The new ICH E6(R3) guidelines are set to reshape how sponsors manage essential records (documents and data) and their relationships with contract research organisations (CROs), reports Pinar Bérénice Bénet (pictured), Senior Director of Strategy, Clinical Operations, at Veeva.
These changes emphasise a proactive, data-driven approach to running clinical trials and sponsor oversight, requiring biopharmaceutical companies to rethink their systems, processes, workflows and partnerships.
The global pharmaceutical industry has been navigating increasing trial complexity, globalisation and costs.
Against this backdrop, the International Council for Harmonisation’s Good Clinical Practice (GCP) guidelines, known as ICH GCP, are evolving to reflect the digital/outsourced nature of modern clinical trials.
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