Based on considerable experience of managing companies’ early submissions, Pooja Phogat, regulation and compliance expert at Kinapse, advises on the best approaches to balancing the risk of patient re-identification with the need for greater data utility.
end goal
The European Medicines Agency (EMA) Policy 0070 provides important guidelines and processes supporting the agency’s vision for a public database of clinical research findings.1 The goal is to increase industry transparency, yet without compromising trial participants’ privacy.