The proposed changes to European clinical trial regulations accepted by the European Commission (EC) in July will put Europe on an equal playing field, according to Clinipace’s Andrea Schiefer.
Submitting a REMS (Risk Evaluation and Mitigation Strategies) proposal for risky drug developments could earn companies brownie points, according to Quintiles’ Ed Tabor.
Negotiating funding for drugs with local health authorities prior to commercialisation is the key to success for biopharmas working in the changing European market, says Quintiles.
‘CROs: look at the entire portfolio, not just the individual project, when planning clinical studies,’ says DIA’s adaptive design scientific working group.
