Independent CRO selection support for biotech companies — from requirements and shortlisting through RFP, bid defence, evaluation and award.
Selecting a CRO is one of the most important outsourcing decisions a clinical-stage biotech will make. Once a study is underway, changing provider can be expensive in cost, time and disruption.
For lean biotech teams in particular, the selection process can require significant time and specialist experience alongside the demands of preparing a clinical programme for execution.
A good CRO selection process starts before any CRO is contacted. Requirements need to be clear, assumptions consistent and the RFP structured so that proposals can be properly compared. An apparent price difference between two CROs can often be explained by differences in scope, assumptions or resourcing rather than underlying cost.
Henley provides independent support through the CRO selection process, from defining requirements and identifying potential providers through RFP, proposal evaluation, bid defence, final selection and negotiation.
We can support the complete process or step in at a particular stage where additional experience or independent review is required.
Defining what is being outsourced before going to market, so the RFP reflects the requirements of the study rather than a standard template.
Identifying and assessing potential CROs based on relevant capabilities, experience and fit with the clinical programme.
Developing the RFP and structuring bid defence meetings to understand how each CRO proposes to deliver the study.
Structured evaluation supported by operational and commercial review, providing a clear basis for CRO selection and negotiation.
Selecting a CRO is not simply a comparison of capabilities and headline budgets. Henley helps sponsors examine what sits behind each proposal, including:
The objective is to identify the CRO that represents the strongest overall fit for the programme — operationally, commercially and organisationally — rather than simply selecting the lowest initial proposal.
Henley is paid by the biotech sponsor and receives no commissions, referral fees or other payments from CROs.
Our role is to provide an independent perspective throughout the selection process, helping the sponsor challenge assumptions, compare options and make a well-informed decision before a significant outsourcing commitment is made.
Start by defining the requirements and what will remain within the sponsor. Build a short list of CROs with relevant capabilities, issue a clear RFP, compare proposals on a consistent basis and use bid defence to assess both the proposed approach and team. The final decision should consider delivery model, team, relevant experience, risk, scope and commercial terms — not simply headline price.
Three is often a practical number for a formal RFP. It provides meaningful comparison while keeping the process manageable for the sponsor and allowing each CRO to invest properly in its proposal. The right number will depend on the programme, the available CRO landscape and the objectives of the selection process.
There is no universally right answer. It depends on the therapeutic area, geography, study complexity, internal sponsor capabilities and the type of relationship required. Scale can be valuable, but so can access to experienced people, continuity and senior attention. The objective is to identify the CRO that best fits the programme rather than selecting by size alone.
Yes. Henley can step into an existing selection process to independently review CRO proposals, budgets, assumptions and resourcing, help structure bid defence or clarification discussions, and identify areas for further challenge or negotiation before final selection.
A structured CRO selection process will often take several weeks from requirements through to preferred-provider selection. The timetable depends on study complexity, the number of CROs involved, the RFP process and how quickly both the sponsor and bidders can respond. Where timelines are tight, the process can be designed accordingly without removing the key stages needed for an informed decision.
No. Henley is paid by the sponsor and receives no commissions or referral fees from CROs. Our advice is based on the requirements of the programme and our assessment of the available options.
If you are preparing to start a CRO selection process — or already have proposals that are difficult to compare — we would be happy to discuss it confidentially.
Arrange a confidential discussion→