Model 1: Best practices to leverage CRO eTMF<\/h2>\n
One operating model involves CROs owning and managing the eTMF. KCR is a mid-sized CRO that encourages work in their own eTMF Vault. The reasons for this approach are that:<\/p>\n
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- Vault eTMF is unified with Vault CTMS and connected with Vault EDC and other systems<\/li>\n
- Study teams are trained on their internal systems and processes<\/li>\n
- They have a monthly cadence for software and training updates<\/li>\n<\/ul>\n
\u201cVault eTMF and Vault CTMS work very well together,\u201d said Doug Bain, KCR\u2019s chief technology officer. \u201cWe see great benefits \u2014 for example, our monitoring reports are automatically populated and delivered from the CTMS into the eTMF.\u201d<\/p>\n
KCR enables sponsor oversight by providing sponsors access to their eTMF and maintaining granular reports and dashboards on metrics like completeness. Teams are more effective when working within their own processes and systems, recording a higher completeness metric of 97%, compared to 91% when working in sponsor systems. Sponsor-only documents can also be blinded in KCR\u2019s system. <\/p>\n
\nAssessing Completeness Across Systems<\/strong>\n<\/div>\n\n![\"Blog](\"https:\/\/www.veeva.com\/eu\/wp-content\/uploads\/2022\/08\/Blog-Graphics-1.png\")
<\/a>\n<\/div>\nAt the end of studies with sponsors that also have Vault eTMF, KCR can use the validated process through TMF Transfer<\/a> to transfer TMF documents quickly and accurately and eliminate end-of-study migrations.<\/p>\n
When leveraging CRO systems, sponsors should consider: <\/p>\n
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- Where to store sponsor-owned documents, such as RFPs, internal SOPs, and oversight materials<\/li>\n
- Which measures CROs provide for oversight, such as direct sponsor access and regular reports<\/li>\n
- What migration strategy to use at the end of the study<\/li>\n<\/ul>\n
Best practices for sponsor-owned eTMF<\/h2>\n
Other operating models involve sponsors owning an eTMF, either for sponsor documents or for the study as a whole.<\/p>\n
Model 2: Sponsor and CRO eTMFs<\/h3>\n
Alvotech is a global biopharmaceutical company and maintains Vault eTMF for sponsor documents. Their CRO partners are responsible for migrating the TMF to them at the end of the study, where they can then archive it. Alvotech implemented this system to replace a paper filing system and improve inspection readiness, as well as enable CRO partners to continue working into their own systems.<\/p>\n
\u201cA CRO generally has its own systems and SOPs geared toward their processes,\u201d said Ruth Ruffieux, Alvotech\u2019s head of clinical operations. \u201cAs a small biotech, it’s difficult to ask a big or mid-size CRO to stop doing what they’re doing and work in our system \u2014 and that was one of the main reasons why we selected this model. It’s a good starting point for growing biotechs.\u201d<\/p>\n
\nBenefits of Sponsor and CRO eTMFs<\/strong>\n<\/div>\n\n![\"Blog](\"https:\/\/www.veeva.com\/eu\/wp-content\/uploads\/2022\/08\/Blog-Graphics-2.png\")
<\/a>\n<\/div>\nModel 3: Sponsor uses in-house eTMF<\/h3>\n
argenx, a global biopharmaceutical company, is evaluating its long-term strategy to have CROs work into its sponsor-owned Vault eTMF. As the clinical trial volume and number of CRO partners have increased (they are currently running 30 trials), they are now evaluating this model to ensure a single source of truth.<\/p>\n
\u201cIn recent inspections, it could take us up to four hours to get a document because we would need to identify where it was stored and whether we had direct access,\u201d said Melissa De Swaef, argenx\u2019s head of clinical operations processes and systems. \u201cWe hope to eliminate these steps with a single source of truth and CRO access, as well as streamline operations with the TMF Index functionality to simplify navigation of our eTMF.\u201d<\/p>\n
If the company rolls out this model to all trials, it predicts a five-year 100% return on investment due to eliminating end-of-study migrations, reducing audit and inspection preparation time, and managing documents more effectively across parties.<\/p>\n
![\"Blog](\"https:\/\/www.veeva.com\/eu\/wp-content\/uploads\/2022\/08\/Blog-Graphics-3.png\")
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