According to ICH-GCP:
The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including those subcontracted to another party by the sponsor’s contracted CRO(s).
Many pharma and medical device companies do not have the resources or adequate employee competence to conduct full oversight of their contract research organizations (CROs).
With an experienced Oversight Project Manager from SCRO, the Sponsor can meet the GCP oversight criteria and ensure tight communication with the CRO throughout the study.
Contact us to find out how we can support your company to ensure adequate ICH-GCP oversight.