EU-CTR Challenges Drug Developers Faced in the First 6 Months
Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive 2001/20/EC), drug developers must now anonymize or redact clinical trial documents at the same time they are preparing them for regulatory submission (read more about the redaction process in this blog). This makes complying with transparency and disclosure requirements necessary … Continued
https://www.certara.com/blog/eu-ctr-challenges-drug-developers-face/