Outsourcing can bring valuable expertise, flexibility and speed. It can also create blind spots if sponsor oversight is not designed properly from the outset. In my experience, the most common outsourcing gaps are rarely dramatic on day one. They tend to sit quietly in the background until they show up in an audit, inspection or study issue review.
Here are five of the most common ones.
1. Unclear transfer of responsibilities
Many outsourcing models still rely on vague assumptions about who owns what. Activities may be described at a high level in a contract, but the operational boundaries are not clear enough to support proper execution or oversight. ICH E6(R3) is explicit that transferred activities should be documented in an agreement, and that activities not specifically transferred remain with the sponsor.
2. Overreliance on certifications instead of real qualification
ISO certification, reputation or prior experience can be useful indicators, but they are not substitutes for sponsor due diligence. ICH E6(R3) requires the sponsor to assess the suitability of the service provider and to have access to relevant information, including SOPs and performance metrics, for selection and oversight.
3. Poor visibility of subcontracting
A sponsor may believe it has qualified one provider, only to discover later that critical work is being performed elsewhere. ICH E6(R3) now states clearly that sponsor oversight should extend to important trial-related activities that are further subcontracted by the service provider.
4. Weak evidence of ongoing oversight
Review calls may happen regularly, but that does not automatically equal oversight. If there is no documented review of metrics, no evidence of issue tracking, no follow-up of trends, and no visible escalation route, the sponsor may struggle to demonstrate control. ICH E6(R3) expects oversight measures to be fit for purpose and requires timely escalation and follow-up of issues. MHRA has also published examples where lack of demonstrable oversight resulted in major or critical findings.
5. Treating systems and records as the Service Providers problem
Sponsors sometimes assume that system validation, data handling, TMF control or record accessibility sit entirely with the provider. That is risky. In UK guidance, MHRA states that sponsor functions include development and maintenance of trial-specific computerised systems and oversight of laboratories. MHRA inspection guidance also makes clear that the complete TMF must be available for inspection, including electronic records and emails, even where activities have been subcontracted. ICH E6(R3) further requires computerised systems used in trials to be validated as fit for purpose. (GOV.UK)
The message is simple: outsourcing is not the problem. Invisible outsourcing is. Sponsors that define responsibilities clearly, qualify providers properly, maintain visibility of subcontracting, document oversight and stay close to critical systems are in a far stronger position than those that rely on trust alone.
MSAQS supports sponsors in identifying and closing outsourcing gaps before they become inspection findings, study risks or governance failures.
