eTMF Vendor Outreach Initiated

The TMF Reference Model Project have initiated a program to reach out to the eTMF vendor community to get input into a key subject which is generating a lot of discussion at the moment – eTMF interoperability. There was some initial work done on interoperability within the reference model subcommittees and more recently we have seen the launch of an eTMF standard Technical Committee initiative within OASIS. Experience has shown that vendors play a key role in the adoption and implementation of any interoperability standard and we wanted to specifically solicit vendor feedback and thoughts on the best path forward.


In our opinion, there are several paths that the vendor community could follow, notably:


  • Join the OASIS Technical Committee to participate in the development of the eTMF interoperability standard and then adopt the standard fully or partially once released;
  • Adopt the OASIS standard fully or partially once it is released without participation in the OASIS Technical Committee;
  • Develop a vendor-initiated standard and find a standards body to manage it in collaboration with the TMF Reference model interoperability sub-committee;
  • Take no action and let interoperability evolve naturally; or
  • Other paths that have not yet been explored / proposed 

One thing is clear, as more and more sponsors and CROs adopt eTMF, the need for a standard is becoming indispensable and with vendors being on the front line to implement such a standard, their input is very important. Integration and alignment with the TMF reference model is also key, given the large number of industry players who have already implemented the model.


The TMF Reference Model interoperability sub-committee is in the process of organizing an online call with vendors in the coming weeks to discuss the different paths towards interoperability and to gauge their initial thoughts and intentions. This will help guide the work that the interoperability sub-committee will be undertaking to ensure that any interoperability standard is properly aligned with and leverages the TMF Reference Model.


If you are an eTMF solution vendor willing to participate in such a discussion or if there is a colleague within your organization who is more appropriate to participate, please get in touch with us to be part of this exciting work.

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