Future of eTMF Webinar - Montrium
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The way we manage the TMF is constantly evolving. Regulations are often catalysts to change in the eTMF space and staying on top of industry trends is vital in making sure you are working in the best possible way. In our presentation, we will be exploring 5 of the hottest trends in the future of eTMF which include interoperability, traceability and data integrity, challenges of inspection when data is spread in multiple systems, and how the industry would be affected by the potential ratification of the TMF Reference Model by ICH. We will also dive deeper into the inner workings of these trends and how we can begin to solve some of these issues which are spreading in the industry. The presentation covers the following topics: - Where the industry is today regarding eTMF - What regulatory bodies are initiating change in the clinical space - How the ICH is a catalyst to change in the TMF reference model - Traceability and data integrity in today's model - Challenges of inspection with disparate systems - Interoperability and the future of eTMF - Plus much more... Follow along via our webinar: https://info.montrium.com/the-future-of-etmf-actionable-industry-trends-and-insights
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Future of eTMF Webinar - Montrium
- 2. The Future of eTMF: Actionable Industry Trends and Insights eTMF Bootcamp Webinar Series Thursday, 6 December 2018 2
- 3. 3 Today’s Agenda LIVE WEBINAR • About Montrium • Where we are today with eTMF • What are we missing? • What the future holds...
- 5. 5 House Keeping L I V E W E B I N A R • This webinar is being recorded and will be made available after this session • Feel free to use the chatbox to submit your questions at anytime • Q&A will take place at the end of the webinar • We will send these slides to your email at the end of the webinar
- 7. • Founded in 2005 • Working Exclusively in the Life Sciences • Headquartered in Montreal, Canada • EU HQ in Luxembourg • Clients in North America, Europe & Asia • Leading Content Management Platform • Over 8000 Users in 20+ Countries • Experienced Professional Services Group 7 About Montrium Connecting People, Processes & Technology A B O U T T H E C O M P A N Y
- 8. 8 Electronic Content Management & Business Intelligence for Clinical Trials C O N N E C T P L A T F O R M Regulatory Document Management & Submission Planning for Drugs and Devices Integrated and Data Driven Quality Management Solutions for Life Sciences
- 10. eTMF adoption is progressing but… • eTMF is still considered a repository/archive • Information is often unstructured • TMF completeness is still guesswork • We still have paper and paper approaches • Systems are not interconnected • TMF management tends to be decentralized and passive 10 Where we are today …This makes telling the story difficult
- 11. Simple things should be simple, complex things should be POSSIBLE. The perfect project plan is POSSIBLE if one first documents a list of ALL the UNKNOWNS. - Bill Langley 11
- 12. What are we missing? • Truly collaborative systems • Structured information and data, not just documents • Predictive completeness • Integrated internal and external systems representing a comprehensive and holistic TMF • Process and activity-based viewing • Ability to eradicate paper • Proactive, centralized approaches to eTMF management and oversight
- 13. Amsterdam’s Trial Master File & Inspection Readiness Conference (September, 2018) “Our Perfect TMF” brainstorming exercise 13 Industry Insights
- 14. 14
- 16. 16 Other notable requirements • Automated templates • Automated storyboards • ISF and eTMF integration • KPI indicator flags • Mobile apps for scanning/upload • Interactive timeline and process flow • Document recognition (auto-filing) • Artificial intelligence/machine learning capabilities
- 17. What does the future hold..... 17
- 18. • Adoption of eTMF systems increasing with each year • Expectations of inspectors - New EU guidance on eTMF • Increased scrutiny • Focus on data integrity • Emerging technologies and predictive analysis • Desire to leverage AI / Machine Learning 18 Things are changing
- 19. Predictive completeness § Completeness today is far from accurate § To calculate accurate completeness we need information § By taking a process modeling approach to TMF coupled with system integration we can improve things § Process modelling allows for the generation of placeholders based on expected processes, event and artifacts § Processes are triggered from underlying data sources § Machine learning could be used to continuously improve on this
- 21. • Today’s eTMF systems organize content based on the reference model • It is difficult to reconstruct events using the RM • Clinical process models will allow better visualizations of specific processes • Artifacts are clustered around these models • Processes are triggered from events • Significantly improve the telling of the story during inspections 21A B O U T T H E C O M P A N Y Process-based visualizations
- 22. 22
- 23. 23 Interchange and Integration – Current State of Affairs IRBs Partners Vendors Labs Sites CROs SPONSOR
- 24. Interchange and Integration Problems • Many clinical trial activities are outsourced • There is often multiple eTMF systems being used for a single clinical trial • Other eClinical systems are also TMF relevant • This creates a lot of different information sources.... • ….and often a lot of shadow copies • Inspections are significantly more complex
- 25. Interchange and Integration in the future • The eTMF-EMS standard should significantly help improve interchange of content and metadata between systems • The eTMF-EMS is built to allow automated exchange • It will evolve to exchange content not just between eTMF systems, but all clinical systems that hold TMF relevant content • In the future we will see a master or meta eTMF tool which is capable of centralizing content from all source systems • eTMF-EMS will certainly contribute however more standardization is required regarding TMF content and process mapping
- 26. Introducing Meta-eTMF § Today, our TMF information is in multiple locations § These locations can be internal or external to the sponsor organizations § Not just eTMF systems § Meta-eTMF is a visualization layer which allows the rollup of content from multiple underlying repositories § Allows for one interface to present a holistic eTMF § Simplifies inspections and access to information § Provides complete metrics for studies and across studies
- 27. • Inspectors require direct access to systems that contain TMF content • Building systems that can track inspector activity is key to understanding inspector activity • Remote access is becoming a reality and so we need better tools to manage remote inspections • We should correlate findings with inspector activity to gain better understanding of what was reviewed and how findings were qualified 27 Inspection tracking and trending
- 28. • In the future we will move more and more to structured content • More documents will transform into electronic data capture • We will see the emergence of more data standards for TMF content • TMF will be composed more and more of data from other systems • We will see significant improvements in automated QC and indexing of content through AI and machine learning 28A B O U T T H E C O M P A N Y Documents are data
- 29. Risk-based eTMF § Risk based approach is a de facto requirement for conducting clinical trials § There is strong case for applying risk management to TMF § Risk scoring could be implemented at different levels to identify inspection risk § Machine learning can be leveraged combined with inspection tracking to improve risk scoring algorithms § As the TMF becomes more data centric and data rich, risk scoring could evolve to identify clinical risks
- 30. eTMF Data Management • We need to change the way we think about TMF management • It should NOT be considered simply an archiving function • We should be proactively managing the content through automated verifications and review • We need to employ techniques used in clinical data management to detect anomalies • We need to introduce more intelligence to our eTMF toolset by leveraging our process models • We need to leverage operational data from other systems to be able to run completeness and health checks on our TMF
- 31. Improved inspection readiness Inspection readiness means that: • The TMF is complete and provides easy access to all study information • There are no anomalies with the TMF or that anomalies have been adequately explained through notes to file • The inspector has access to all content in all repositories • The TMF can be navigated in an intuitive way which allows study events to be understood easily and all associated content is readily available • Any TMF risks have been identified and mitigated
- 32. Key Takeaways from Today’s Webinar • Today information is often unstructured, and completeness is very much guess work – this will change through a more integrated system approach • We need to change our approach to TMF management – we should inspire ourselves with clinical data management techniques • We need to rethink how information is presented – it is easier to tell the story through processed based modelling • Integration of eTMF systems into one central meta-eTMF will permit proactive approach to management and oversight • Documents will become data and eTMF will become a reporting tool
- 33. Which of these eTMF trends would you like to see a webinar on in 2019? a) Risk-Based Approach to eTMF Planning b) Documents Are Data – Predictive Analysis with Emerging Tech c) Interchange and Integration Between eClinical Systems (meta-eTMF) d) Process-based TMF e) Applying clinical data-management techniques to eTMF management 33 POLL
- 34. Follow industry influencers - Network with thought leaders from clinical, IT, operations, sponsors, CROS, regulatory orgs Attend top conferences in your industry (clinical, regulatory, IT) Stay updated with technological and regulatory news - TMF Reference Model News - Montrium’s “Stay Connected” blog 34 A few way to stay in the loop on future developments 1 2 3
- 35. 35 • Facilitate exchange of clinical trial information to all stakeholders • Accurately track the progress of TMF completeness • Quickly comply with regulatory requirements, audits and inspections An intuitive eTMF Platform Engineered for Growth Organizations
- 36. Are you interested in receiving more information about Montrium’s eTMF Connect? 1) Yes, could be useful 2) No, not interested 36 POLL
- 37. QUESTIONS? 37
- 38. INFO@MONTRIUM.COM Thank You! & Happy Holidays from Montrium