Articles & News

On 26 May 2026 the CNIL fined IQVIA Operations France EUR 5 million for failures in its two authorised health data warehouses, LRX and EMR. The decision exposes weaknesses in CRO data protection practice that have direct consequences for every pharmaceutical sponsor relying on a CRO to process patient, prescription or trial data. This article unpacks the four areas of failure, explains why pseudonymisation no longer offers the cover many sponsors assume, and sets out a practical oversight checklist for sponsor data controllers.

EU AI Act 2026 healthcare enforcement requires immediate compliance to avoid penalties.

US AI medical device compliance requires navigating FDA, HIPAA, IRBs, and consent waivers strategically.

Turkey's VERBIS registration and SCC requirements demand apostilles, tight deadlines, and experienced local guidance.

Are your global data protocols robust enough to withstand an audit by the Office of the Australian Information Commissioner (OAIC)? For international sponsors, Australia represents a premier destination for clinical research, but it also presents a sophisticated "privacy-by-design" regulatory environment. This analysis details the mandatory framework required to align cross-border operations with local statutory obligations and HREC expectations.

Turning clinical trial data into tomorrow’s breakthroughs isn’t just science—it’s law. We explore GDPR roadblocks, secondary use challenges, and the UK’s bold new approach.