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Buying CRO services does not mean the sponsor has transferred every project activity. Document inputs, specialist reviews, authorised decisions and internal system steps may remain with the sponsor. If these tasks are absent from capacity planning, external delivery can stall and the resulting delay may be attributed to the wrong party.
Decision framework
Translate sponsor-retained activities in the agreement into a visible work list. Identify necessary expertise, effort and triggering inputs for each task. Separate approval authority from capacity to prepare the assessment; a manager's signing authority does not demonstrate that a substantive review can happen that day.
Worked example
For example, a CRO completes an application package on time while sponsor review of product information waits behind another project. A plan tracking only external delivery cannot explain the delay. A revised capacity map shows the internal review and its prioritisation owner, allowing a realistic feedback date to be communicated to the CRO.
Implementation checks
- Add sponsor-provided inputs from the agreement explicitly to the plan as dependencies of the relevant deliverables.
- Assess specialists' available time alongside their commitments to other trials during the same period of work.
- Clarify what the provider should do and which activities should wait if a necessary input or approval is delayed.
Acceptance and boundaries
Accept the plan when the sponsor can demonstrate a practical arrangement for providing its own work on time. An internal task without resources should not be reported as supplier failure. Assess delegation and oversight boundaries with the applicable agreements; a schedule alone cannot redefine responsibilities.
Frequently asked questions
- Does each retained task need a separate employee?
- No. Make the necessary competence and capacity visible, then plan appropriate allocation between people.
- Must the CRO compensate for every sponsor delay?
- Assess agreements and feasible options rather than assuming an automatic obligation.