Dear Oasis,
We believe that any interoperability standard for eTMF should begin with the work of the DIA Reference Model as many companies have built their TMF structure around it.
The Oasis initiative has not gone down that route and appears is focused on detailed technical specifications without first aligning with the business requirements.
Regards,
Andrew
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Andrew Mitchell Director of
Strategy & Product Marketing (Life Sciences) M +44 7841-000-427 Intralinks Inc. 4th Floor, The Rex Building, 62 Queen Street, London, EC4R 1EB
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