CDISC EU Interchange 2024 has concluded and this year we were offered a treasure trove of insights and innovations. The TMF Reference Model’s inclusion in CDISC has further solidified the driving trend of data standardization and interoperability of TMFs. While I enjoyed presenting with Arkivum’s Matthew Addis and seeing fellow JiT representative Carol Radwanski present with inSeption Group’s Dawn Niccum, the reality is that our presentations represented a small sample of the vast expanse of information there was to learn. With several tracks available and multiple sessions running in parallel, I wanted to share my key takeaways from this year’s CDISC EU Interchange.
- Automation Revolution: Automation has emerged as a game-changer in TMF management from automated document classification to intelligent workflows, technology has accelerated processes while minimizing errors. This year, we are going a step further! AI and ML is continuing to advance and is beginning to look at things across systems and dataflows to provide a new level of data insights and searchability. As part of the final session, the group was prompted with thought provoking questions like “would you let your AI respond directly to questions from an Inspector/Auditor?” which resulted in a great industry discussion around treating AI like a person.
- Harmonization is Key: The importance of harmonizing TMF standards and data across the industry is no longer just a desire of many, but a need in order to further leverage our rapidly advancing technology. While consistency clearly streamlines regulatory compliance it can also enhances data integrity and interoperability. The TMF Exchange Mechanism is available for all organizations, we just need to adopt it. This will allow for far simpler migrations of data as well as powering-up integrations by getting systems speaking in the same language.
- TMF is a Culture: Effective collaboration among stakeholders is pivotal in TMF management. Whether it’s internal or external, fostering a strong TMF culture is critical for empowering your system and process. TMF culture is far more than just organizations communicating and collaborating on the TMF, it involves getting buy-in to the value of the TMF as a living tool and not just the place where essential documents go to die. It was great to hear from so many industry experts about how organizations can build a strong TMF culture within their own organization and getting their senior leaders and functional areas to champion the TMF.
- Risk Based Approaches: Regulatory compliance remains a cornerstone of TMF management but navigating the labyrinth of regulations, such as the ICH E6(R3) draft, often demands meticulous planning, robust processes, and unwavering adherence to standards. The TMF Keynote presentation by Dr. Torsten Stemmler of BfArM offered us an incredible insight into an Inspector’s view of the importance of the TMF and how risk based approaches can be interpreted. This served as not just a great way to kick off the conference but a real discussion point throughout the conference. One of the most valuable things I took from his presentation was the idea that risk based does not automatically equate to less work. Taking a risk based approach may mean that we are performing deeper and more expansive reviews until we can prove that we can decrease the scope without introducing further risk.
Looking ahead, the TMF landscape is poised for further evolution. With advancements in artificial intelligence, machine learning, and blockchain, the future promises innovations that will revolutionize TMF management, ushering in an era of enhanced efficiency, transparency, and compliance. It is on all of us Sponsors, CROs, and Vendors to hold each other to standards and push the industry towards an expectation of interconnectivity. Within our organizations, we must further the narrative of the TMF as the area where work gets done (and therefore immediately filed), rather than the area everyone rushes to get their documents in at the end of the study.
~Jim Markley, Associate Director, Consulting
