Posts Tagged ‘clinical development plan’
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…
Read MoreBuilding 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. As artificial intelligence (AI) becomes more embedded in clinical operations and drug development, traditional QMS…
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