Health Canada PRCI/ EMA Policy 0070

Data Anonymization Requirements: A Moving Target

Data anonymization requirements change regularly, which makes it difficult for sponsors to comply while still preserving the utility of the data.

Tougher Regulations Equals Harder Submissions

Since the introduction of EMA’s Clinical Data Publication Policy (Policy 0070) and Health Canada’s Public Release of Clinical Information (PRCI), sponsors have faced ongoing challenges ensuring timely and accurate anonymization of personal data and redaction of commercially confidential information in clinical trial documents. As regulatory expectations change, navigating complex submission timelines and technical requirements has become increasingly demanding.

Protecting Privacy, Preserving Utility

Privacy Analytics delivers anonymization solutions that align with EMA Policy 0070 and HC PRCI requirements, ensuring the protection of personal data and commercially confidential information in clinical documents. Our proven methodologies and tools meet regulatory expectations while preserving data utility, enabling sponsors to confidently achieve compliance and support data transparency initiatives.

Redaction-as-a-Service

What?
Fast and cost-effective way to handle time-sensitive requests

Why

Speed
Cost-Efficiency
Simplicity

Best if...
You’ll need to publish a greater scope of documents under EU CTR, and you need to submit quickly and efficiently under EMA Policy 0700 and Health Canada PRCI.

Anonymization-as-a-Service

What?
Industry best practice approach for maximum transparency.

Why

Data Utility
Defensibility
Reputation

Best if...
You have clinical documents of public significance, and/or you want to honor the explicit preference of EMA and Health Canada for a utility-preserving approach.