Privacy: The Next Competitive Edge in Clinical Operations
In today’s research environment, where technology, data, and patient engagement intersect, Clinical Operations has never carried greater responsibility. Yet despite the growing complexity of modern trials, privacy remains one of the most overlooked dimensions of operational excellence. I have seen it countless times. The moment a presentation turns to data protection, the room starts to […]
The Essential Role of the Data Protection Officer (DPO) in Clinical Trials
DPO clinical trials
ICO Fine Signals Urgency for GDPR in Clinical Trials
In March 2025, the UK Information Commissioner’s Office (ICO) announced a £3.07 million fine against Advanced Computer Software Group Ltd, a supplier to the NHS, following a ransomware attack in 2022 that compromised the personal data of over 79,000 individuals. This decision has made waves across the healthcare sector – not just because of the […]
Running Trials in France? Know MR-001 & GDPR
When planning clinical trials in France, Sponsors must go beyond meeting the requirements of the General Data Protection Regulation (GDPR). Local rules add another layer of complexity—and overlooking them can stop a trial before it even begins. Even if a study is fully GDPR-compliant, Sponsors won’t receive the go-ahead from the French authorities unless they […]
Clinical Trial Agreements: Privacy Compliance Guide
Clinical trial agreements (CTAs) are the foundation of collaborations between sponsors and clinical trial sites. According to ICH-GCP guidelines, these agreements must clearly define the roles, activities, and responsibilities of each party and be properly documented. Additionally, the General Data Protection Regulation (GDPR) mandates that joint controllers determine their respective responsibilities through a contractual agreement. […]
Pseudonymized Data in Clinical Trials: Why EDPB’s Perspective Should Prevail Over ICO’s Guidance
The European Data Protection Board (EDPB) Guidelines on Pseudonymization state: “Pseudonymised data, which could be attributed to a natural person by the use of additional information, is to be considered information on an identifiable natural person, and is therefore personal. This statement also holds true if pseudonymised data and additional information are not in the […]
Data Subject Rights in Clinical Trials
The General Data Protection Regulation (GDPR) grants individuals a range of rights over their personal data, and sponsors of clinical trials must carefully navigate these obligations to ensure compliance. Unlike other industries, clinical trials involve unique complexities due to the need to protect scientific integrity, ensure participant safety, and comply with regulatory requirements. This guide […]
When GDPR Gets Personal: Dutch DPA Holds Clearview AI Directors Accountable
In September 2024, the Dutch Data Protection Authority (DPA) made headlines by announcing an unprecedented move to hold the directors of Clearview AI personally liable for GDPR violations. This case, involving a fine of €30.5 million against the company, marked a pioneering moment in the enforcement of the General Data Protection Regulation (GDPR), signaling a […]
NOYB Qualified to Bring Collective Actions: Boost for GDPR Enforcement
In a significant development for data protection and privacy advocacy, noyb (None of Your Business), the European Center for Digital Rights founded by Max Schrems, has received official qualification to bring collective redress actions under Article 80(2) of the General Data Protection Regulation (GDPR). This marks a major step forward in empowering individuals to collectively […]
How to Conduct a DPIA: Best Practices for Small Biopharma
Data Protection Impact Assessments (DPIAs) are essential tools for identifying and managing privacy risks, particularly when handling sensitive health data in clinical trials and research. For small biopharma companies, conducting a DPIA is critical for ensuring compliance with the General Data Protection Regulation (GDPR) while building trust with trial participants. By adhering to best practices, […]
