It is a key concern for both software vendors and sponsors that there is a fundamental alignment between the TMF Reference Model, which is in place in the large majority of eTMF implementations, and the OASIS eTMF Model to ensure that the interoperability standard can be achieved AND maintained. This requires compromise and communication across both models, as the interest is
As we have seen with the research done around eCTD, interoperability is a huge challenge and presents extreme risk for many sponsors when considering content or technology transfers.
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Bryan Ennis
Director of R&D Customer Success
Save the date for the Veeva R&D Summit October 21-22, 2014