A major pharmaceutical sponsor had immediate delivery needs for multiple regulators and very short timelines to work within. In response to disclosure requirements under European Union Clinical Trials Regulation (EU CTR) – and being new to international regulations such as Health Canada Public Release of Clinical Information (PRCI) – they wanted to augment their team with privacy and regulatory expertise, and delivery capabilities.
The sponsor engaged Privacy Analytics to train their team in risk-based anonymization, regulatory processes, and identification and justification of commercially confidential information (CCI)/confidential business information (CBI). We also conducted public domain searches for CBI under Health Canada PRCI and delivered anonymized/redacted submissions for this requirement as well as EU CTR.
Leveraging Privacy Analytics’ advisory and delivery services, the sponsor’s team has greatly enhanced their knowledge, especially their understanding of CCI/CBI and anonymization. All submissions were delivered on time and garnered regulatory acceptance.