DDF 2017: Choosing a CRO, and the implications of new R2 regulations

As part of our video series for this year’s DDF 2017 event, life science leaders spoke to us about CRO needs.

Karen Gardner, senior director of clinical development at Seqirus, talks about the fact that “small biotechs spend a lot less money than the bigger biotechs, but they still get the delivery outcomes.” When choosing a CRO, quality does matter, she adds.

There was also discussion over the ICH GCP E6 R2 regulations, which, the EMA believes, will "provide increased clarity and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting.”

Gardner said in an interview with FierceBiotech: “I think the R2 implementation has been one of the biggest changes in clinical research, or will be, for a number of years. I think what's its actually doing is formalizing out a lot of the oversight activities that we've done in clinical and now making it mandatory.”

These things had typically been just good practice up until now. She said that the R2 addendum really does call out oversight, and some of the things that were once implicit are now mandated. “We have to prove to regulators the touch and the feel and how do we know the CRO did what they said they were doing.”

Check out our video below.