Sponsor Oversight
Elevating your trials by Seamless Execution, Compliance, and Data Integrity with our Sponsor Oversight mechanism
Elevating your trials by Seamless Execution, Compliance, and Data Integrity with our Sponsor Oversight mechanism
The sponsor holds sole accountability for management and monitoring of clinical trials. Therefore, there should be systems in place to ensure that contracted or outsourced tasks are being closely monitored guaranteeing patient wellbeing and data integrity.
USFDA has recommended the “Guidance for Industry Oversight of Clinical Investigations – — A Risk-Based Approach to Monitoring”emphasizing the importance of effective monitoring to protect human subjects and ensure high-quality studies. Sponsors of clinical investigations involving human drugs are required to provide oversight to ensure the rights, welfare, and safety of subjects and the quality of clinical trial data submitted to the FDA.
As per ICH E6 R2, the sponsor may establish an independent data monitoring committee (IDMC) to assess the progress of a clinical trial, including safety data and critical efficacy endpoints. The IDMC should have written operating procedures and maintain records of meetings. The sponsor should ensure oversight of trial-related duties and functions carried out on its behalf, including those subcontracted to another party by the sponsor’s contracted CRO(s).
Adherence to GCP is crucial and should be prioritized over internal policies and procedures. The contract should address subcontracting and outline the sponsor’s oversight of additional subcontracting. However, key legislative requirements, such as reporting urgent safety measures and serious breaches, are often missing from contracts, potentially leading to non-compliance due to unclear roles and responsibilities.
Zenovel maintains the highest standards for safeguarding patients and ensuring data authenticity through comprehensive supervision procedures, guaranteeing efficient management and monitoring of clinical studies.
Risk-Based Monitoring (RBM) is a more efficient alternative to traditional clinical trials, focusing on high-risk areas through data-driven insights. It ensures patient safety, data integrity, and regulatory compliance while reducing costs and timelines. However, the success of RBM depends on the competency of monitors, who identify risks, analyze data, and
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