The sponsor’s responsibility doesn’t end at the contract
Under OECD GLP, the sponsor bears ultimate responsibility for the quality and integrity of the data generated in studies conducted at Contract Research Organisations. This responsibility is non-delegable — it persists regardless of the contractual language between sponsor and CRO. Yet many Indian sponsors treat CRO engagement as a procurement exercise: select the lowest bid, sign the contract, and wait for the final report.
This approach creates regulatory risk that materialises at the worst possible time — during a submission review or a regulatory inspection of the sponsor’s dossier.
Where oversight typically breaks down
The most common oversight failures we observe in Indian sponsor-CRO relationships fall into four categories. First, inadequate pre-qualification: sponsors select CROs based on price and turnaround time without conducting a meaningful facility audit or GLP compliance assessment. Second, insufficient Study Director engagement: sponsors do not maintain direct communication with the Study Director and instead route all interactions through business development contacts. Third, protocol amendment management: amendments are agreed verbally or via email without formal documentation that meets GLP requirements. Fourth, raw data access: sponsors do not exercise their right to review raw data during the study, relying entirely on the final report.
Building effective oversight without micromanagement
Effective sponsor oversight is not about micromanaging the CRO — it is about establishing a structured quality relationship. This includes: conducting a GLP-focused facility audit before study placement, defining communication protocols that ensure direct Study Director access, implementing a study monitoring plan with defined checkpoints, and exercising the right to raw data review at critical study milestones.
The commercial case for oversight
Proper CRO oversight is not just a regulatory requirement — it is a commercial imperative. Studies that fail due to GLP non-compliance at the CRO level must be repeated, at the sponsor’s cost, with the associated timeline delays. A structured oversight programme costs a fraction of a failed study and dramatically reduces the risk of regulatory rejection.
LaborWissen advises sponsors on designing and implementing CRO oversight programmes that are proportionate, practical, and defensible under regulatory scrutiny. We also provide independent CRO auditing services for sponsors who lack in-house QA capacity.