Investor Advisory

Clinical delivery insight for investors funding biotech.

An independent view of whether a biotech's clinical programme can be delivered on time and on budget.

— Overview

Investing in a biotech means backing a clinical programme as much as the science behind it.

We support venture capital, private equity, growth equity, family offices and other investment organisations investing in clinical-stage biotech companies.

Most of the capital raised in a funding round is spent on clinical trials, and most of that is spent through CROs and other outsourced providers. Budgets, timelines, provider choice and contract terms can decide whether the money lasts long enough to reach the next milestone.

Henley gives investors an experienced, independent view of these questions before and after they invest.

We work alongside investment teams and their scientific, clinical, financial and legal advisers, focusing on the areas where we have direct experience.

— Experience

An insider's view of how clinical programmes are priced and delivered.

Henley brings 22 years of experience inside the CRO industry, including senior responsibility for proposals, pricing, contracts, strategic accounts and executive governance of clinical trials.

That experience includes direct involvement in more than £900m of contracted clinical trial value, including CRO services, vendor services and trial pass-through costs.

It gives investors a practical view of how trial budgets are built, where costs tend to grow and what good outsourcing and oversight look like inside a biotech.

— How we help

Three areas of investor support.

01

Biotech Investment Due Diligence

Testing the clinical delivery and outsourcing assumptions behind a potential investment.

  • ›Clinical development plan
  • ›Outsourcing strategy
  • ›CRO contracts and relationships
  • ›Trial budgets
  • ›Timelines and milestones
  • ›Internal team capability
02

Clinical Programme Assessment

An independent review of whether the programme budget and timeline are realistic for the funds being raised.

  • ›Budget benchmarking
  • ›CRO proposal review
  • ›Pass-through and vendor costs
  • ›Recruitment assumptions
  • ›Change order risk
  • ›Cash runway to milestone
03

Portfolio Biotech Support

Working with management after investment to protect budget, timelines and value.

  • ›CRO selection
  • ›RFP and proposal review
  • ›Budget and contract negotiation
  • ›CRO oversight and governance
  • ›Board reporting
  • ›Recovery of troubled studies
Investment team reviewing biotech diligence materials at a boardroom table
— How we work

Specialist clinical delivery input within the wider diligence process.

Our role can be tailored to the investment.

That may mean giving the investment team an independent view directly, reviewing specific CRO proposals or budgets, examining elements of an existing diligence report or working alongside a larger diligence provider.

We do not replace scientific, regulatory, financial or legal advisers. Our role is to bring clinical outsourcing and CRO experience to the questions where that view adds value.

— Investment Assessment

Looking behind the funding requirement.

A biotech's funding request rests on assumptions about trial cost, recruitment speed, provider performance and the time needed to reach a data readout.

Henley helps investors test those assumptions from a delivery perspective.

The focus is on practical questions:

  • →Is the trial budget realistic for the design and geography?
  • →Do the timelines reflect achievable patient recruitment?
  • →Has the right outsourcing model been chosen?
  • →Are the CRO contracts and payment terms sound?
  • →Where is the risk of change orders and cost overrun?
  • →Does the team have the capability to oversee its providers?
  • →Is the cash runway sufficient to reach the next milestone?
  • →What needs to change to protect the investment?
— FAQ

Frequently asked questions.

What does Henley assess before an investment in a biotech?

Our focus is how the clinical programme will be delivered and what it will really cost. This can include the clinical development plan, outsourcing strategy, CRO selection and contracts, trial budgets, timelines, the capability of the internal team and the assumptions behind the funding requirement. The exact scope depends on the investment and the work being undertaken by other advisers.

Can you work alongside scientific, clinical and regulatory advisers?

Yes. Henley focuses on the operational and commercial side of clinical delivery. We work alongside the scientific, medical, regulatory, financial and legal advisers already involved, so the investment team has a joined-up view.

Can you test whether the funding round is enough to reach the next milestone?

Yes. We review the trial budgets, CRO proposals and timelines behind the plan to judge whether the cash requested is realistic for reaching the next value inflection point, and where the main risks of overrun sit.

Can you support the biotech after investment?

Yes. Where appropriate, Henley can work directly with the management team on outsourcing, CRO selection, budgets, contracts and oversight, helping to protect the investment as the programme moves forward.

Do you provide scientific, regulatory, financial or legal due diligence?

No. Our role is focused on clinical trial outsourcing, CRO and delivery matters. We work alongside the appropriate specialist advisers where required.

Light-filled modern architectural interior with tall glass facade

Considering an investment in a biotech?

If you are assessing a biotech and would value an experienced view of its clinical programme, budget and outsourcing plans, we would be happy to discuss where Henley could help.

Arrange a confidential discussion→