1 week ago
#68031 Quote
Sponsors bear ultimate responsibility for clinical trial management, demanding robust oversight systems. This includes meticulous monitoring of outsourced tasks to guarantee participant safety and data integrity, as emphasized by regulatory bodies like the FDA and ICH E6 R2. Zenovel provides comprehensive sponsor oversight services, including contract management, vendor assessment, and prompt issue notification, ensuring adherence to GCP guidelines and mitigating potential risks throughout the trial lifecycle.

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