Electronic Trial Masterfile (eTMF)
Frustrated eTMF Users
Many biopharma companies are struggling with eTMF these days. They want a simple, practical solution but can’t find one, leading to frustrated users. Alternatively, many sponsor companies let CROs manage their eTMFs. This can be risky given how much health authorities are emphasizing CRO oversight these days. Plus, there’s the added complication of getting the TMF documents from your CRO. Either way, the result is the same: users wanting to bang their heads against the wall while keeping track of dozens of critical study documents.
At Intrinsic, our eTMF solution is built on the SharePoint platform and boasts a user interface that everyone is instantly familiar with. Utilizing the DIA eTMF reference model, Intrinsic eTMF provides a practical and secure way of quickly tagging documents. And sites will no longer have to remember yet another user name and password—instead of logging into the system, they simply email documents to a study-specific email address, from which the document gets uploaded automatically into the eTMF while sponsor or CRO personnel receive an alert. No site training required!
Built for the Way You Work
Intrinsic is built on the same Microsoft platform that millions use every day. Our suite of clinical software is built on Office 365, so biotech companies benefit from a cloud-based, robust, and scalable infrastructure. Users enjoy the benefits of document collaboration for their eTMF, CTMS, or study portal while using SharePoint. Between the plethora of native Microsoft features and the familiarity, users have with the platform, user adoption of Intrinsic tools is never a problem.