WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research and a leading provider of software solutions designed to accelerate clinical trials safely, announced that it will encourage members of its Global Research Network (GRN) to accept the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for industry-sponsored, multi-center clinical trials.

Development of the ACTA was initiated in 2012 by the National Center for Advancing Translational Sciences (NCATS) through its Clinical and Translational Science Awards (CTSA) programme in collaboration with representatives from several pharmaceutical companies and took about two years to complete. NCATS is part of the National Institutes of Health. In 2014, the University Industry Demonstration Project (UIDP) joined the effort.

“All of WCG’s solutions help our clients to reduce the time, cost and risks associated with bringing new therapies to market,” said Donald A. Deieso, Ph.D., chairman and CEO of WCG. “The clinical trial process is plagued with administrative inefficiencies and unnecessary delays. We are proud to promote the hard work of the CTSAs and the UIDP, and to encourage our clients to adopt the ACTA.”


To date, approximately 225 institutions have agreed to the terms of the ACTA. WCG aims to increase that number significantly by promoting ACTA to the 1,200 institutions that belong to its GRN, which is a group comprised of research-intensive hospitals and universities, including one-third of all US academic medical centres, 27 of which are CTSA institutions and have agreed to accept the ACTA without revision.

“Data from a 2010 CTSA Contracts Processing Study showed that an average contract negotiation time of 55 days could be reduced to 22 days if a ‘master agreement’ was used,” said Petra Kaufmann, M.D., M.Sc., director of the NCATS Division of Clinical Innovation. “That information prompted us to challenge CTSA awardees to develop an efficient contract that, if adopted, could help reduce delays in trial start-up. We are pleased that WCG has recognized the potential of the ACTA, and delighted to have their support in disseminating its use.”

The ACTA was developed to facilitate negotiations between institutional research sites and industry sponsors by creating a straightforward and unambiguous document which clearly sets forth the regulatory and contractual obligations of both parties, and presents language which – while perhaps not ideal for either party – is acceptable to both. Adoption and use of the ACTA would expedite the contract process and reduce the time it takes to start up clinical trials.

“Our institutional and sponsor clients frequently cite the contract negotiation process as a source of frustration and delay, and as a barrier to clinical trial activation,” said Stuart Horowitz, Ph.D., M.B.A., WCG’s president of institutions and institutional services. “We applaud the CTSA institutions’ effort to address this significant problem.”

The Accelerated Clinical Trial Agreement (ACTA) is a standardized clinical trial agreement – a single agreement to be used by each participating institution and sponsor – to reduce contract negotiations for industry-sponsored, multi-site studies, specifically for phase 2b and phase 3 clinical trials. The ACTA was developed with support from the National Institutes of Health through the National Center for Advancing Translational Sciences’ Clinical and Translational Science Awards (CTSA) programme, grant #5U54TR000123. The CTSA Master Contracts Working Group is comprised of legal experts from about 25 CTSA institutions, in collaboration with industry representatives and the University Industry Demonstration Partnership.