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Defining outputs rather than activities in a CRO request for proposal

When a CRO request for proposal contains only activity names, bids may appear to cover identical work.

Representative research photograph: Defining outputs rather than activities in a CRO request for proposal
Photo: Polish presidency of the Council of the EU 2025 · License: Public domain · Cropped and resized.
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When a CRO request for proposal contains only activity names, bids may appear to cover identical work. Document review, dossier preparation and authorised acceptance are different outputs, however. Comparable proposals begin with the sponsor explaining what result is needed and why it matters.

Decision framework

Show study scope, known document maturity and sponsor-provided inputs in the request. Define each deliverable's format, reviewer, expected feedback and acceptance condition. Where country or site numbers remain unknown, ask bidders to state explicit assumptions rather than quietly selecting their own estimates.

Worked example

For example, two proposals both offer regulatory support. One includes dossier assembly only; the other also assesses local requirements. The sponsor clarifies this difference before negotiating price. Otherwise the apparently cheaper bid may later require additional work. The difference does not itself demonstrate poor supplier performance.

Implementation checks

  • Describe the tangible output of every work package and identify inputs expected from other teams separately.
  • Ask bidders to state exclusions and the circumstances that would change their estimate in clear terms.
  • Base technical evaluation on the practical proposed workflow as well as the supplier's presentation of its capabilities.

Acceptance and boundaries

Use the request when independent bidders understand its delivery boundaries consistently. Legal and purchasing teams should evaluate contract-specific commercial terms. A well-defined proposal request does not remove the need for appropriate oversight of the chosen provider throughout the trial.

Frequently asked questions

Must every detail be known at the outset?
No. Unknowns can be managed through visible assumptions and later decision points.
Is a standard service list sufficient?
It is a starting point; study inputs, delivery boundaries and acceptance conditions still need explanation.

Sources

  1. EMA — ICH E6 good clinical practice
  2. WHO — Guidance for best practices for clinical trials