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Friday, February 7, 2020 | 5:41 PM
If you were working in clinical trials in the early 2000s, you got to witness the first adaptation of technologies going paperless. As we have now rolled into the 2020s, we see innovation across the entire lifecycle and the addition of artificial intelligence and machine learning to automate insights and processes. Many companies have been on this journey with Trial Interactive for over a decade. Whether or not you have joined us yet, here’s a little bit of what 2020 looks like for the Trial Interactive clinical community:
TI10 (eTMF and Platform Updates) – Clinical teams kicked off this year with the release of version 10.0 of our e-clinical platform, TI10. There is a complete refresh of the user experience along with major platform updates that include a fully featured clinical document collaboration and management experience that flows seamlessly to both the eTMF and LMS. Other powerful additions, such as ML-powered document classification, mobile CRA reconciliation, and highly configurable and actionable metrics, make this version of Trial Interactive an important release for study teams around the world.
With TI10, study teams execute a true enterprise strategy for inspection readiness that begins with the creation of any document and maintains a single history for all clinical documentation through its ultimate approval and indexing in the eTMF. 2020 is the year of the author-to-archive platform, which includes…
Document Management and Clinical Training – The QA side of clinical trials necessitates document control and versioning to ensure documents are executed appropriately and the most current version of SOPs or policies are in effect. Another reason why 2020 emphasizes the author-to-archive experience is the importance of the flow of document management to training relevant study personnel. Organizations of any size, from a start-up drafting its first-ever SOW to experienced large pharma or medical device companies, can make great strides in quality and overall inspection readiness by formalizing this document flow and automatically distributing training to the right people, ultimately documenting all training in the eTMF. An essential part of the document management experience is…
Collaboration – Regulatory agencies are adjusting their expectations with the advances in technology. With the ability to maintain continuous audit trails, it should come as no surprise that some agencies are beginning to look at full document histories, including the authoring, review, and approval trail before indexing in the eTMF. While there is debate about whether this level of scrutiny is necessary, study teams still need to account for the emerging consideration.
Offering 21 CFR Part 11 compliant collaborative authoring gives study teams peace of mind. Documents can go from collaboration and approval directly to the eTMF, so regulatory agencies can readily access this history upon request. This audit trail requirement reinforces the importance of an author-to-archive experience, which will continue to see expansions and advancements throughout the year. Additional capability for global studies to identify and automatically submit documentation for translation creates even more efficiency in site activation.
Finally, to complete the author-to-archive theme, we will roll out the oversight clinical teams need with a…
Clinical Trial Management System (CTMS) – These systems have historically been plagued by issues ranging from being too complicated (even for “power users”) to lacking in key functionality. Trial Interactive clients have requested a solution, and it will be so. The mobile-first solution will feature intuitive, configurable dashboards to put important information at the fingertips of study teams to make rapid decisions and complete required activities. Many small to mid-sized organizations get left out of the innovation rush, so we are taking measures to ensure an accessible and easy-to-implement CTMS.
You may have heard our team use the phrase “by clinical for clinical.” All of the above updates have been driven by our community of engaged power users and clinical leaders. For more detailed information about our roadmap or how sponsors and CROs are leveraging an author-to-archive approach, contact us at info@trialinteractive.com.
