Clinical trial budget realism
Whether proposed trial budgets adequately reflect the study scope, geographic footprint, patient population, duration and expected operational requirements.
Investor Advisory
Clinical programme assessment.
Is the funding available sufficient to reach the next clinical milestone?
— Overview
Understanding the true cost of clinical development.
Clinical trial budgets and timelines are major considerations in biotech investment decisions. Optimistic recruitment assumptions, incomplete CRO proposals and underestimated third-party costs can result in significant additional expenditure and delays before a company reaches its next clinical milestone.
Henley Biotech Partners provides investors with an independent assessment of the commercial and operational assumptions underpinning a clinical development programme.
Drawing on extensive CRO-side experience, we assess whether proposed budgets, outsourcing arrangements and delivery timelines are realistic, and identify where additional costs or delays could affect the funding required.
— How we help
What we assess
CRO proposals and commercial assumptions
The completeness of CRO proposals and contracts, including scope, resourcing, pricing structures, assumptions, exclusions and responsibilities.
Pass-through and third-party costs
The treatment of investigator fees, central laboratories, imaging, clinical supplies and other third-party costs, including potential areas of underestimation or omission.
Recruitment and timeline assumptions
Whether planned site activation, patient recruitment and study timelines are operationally credible, and the potential cost implications of delays.
Change order and cost escalation risks
Identification of scope gaps, contractual assumptions and delivery dependencies that could result in additional charges or budget increases during execution.
Funding adequacy and contingency
Whether the anticipated clinical development expenditure, including potential cost increases and delays, is consistent with the funding allocated to reach the next milestone.
— Our approach
Practical, evidence-based findings.
We review the company's clinical development plans, CRO proposals, budgets and relevant contractual arrangements, drawing on direct experience of how clinical trials are priced, contracted and delivered.
Where appropriate, we engage with management to clarify assumptions and understand the rationale behind key estimates.
Our findings provide investors with a clear view of:
- →The credibility and completeness of the proposed clinical trial budget.
- →Material cost exposures, exclusions and potential change orders.
- →Timeline and recruitment assumptions that could affect expenditure.
- →Areas where additional funding or contingency may be required.
- →Priority questions and recommended actions before committing capital.
— FAQ
Frequently asked questions.
Can you benchmark a clinical trial budget?
Yes. Drawing on extensive experience of CRO pricing and proposals, we assess whether budgets are commercially reasonable for the proposed study scope, geography, patient population and delivery model. We also identify potential omissions, assumptions and areas of cost exposure.
Can you review CRO proposals before a contract is signed?
Yes. We review individual or competing CRO proposals to assess scope, pricing, resourcing, assumptions, exclusions and commercial terms, highlighting potential areas of risk before contractual commitments are made.
Do you assess clinical trials that are already underway?
Yes. For ongoing studies, we can review expenditure, recruitment progress, contractual commitments and change orders against the original plan to identify emerging cost and timeline risks.
Can you assess whether the funding raised will be sufficient?
We assess the clinical development costs and potential additional expenditure associated with the programme, helping investors understand whether the funding allocated to clinical trial delivery is realistic. Our work complements the company's wider financial forecasts and cash runway modelling.
Need an independent assessment of a clinical trial budget?
Understand the commercial assumptions, potential cost exposure and funding requirements behind a biotech's clinical development programme.
Arrange a confidential discussion→