In our recent review of regulatory guidelines, inspection reports from agencies such as the EMA and MHRA, and various published recommendations, one central finding emerged: sponsor oversight and vendor management consistently rank among the top reasons for inspection findings under E6(R2) and even earlier.
“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).”