Regulatory obligations to increase public access to clinical study data grow increasingly stringent and this poses challenges to the healthcare industry.
Health agencies have mandated the release of anonymised clinical information under policies such as EMA Policy 0070, EMA Policy 043, Health Canada PRCI and Japan’s PMDA, while USFDA is actively working towards a harmonized system for disclosing study reports related to drug approval decisions.
To help customers navigate this, our de-identification service ‘redact360’ combines our deep clinical transparency expertise with innovative technology. redact360, supports a risk-based anonymisation approach (applying redaction and appropriate transformation techniques) to optimize clinical utility fostering secondary research while safeguarding data privacy. This service enables clients to responsibly disclose clinical information under open access arrangements like public registries (ClinicalTrials.Gov), portals (EMA, Health Canada PRCI) and more controlled and restricted platforms like Clinical Study Data Request (CSDR).