Clinical development feasibility
The operational assumptions underpinning the clinical development plan, including trial timelines, recruitment expectations, resource requirements and key dependencies.
Investor Advisory
Biotech investment due diligence.
Independent assessment of clinical trial outsourcing, budgets and delivery risks to support informed investment decisions.
— Overview
Understanding the risks behind clinical development.
For clinical-stage biotech companies, investment value is closely linked to the successful delivery of clinical milestones, within the available funding and planned timelines.
Henley Biotech Partners provides independent commercial and operational due diligence, helping investors assess whether a company's clinical development plans are supported by realistic budgets, appropriate outsourcing arrangements and effective oversight.
Drawing on extensive experience working within the CRO industry, we provide an informed perspective on the costs, commercial commitments and execution risks associated with outsourced clinical trials.
Our work complements scientific and regulatory due diligence, providing investors with greater visibility of the practical challenges involved in delivering the clinical programme.
— How we help
What we assess
Outsourcing strategy
Whether the proposed outsourcing approach, including full-service CRO, functional service provision (FSP) or hybrid models, is appropriate for the programme, available resources and internal capabilities.
CRO selection and commercial arrangements
The suitability of selected CROs and service providers, the robustness of the selection process, and the commercial terms, contractual commitments and responsibilities established.
Clinical trial budgets and funding requirements
The completeness and realism of CRO budgets, including assumptions, pass-through costs, potential change orders and the financial exposure associated with clinical trial delivery.
Sponsor capabilities and oversight
Whether the biotech has the internal resources, experience and governance arrangements needed to manage outsourced providers, oversee performance and address emerging delivery issues.
Key risks and investment considerations
Identification of material outsourcing, commercial and operational risks, together with practical recommendations and areas requiring further clarification before investment.
— Our output
Clear findings to inform investment decisions.
We provide investors with a concise, independent assessment of the clinical programme's commercial and operational delivery risks.
Our findings can include:
- →Key observations on clinical outsourcing arrangements and execution readiness.
- →Assessment of CRO budgets, commercial commitments and potential cost exposure.
- →Identification of material risks to trial delivery, timelines and funding requirements.
- →Priority questions for management and areas requiring further investigation.
- →Practical recommendations to strengthen delivery arrangements and oversight.
Findings are presented in a format suitable for investment committee consideration, supported by direct discussion with the investment team.
Where appropriate, we can also participate in management discussions to explore specific concerns.
— FAQ
Frequently asked questions.
When should Henley be involved in an investment?
Ideally during the due diligence process, once the company has provided its clinical development plan, budgets and relevant CRO proposals or contracts. Early involvement allows sufficient time to identify issues and address questions with management before investment decisions are finalised.
How does your work differ from scientific or regulatory due diligence?
Scientific and regulatory due diligence typically considers the underlying science, clinical evidence, development strategy and regulatory pathway. Henley focuses on the commercial and operational aspects of clinical trial delivery, including outsourcing arrangements, CRO budgets, contractual commitments and sponsor oversight capabilities.
What information is required?
Typically, the clinical development plan, trial timelines, CRO proposals and budgets, relevant contracts, recruitment assumptions and details of the internal team. Reviews can be undertaken using an investment data room or through direct engagement with management.
How quickly can a review be completed?
The scope and timetable are agreed at the outset. Focused assessments can be structured around transaction deadlines, with the depth of review determined by the available information and specific investor requirements.
Is Henley independent of the CROs being assessed?
Yes. Henley provides independent, investor-side advice and receives no commissions or referral fees from CROs or other service providers.
Assessing a biotech investment?
Understand the outsourcing, commercial and delivery risks behind the clinical development plan before committing capital.
Arrange a confidential discussion→