Pharma and Biotech Archives

Compliant AI in Clinical Trials: Governing Agent Access to TMF Data

by Danielle Barbour March 25, 2026March 25, 2026 | Regulatory Compliance

Clinical trial operations are one of the most document-intensive regulated environments in any industry. Protocol amendments, investigator brochures, informed consent forms, site monitoring reports, serious adverse event records, regulatory submissions...

How European Pharmaceutical Companies Can Share Clinical Trial Data Across Borders While Maintaining European Sovereignty

by Marc ten Eikelder February 11, 2026 | Regulatory Compliance

European pharmaceutical companies operate in one of the most data-intensive and heavily regulated industries on the continent. A single multinational clinical trial can generate patient health records, genomic data, adverse...

How to Protect Clinical Trial Data in International Research

by John Lynch October 17, 2025December 23, 2025 | GDPR Compliance

International clinical trials generate vast amounts of sensitive data requiring protection under multiple regulatory frameworks simultaneously. Patient health information, trial protocols, and research results must satisfy FDA regulations, EMA requirements,...

External File Sharing Governance for Transforming Care

by Bob Ertl October 31, 2024September 24, 2025 | HIPAA Compliance

External file sharing governance is challenge for many healthcare organizations (HCOs), but it’s a challenge they need to address to deliver the best possible care while ensuring compliance with data...