As a sponsor, it is essential to ensure that all trial-related duties and functions are adequately supervised, including those subcontracted to third-party vendors. Our team of experts ensures that your clinical trial complies with all relevant regulations and guidelines, reducing the risk of critical findings and avoiding unnecessary delays.
Our Sponsor Oversight Services
- Advice regarding what risk-based sponsor oversight activities are required and documentation thereof.
- Perform vendor and CRO assessment before contracting and continuously during the trial.
- Acting as the link between the sponsor and vendors or CROs contracted in the study.
- Managing oversight via regular meetings, including performance review and issue review with vendors and CROs and communicating relevant trial aspects to the sponsor.
- Write and implement sponsor-level management plans (risk management and sponsor oversight plans) as well as review CRO study management plans (monitoring and safety management plans)
- We quality-review study documents such as status reports, trial master files, and monitoring reports.
- Participate in audits and inspections and support with issue resolution if needed.
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