AG Mednet Helps Sponsors Comply With New FDA Guidance for Clinical Trials

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BOSTON--(BUSINESS WIRE)--Improved quality-control measures in clinical trials are gaining traction. AG Mednet, driven by its mission of quality at the source for image-intensive trials, helps sponsors and core labs comply with the FDA’s newly stated guidance. The FDA has issued, “Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring,” for sponsors running clinical trials. According to this guidance, “FDA encourages sponsors to develop monitoring plans that manage important risks to human subjects and data quality and address the challenges of oversight in part by taking advantage of the innovations in modern clinical trials.”

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