Attention on oversight - for quality and regulatory purposes

The success of clinical trials depends on strict adherence to ethical and scientific standards, as well as compliance with national laws, regulations, and global guidelines such as the ICH-GCP E6(R2). However, oversight of clinical trial activities outsourced to contracted vendors such as Clinical Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) can pose significant challenges for drug developers.

Contact a consultant

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.

Get in touch with us below 👇


Contact our director of Clinical Project Management

Send your inquiry to Maria Fernström

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