According to the ICH-GCP E6 (R2) addendum:
The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
How can Scandinavian CRO (SCRO) support your company to ensure adequate oversight?
Many small-to-midsize pharma and medical device companies do not have the resources or adequate knowledge to conduct full CRO oversight. With an experienced Oversight Project Manager from SCRO, the sponsor can meet the ICH-GCP oversight criteria and ensure tight communication with the CRO throughout their clinical study.
“We see an increased need for consultants in supporting sponsors in roles such as Oversight Project Manager,” says Ulrika Heldestad, manager for Clinical Operations at SCRO.
The Oversight Project Manager facilitates a successful collaboration with the CRO team by managing project team meetings and ensuring that the sponsor’s team is involved in the relevant aspects of the trial according to their role.
In addition to making sure that the CRO informs the sponsor of recent issues, the Oversight Project Manager also makes sure that the CRO actively prevents issues from reoccurring.
“It is sometimes a challenge for an Oversight Project Manager to make sure CROs feel like part of the team, while at the same time correcting them along the way to ensure they follow the right procedures,” says Ulrika.
Here are some examples of sponsor oversight activities:
• Review and approval of study documentation
• Review of site qualification and participation in the Site Initiation Visits
• Involvement in training of CRO staff and site staff
• Review of deviations and monitoring reports
• Perform co-monitoring visits
• Oversight checks of TMF
• Close monitoring of safety data
• Participate in regular team meetingsis means that biopharmaceutical
For more information about how we can support your company, please contact us.