Generative AI in Clinical Trials At Just in Time GCP, we know the pressure trial sponsors face to stay inspection-ready while managing the quality and completeness of the Trial Master File (TMF). Generative AI is opening new opportunities to address these challenges—helping sponsors balance speed, cost, and compliance while strengthening TMF integrity. Understanding the Challenges […]
Clinical Process Assessment: Aligning Operations with Trial Scope and GCP Compliance A recent roundtable on clinical process assessment revealed a growing gap between current clinical operations and the capabilities needed to run today’s complex studies. Conducting a comprehensive review of processes, systems, and infrastructure ensures alignment with regulatory requirements, compliance expectations, and available resources. A […]