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Data Governance Under the EU AI Act: From Clinical Trial Analytics to Compliance
In clinical trials and healthcare, data comprise the foundation of every decision, from designing study protocols to analyzing patient outcomes. As artificial intelligence (AI) increasingly shapes clinical operations, data governance has become a critical factor in ensuring data quality, compliance, and ethical AI deployment. Data governance involves the management of data availability, usability, integrity, and

Jeanette Towles
Jan 17


Building a Compliant Quality Management System for AI in Healthcare
In healthcare and biopharma, ensuring patient safety, product quality, and regulatory compliance has always been paramount. A Quality Management System (QMS) serves as the backbone for these priorities, providing a structured framework for risk management, process standardization, and continuous improvement.

Jeanette Towles
Jan 16


Bridging Innovation and Compliance: Aligning Digital Transformation with the EU AI Act
Digital transformation in the biopharma industry isn't just about adopting the latest technologies—it's about fundamentally reimagining how clinical trials are designed, conducted, and analyzed. This shift involves integrating artificial intelligence (AI), cloud computing, and data analytics to streamline operations, accelerate drug development, and improve patient experiences.

Jeanette Towles
Jan 16
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