Have you assessed the impact of EMA Policy 0070 on your organization yet?
Due to evolving regulations such as EMA Policy 0070 and the HHS NIH Final Rule, there is a growing need to disclose anonymized clinical documents publicly. Our continual assessment of these regulations and involvement in industry working groups will help you keep up with the latest information and future trends. MMS provides an array of services to prepare redacted documents for mandatory public posting, voluntary data sharing commitments or for responding to external requests under FOIA.
Our key redaction service features include:
- Redaction of documents ranging from clinical study reports, synopses, protocols, statistical analysis plans and CTD summaries
- 95% automated identification of CCI and PPD, followed by a rigorous scientific review and QC, producing high quality redacted documents
- Anonymization report development and transparency ready clinical document templates to ensure study documentation is redaction friendly