“The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf”
[ICH GCP E6 (R2) addendum]
CyntegrityPro is a sponsor oversight service, which pharma organizations have to fulfill following the new GCP compliance
Why must a pharmaceutical organization (PhO) control its studies?
One can delegate a task, but one cannot delegate responsibility. Cyntegrity monitors the fulfillment of milestones and performance metrics for PhO in the “sponsor oversight” function. The monitoring is done by the top expert, who fulfill this activity remotely.
Who is our customer?
Smaller and mid-sized PhO, who wants to concentrate on process of drug investigation and need help in CRO oversight. Besides, it is more cost-effective for them as to fulfill this function on their own.