provides centralized management of facilities, classes, and events, ensuring efficient resource allocation and facility usage. The software offers user-friendly online portals for easy access to bookings and program information, enhancing customer experience. Real-time reporting and data analytics deliver insights into attendance and preferences, aiding in strategic decision-making. Additionally, effective communication tools keep participants and staff informed with timely updates. Overall, recreation management software enhances efficiency, improves service delivery, and boosts customer satisfaction.
In 2015, I used to write extensions for Joomla, WordPress, phpBB3, etc and I ...Juraj Vysvader
In 2015, I used to write extensions for Joomla, WordPress, phpBB3, etc and I didn't get rich from it but it did have 63K downloads (powered possible tens of thousands of websites).
Understanding Globus Data Transfers with NetSageGlobus
NetSage is an open privacy-aware network measurement, analysis, and visualization service designed to help end-users visualize and reason about large data transfers. NetSage traditionally has used a combination of passive measurements, including SNMP and flow data, as well as active measurements, mainly perfSONAR, to provide longitudinal network performance data visualization. It has been deployed by dozens of networks world wide, and is supported domestically by the Engagement and Performance Operations Center (EPOC), NSF #2328479. We have recently expanded the NetSage data sources to include logs for Globus data transfers, following the same privacy-preserving approach as for Flow data. Using the logs for the Texas Advanced Computing Center (TACC) as an example, this talk will walk through several different example use cases that NetSage can answer, including: Who is using Globus to share data with my institution, and what kind of performance are they able to achieve? How many transfers has Globus supported for us? Which sites are we sharing the most data with, and how is that changing over time? How is my site using Globus to move data internally, and what kind of performance do we see for those transfers? What percentage of data transfers at my institution used Globus, and how did the overall data transfer performance compare to the Globus users?
Code reviews are vital for ensuring good code quality. They serve as one of our last lines of defense against bugs and subpar code reaching production.
Yet, they often turn into annoying tasks riddled with frustration, hostility, unclear feedback and lack of standards. How can we improve this crucial process?
In this session we will cover:
- The Art of Effective Code Reviews
- Streamlining the Review Process
- Elevating Reviews with Automated Tools
By the end of this presentation, you'll have the knowledge on how to organize and improve your code review proces
Globus Connect Server Deep Dive - GlobusWorld 2024Globus
We explore the Globus Connect Server (GCS) architecture and experiment with advanced configuration options and use cases. This content is targeted at system administrators who are familiar with GCS and currently operate—or are planning to operate—broader deployments at their institution.
Cyaniclab : Software Development Agency Portfolio.pdfCyanic lab
CyanicLab, an offshore custom software development company based in Sweden,India, Finland, is your go-to partner for startup development and innovative web design solutions. Our expert team specializes in crafting cutting-edge software tailored to meet the unique needs of startups and established enterprises alike. From conceptualization to execution, we offer comprehensive services including web and mobile app development, UI/UX design, and ongoing software maintenance. Ready to elevate your business? Contact CyanicLab today and let us propel your vision to success with our top-notch IT solutions.
Exploring Innovations in Data Repository Solutions - Insights from the U.S. G...Globus
The U.S. Geological Survey (USGS) has made substantial investments in meeting evolving scientific, technical, and policy driven demands on storing, managing, and delivering data. As these demands continue to grow in complexity and scale, the USGS must continue to explore innovative solutions to improve its management, curation, sharing, delivering, and preservation approaches for large-scale research data. Supporting these needs, the USGS has partnered with the University of Chicago-Globus to research and develop advanced repository components and workflows leveraging its current investment in Globus. The primary outcome of this partnership includes the development of a prototype enterprise repository, driven by USGS Data Release requirements, through exploration and implementation of the entire suite of the Globus platform offerings, including Globus Flow, Globus Auth, Globus Transfer, and Globus Search. This presentation will provide insights into this research partnership, introduce the unique requirements and challenges being addressed and provide relevant project progress.
Listen to the keynote address and hear about the latest developments from Rachana Ananthakrishnan and Ian Foster who review the updates to the Globus Platform and Service, and the relevance of Globus to the scientific community as an automation platform to accelerate scientific discovery.
Paketo Buildpacks : la meilleure façon de construire des images OCI? DevopsDa...Anthony Dahanne
Les Buildpacks existent depuis plus de 10 ans ! D’abord, ils étaient utilisés pour détecter et construire une application avant de la déployer sur certains PaaS. Ensuite, nous avons pu créer des images Docker (OCI) avec leur dernière génération, les Cloud Native Buildpacks (CNCF en incubation). Sont-ils une bonne alternative au Dockerfile ? Que sont les buildpacks Paketo ? Quelles communautés les soutiennent et comment ?
Venez le découvrir lors de cette session ignite
Into the Box Keynote Day 2: Unveiling amazing updates and announcements for modern CFML developers! Get ready for exciting releases and updates on Ortus tools and products. Stay tuned for cutting-edge innovations designed to boost your productivity.
Your Digital Assistant.
Making complex approach simple. Straightforward process saves time. No more waiting to connect with people that matter to you. Safety first is not a cliché - Securely protect information in cloud storage to prevent any third party from accessing data.
Would you rather make your visitors feel burdened by making them wait? Or choose VizMan for a stress-free experience? VizMan is an automated visitor management system that works for any industries not limited to factories, societies, government institutes, and warehouses. A new age contactless way of logging information of visitors, employees, packages, and vehicles. VizMan is a digital logbook so it deters unnecessary use of paper or space since there is no requirement of bundles of registers that is left to collect dust in a corner of a room. Visitor’s essential details, helps in scheduling meetings for visitors and employees, and assists in supervising the attendance of the employees. With VizMan, visitors don’t need to wait for hours in long queues. VizMan handles visitors with the value they deserve because we know time is important to you.
Feasible Features
One Subscription, Four Modules – Admin, Employee, Receptionist, and Gatekeeper ensures confidentiality and prevents data from being manipulated
User Friendly – can be easily used on Android, iOS, and Web Interface
Multiple Accessibility – Log in through any device from any place at any time
One app for all industries – a Visitor Management System that works for any organisation.
Stress-free Sign-up
Visitor is registered and checked-in by the Receptionist
Host gets a notification, where they opt to Approve the meeting
Host notifies the Receptionist of the end of the meeting
Visitor is checked-out by the Receptionist
Host enters notes and remarks of the meeting
Customizable Components
Scheduling Meetings – Host can invite visitors for meetings and also approve, reject and reschedule meetings
Single/Bulk invites – Invitations can be sent individually to a visitor or collectively to many visitors
VIP Visitors – Additional security of data for VIP visitors to avoid misuse of information
Courier Management – Keeps a check on deliveries like commodities being delivered in and out of establishments
Alerts & Notifications – Get notified on SMS, email, and application
Parking Management – Manage availability of parking space
Individual log-in – Every user has their own log-in id
Visitor/Meeting Analytics – Evaluate notes and remarks of the meeting stored in the system
Visitor Management System is a secure and user friendly database manager that records, filters, tracks the visitors to your organization.
"Secure Your Premises with VizMan (VMS) – Get It Now"
Prosigns: Transforming Business with Tailored Technology SolutionsProsigns
Unlocking Business Potential: Tailored Technology Solutions by Prosigns
Discover how Prosigns, a leading technology solutions provider, partners with businesses to drive innovation and success. Our presentation showcases our comprehensive range of services, including custom software development, web and mobile app development, AI & ML solutions, blockchain integration, DevOps services, and Microsoft Dynamics 365 support.
Custom Software Development: Prosigns specializes in creating bespoke software solutions that cater to your unique business needs. Our team of experts works closely with you to understand your requirements and deliver tailor-made software that enhances efficiency and drives growth.
Web and Mobile App Development: From responsive websites to intuitive mobile applications, Prosigns develops cutting-edge solutions that engage users and deliver seamless experiences across devices.
AI & ML Solutions: Harnessing the power of Artificial Intelligence and Machine Learning, Prosigns provides smart solutions that automate processes, provide valuable insights, and drive informed decision-making.
Blockchain Integration: Prosigns offers comprehensive blockchain solutions, including development, integration, and consulting services, enabling businesses to leverage blockchain technology for enhanced security, transparency, and efficiency.
DevOps Services: Prosigns' DevOps services streamline development and operations processes, ensuring faster and more reliable software delivery through automation and continuous integration.
Microsoft Dynamics 365 Support: Prosigns provides comprehensive support and maintenance services for Microsoft Dynamics 365, ensuring your system is always up-to-date, secure, and running smoothly.
Learn how our collaborative approach and dedication to excellence help businesses achieve their goals and stay ahead in today's digital landscape. From concept to deployment, Prosigns is your trusted partner for transforming ideas into reality and unlocking the full potential of your business.
Join us on a journey of innovation and growth. Let's partner for success with Prosigns.
Strategies for Successful Data Migration Tools.pptxvarshanayak241
Data migration is a complex but essential task for organizations aiming to modernize their IT infrastructure and leverage new technologies. By understanding common challenges and implementing these strategies, businesses can achieve a successful migration with minimal disruption. Data Migration Tool like Ask On Data play a pivotal role in this journey, offering features that streamline the process, ensure data integrity, and maintain security. With the right approach and tools, organizations can turn the challenge of data migration into an opportunity for growth and innovation.
Field Employee Tracking System| MiTrack App| Best Employee Tracking Solution|...informapgpstrackings
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18. Idorsia Today
>750Highly qualified
professionals
10
>1 bn > 550State-of-the-art
laboratory workspaces
Compounds in the pipeline,
with four in late-stage
development
Swiss francs in cash
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Multiple therapeutic areas
CNS
Cardiovascular
Immunological disorders
Orphan diseases
19. Legacy Systems Landscape
Idorsia
A “green field” with great time pressure and fixed deadline
Transition Agreements (12
months)
A Unique Opportunity
Project & Resource Management
Business & Corporate Systems
Infrastructure & User Support
eTMF CTMS
eCTDEDMS
EDC
Statistical
Computing
Environment
Data Analytics
QMS
Clinical Trial
Portal
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20. Platform based and SaaS
The Strategy
Clinical & Quality Systems Scope
Document Management
Quality Management
Project & Resource Management
Clinical
Operations
Clinical
Data
Regulatory &
Submissions
CTMS & eTMF
QMS
EDMS
EDMS & eCTD
Functionality and Usability
• Best fit to Idorsia user requirements
• Minimal configuration no customization
• User-friendly and intuitive
• Connecting information in R&D
Idorsia‘s IT strategy
• One platform supporting a variety of functional areas
• True Software as a Service
• Compliant
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21. Making the impossible happen
Our Journey’s Timeline and Scope
2017 2018 2019
J A S O N D J F M A M J J A S O N D J F M
Program & Change Management
Platform
CTMS & eTMF (Clinical)
EDMS (Regulatory & Quality)
QMS (Quality Management)
OtherClinical
eCTD System
Biometry Environment
Data Analytics Platform & Tools
Project & Resource Management System
Drug Safety Systems
Other
Business & Corporate Systems
Infrastructure & User Support
Kick-off WS to go-live Ongoing
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22. A unified solution
Highlights and User Experience
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23. CTMS
• 180 users
• 6 ongoing and all legacy
studies
eTMF
• 180 users
• 6 closed studies
EDMS
• 300 users
• 50.000 documents
Implementation & roll-out
Benefits Of The Unified Platform
Scope Highlights
Streamlined approach to validation documentation, testing, operational
procedures
Minimal integration effort
• Integrated eTMF/ CTMS, no technical interfaces required to align milestones
or transfer documents
• User provisioning/ SSO set up on platform level
Experience can be applied across all
applications
MAR
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24. End User Experience
Benefits Of The Unified Platform
Highlights
Ease of use
• Same user interface and principles across all application
• Ease of navigation and search functionality (filters and views)
• Visual representation of documents and metadata in one view
Seamless use of CTMS and eTMF, e.g.
• Studies, sites, personnel only created once
• Monitoring Visit Reports signed in CTMS and automatically in eTMF
• Comprehensive progress reporting
Cross-linking of documents between
eTMF and EDMS
Clinical Trial Management System
(CTMS)
Electronic Trial Master File (eTMF)
Electronic Document Management
System (eEDMS)
Scope Highlights
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25. Maintenance and Support
Benefits Of The Unified Platform
CTMS/ eTMF
• 310 users
• 14 ongoing studies
(w/o phase 1)
EDMS
• 300 users
Reduced training effort
• Users get quickly up to speed if trained on one of the Vaults
• CRAs - 3 hours, Study Managers - 2.5 hours (eTMF and CTMS)
Small support team working across the platform
Streamlined release management
• 3 major releases per year which can be run “silent”
• New functionality implemented at own pace
per application
Streamlined vendor and contract management
HighlightsScope
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26. • Strong dependency on one vendor requires solid risk assessment and a strategic partnership
• Not all applications may be “best of breed”
• Software as a service / cloud based
- To be in line with the corporate IT strategy
- Requires streamlined business processes adapted to the system to avoid customization
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Considerations!!
27. Document Management
Quality Management
Project & Resource Management
Clinical
Operations
Clinical
Data
Regulatory &
Submissions
CTMS & eTMF
QMS
EDMS
EDMS & eCTD
Summary
User Experience
Implementation & Roll-out
Maintenance & Support
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