Most CRO due diligence is performed on the CRO's own materials. The capabilities deck says the therapeutic experience is deep, the quality section says the inspection history is clean, and the org chart shows a team. All of it is true and almost none of it is verification.
Due diligence is the part where you check. Here is what to check, and how.
1. The named team, and whether they are actually available
Ask for the functional leads by name — project manager, lead CRA, data manager, medical monitor — and ask what else they are assigned to and through when. A lead who is fully committed to two other studies until the quarter you start is not available to you, whatever the proposal says.
Verify by asking for it in the contract. A CRO that will name people in a deck but not in a scope of work has answered your question.
2. Turnover, specifically in your therapeutic area
Company-wide turnover figures are close to meaningless. Ask for turnover in the therapeutic unit that would run your study, over the last eighteen months, at the CRA and project management levels.
Team continuity is one of the strongest predictors of delivery performance, and one of the least discussed in bid defense. A study that changes project manager twice will cost you more than one that does not, in ways that never appear as a line item.
3. Quality system and inspection history
Ask what inspections the organization has had in the last three years, from which authorities, and what the findings were. Ask how findings were remediated, and who owns CAPA closure.
Under E6(R3) this is no longer a box to tick. You retain accountability for the quality of delegated work, so you are effectively adopting the quality system you select.
4. Data ownership and system access
Confirm in writing: who owns the data, in what format it will be delivered, on what timeline, and what access you have to systems and audit trails during the study.
This is the item most often deferred to the contract stage and most often regretted. Access you did not negotiate is access you do not have, and oversight you cannot evidence is oversight that did not happen as far as an inspector is concerned.
5. Subcontractors and what they are doing
Ask which activities the CRO subcontracts — central lab, imaging, IRT, translation, ePRO — and how it oversees them. Your accountability extends through the chain. If the CRO cannot describe its own vendor oversight, it is not performing any on your behalf.
6. Reference studies of comparable complexity
Not the CRO's largest or most prestigious study. One that resembles yours in indication, phase, geography and complexity. If they cannot produce one, that is useful information rather than a disqualification — but it should change how you price the risk.
When you speak to the reference, ask the operational lead rather than the executive sponsor, and ask what went wrong. Every study has something. A reference with nothing to report was not close enough to the work.
7. Financial stability
For a small or mid-sized CRO this matters more than sponsors like to acknowledge. Ask about ownership, recent transactions, and whether the therapeutic unit you would use is growing or being consolidated. A CRO acquired mid-study is a governance event whether or not anyone tells you.
8. Enrollment performance, with evidence
Ask for actual versus planned enrollment on comparable studies, not modeled projections for yours. Ask how many sites activated on time. Ask what they did when enrollment was behind.
The answer to the last question tells you more than the numbers. A CRO with a rehearsed account of how it recovers an enrollment shortfall has done it before.
What the answers are worth
Score the responses, but score them on verifiability rather than quality. A CRO that provides turnover data, names its subcontractors and supplies a comparable reference has given you something you can check. A CRO that answers every question impressively but supplies nothing checkable has given you a sales performance.
It is also worth noticing which questions produce hesitation. The two that most reliably do are staff availability and inspection findings — and hesitation on either is a finding in itself, because both are known internally and neither is difficult to answer honestly.
How to use this list
Work through it before the bid defense, not after, so the meeting can be spent on the answers that need pressing rather than the questions that could have been sent in advance.
And weight the findings honestly. A CRO that is candid about a gap is usually a better partner than one whose answers are uniformly excellent. The second CRO has the same gaps; you just have not found them yet.
The full 40-criterion version, with a scoring workbook, is available as a free download: THE CRO SELECTION SCORECARD.
