TMF Reference Model and the OASIS eTMF Model

["Mowaswes, Sam" <smowaswes@dsi.com>]

All,

 

The TMF Reference model represents the collective input of over 300 subject matter experts at large and small Pharma, CROs, and vendors. The model was developed with a vision in mind to accomplish the following:

 

-      improve collaboration related to drugs co-development

-      enhance interaction with health authorities during regulatory inspections or approval

-      simplify data exchange operations between sponsors and service providers

-      introduce efficiencies in Trial Master Files management

-      Establish a scalable standard applicable to paper and electronic TMFs

 

Any deviation or misalignment with the TMF Reference Model V2.0, should be rejected. Since it will undermine the work of many professionals affiliated with over 200 organization and will for certain lead to minimal adoption. It is my hope, the OASIS team would reconsider the interoperability approach and adopt the TMF Reference as the foundation. I believe the initial work is encouraging, but we need OASIS to commit to maintaining alignment with the TMF Reference Model throughout the entire development process.

 

Regards,

 

 

Sam Mowaswes, MS

Director, Records and Information Management

Regulatory Affairs

 

Daiichi Sankyo, Inc.

399 Thornall Street

Edison, NJ 08837• USA

Phone: + 1 732-590-5123

Mobile  +1 908 337-8791

Fax +1 732 906-5690

smowaswes@dsi.com

www.dsi.com  

 

Passion for Innovation.

Compassion for Patients.^TM