The challenge
A large, global pharmaceutical sponsor faced tight deadlines to deliver a portfolio comprised of over 450 clinical trial documents and 18 submissions for European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI).
Many of the submissions were large and complex. For example, a single submission could include up to several dozens of documents with well over 100,000 pages. Some had very short deadlines, including one with only five weeks available to prepare the submission.
The solution
The drug sponsor leveraged Privacy Analytics’ services to anonymize all the dossiers using a proven statistical, risk-based methodology espoused by the EMA and Health Canada.
The results
Leveraging our service, 100% of the sponsor’s dossiers were delivered on time and accepted by regulators. This included anonymizing over 90 clinical study reports of varying formats and complexities and meeting stringent deadlines.
Learn about Privacy Analytics’ clinical document anonymization services.
