Case Study: a major pharmaceutical sponsor delivers regulatory submissions on time with Privacy Analytics

Major Pharmaceutical Sponsor delivers all submissions on time with Privacy Analytics

The customer, a major pharmaceutical sponsor, faced the challenge of meeting tight deadlines for regulatory submissions to multiple agencies, including new requirements under the EU Clinical Trials Regulation and Health Canada's Public Release of Clinical Information. They needed to augment their team with privacy expertise and delivery capabilities. They engaged the vendor, Privacy Analytics, for its advisory and data anonymization services.

Privacy Analytics provided training in risk-based anonymization and regulatory processes, conducted public domain searches, and delivered the required anonymized and redacted submissions. The result was that the sponsor's team greatly enhanced their knowledge, all submissions were delivered on time, and they achieved regulatory acceptance.