Support the OASIS eTMF Standard Initiative

Are you involved with clinical trial regulatory document management as a sponsor, regulatory agency, consultant, research organization or technology expert, consultant, software vendor or services provider?

If so, then we urge you to participate in a the global effort to develop a new BioPharma industry interoperability standard for clinical trial content exchange.  Based on open source technologies,  the OASIS eTMF Standards initiative is a ‘standard based on standards’ that will help eliminate paper in clinical trials, automate manual paper handling processes, and ultimately enable faster delivery of new therapies at a lower cost to patients.

Initiated by the non-profit organization CareLex, the OASIS eTMF Standard initiative forming under OASIS, the global standards development organization with over 5,000 members from over 600 organizations worldwide.

Get involved today and make a difference in the future of clinical trial information automation and interoperability.  The initiative is open to all and the direction of the effort will be directed in an open, democratic process.

Details are at: or at OASIS.

For FAQs on the OASIS eTMF Standard and why you should care as an eTMF system user or vendor, view the SureClinical OASIS eTMF Standard FAQ at:

OASIS eTMF Standard Initiative News:

June 25 2014OASIS publishes eTMF Committee Specification Draft for 45-day Public Review

June 13 2014OASIS eTMF Standards Committee votes to adopt draft eTMF Standard Specification

November 2013 Forte Research, Oracle Health Sciences, SAFE-BioPharma and more join OASIS eTMF Standards Initiative 

October 2013eTMF Standards Initiative for Clinical Trial Data Exchange Gains Support 

September 2013eTMF Standards Initiative Forming under OASIS