Anonymizing any personal information contained in your trial documents prior to their publication is now required by multiple regulators.
You may have only weeks to provide a regulator with an assessment of how this data will be anonymized. This holds true for EMA Policy 0070 and Health Canada PRCI, for example.
How can your team rise to the challenge?
Evolving beyond redaction
A common approach to anonymization has been to simply redact patient information, using a rules-based method. This approach, however, destroys data utility and limits transparency.
Redaction is becoming increasingly unacceptable to regulators and the broader research community.
See how Privacy Analytics can help your organization achieve true trial transparency
The benefits of risk-based anonymization
Our health data experts, in conjunction with Privacy Analytics’ software, anonymize your documents using a risk-based approach.
Data transformation methods preserve patient privacy while maintaining the highest possible degree of data utility. Data is transformed only where necessary.
Our statistical approach to re-identification risk measurement provides a numeric result which can be easily demonstrated to fall below regulatory thresholds.
The most up-to-date, internationally recognized approach to anonymization helps you earn trust as regulatory bodies move away from accepting qualitative methods.
- 100% of a global sponsor’s dossiers were delivered on time and accepted by regulators.
- Over 90 clinical study reports of varying formats and complexities –anonymized.
Still not convinced?
Learn more about the complex regulatory challenges that clinical trial sponsors face and how our methodology and expertise take this burden from your team’s shoulders.
Let’s help you meet regulatory and privacy obligations while
fulfilling expectations for sharing clinical trial documents.
We look forward to helping you with your regulatory obligations and data sharing needs. One of our experts will be in touch shortly.