Preparing a clinical document for public disclosure comes down to a series of judgment calls. Which indirect identifiers still pose a re-identification risk once direct identifiers have been addressed, and what justification for a commercially confidential redaction will withstand regulatory scrutiny. Worldwide Flex transparency and disclosure services make those decisions alongside your team and carry them through to a publication-ready package. This includes anonymization and redaction, CTIS disclosure support, and compliance alignment across GDPR and EMA transparency requirements. Because the work is delivered by the same medical writing organization that supports your regulatory and safety documents, redaction decisions stay aligned with document content and fewer handoffs are needed, all managed by a dedicated Transparency and Disclosure Lead under a defined SOP.
Read our fact sheet to learn more about our transparency and disclosure services, including:
- A structured workflow from onboarding through final redacted document, with a Marked for Redaction version provided for sponsor review and quality-checked for compliance and consistency
- Protection of both personal data (direct and indirect identifiers) and commercially confidential information, with GDPR-aligned privacy protection and EMA-aligned redaction labeling
- Global, scalable support across North America, the U.K., Europe, and India, with expedited handling for urgent requests and coverage for non-English documents and multinational programs
