Independent advice built on more than two decades of experience inside the CRO industry.
Outsourcing is one of the largest commitments a clinical-stage biotech will make. For emerging and growing biotech companies, these decisions often need to be made quickly and with limited internal outsourcing resource, while the consequences for cost, timelines and delivery can last for years.
Henley provides independent clinical trial outsourcing support throughout the CRO relationship: deciding what to outsource, identifying the right CROs, running the RFP, comparing proposals, reviewing budgets and commercial terms, negotiating before award, establishing effective oversight and governance, and addressing performance issues if they arise.
Support can cover the complete outsourcing process or provide additional experience and capacity at a particular stage.
Henley brings more than two decades of CRO industry experience across business development, strategic accounts, proposals, pricing, contracts and executive governance of clinical trials.
That experience provides a practical understanding of how CRO proposals are developed, how budgets and assumptions are constructed, where commercial flexibility may exist, how CRO relationships are managed and what should be tested before a significant outsourcing commitment is made.
We use that experience on the sponsor's side of the table — helping biotech teams understand what sits behind CRO proposals and commercial models, establish effective relationships after award, and address issues when performance does not meet expectations.
Henley is independent and receives no fees, commissions or referral payments from CROs. Our role is to represent the interests of the biotech sponsor throughout the outsourcing process and CRO relationship.
Defining what to outsource and which model is right for the programme — full-service, FSP or a combination of the two — before going to market.
A structured and independent process for identifying, assessing and selecting the CRO that best fits the programme.
Independent review and comparison of CRO proposals, including scope, assumptions, pricing, resourcing, proposed team and potential change-order exposure.
Independent commercial review of CRO budgets, assumptions and contract terms before a significant outsourcing commitment is made.
Helping sponsors establish effective CRO governance and performance oversight, address significant issues and intervene when a relationship is not performing as expected.
Henley does not need to be involved from the beginning of an outsourcing process.
We can support a complete CRO outsourcing programme or provide an independent senior perspective at a particular decision point — whether a sponsor is preparing to go to market, selecting between CROs, reviewing proposals already received, approaching contract signature or dealing with concerns about an existing CRO relationship.
This allows support to be focused on the decisions where additional experience can add the greatest value.
Henley can support biotech companies approaching their first major CRO selection, preparing for a clinical trial RFP, comparing complex CRO proposals, negotiating budgets and contracts, establishing CRO oversight or addressing performance concerns within an existing relationship.
This can be particularly valuable for lean biotech teams that need experienced outsourcing support at a critical stage without adding permanent senior resource.
Where an engagement requires additional clinical or operational expertise, Henley can bring experienced clinical consultants into the team, allowing support to be tailored to the programme and the issues involved.
We help biotech companies make better CRO and clinical trial outsourcing decisions throughout the CRO relationship.
This can include deciding what to outsource, identifying potential CROs, running an RFP, comparing proposals and budgets, supporting commercial negotiations, establishing effective CRO oversight and helping management address significant CRO performance issues.
Yes. Henley can provide experienced outsourcing support alongside the existing management and clinical team.
This can cover the complete CRO outsourcing process or provide additional expertise and capacity at a particular stage.
Our perspective comes from more than two decades working inside the CRO industry, including direct experience of business development, proposals, pricing, contracts, strategic accounts and executive governance.
We use that experience on the sponsor's side of the table to help clients understand how CRO proposals and commercial models are constructed, which areas warrant further scrutiny or negotiation and how the relationship can be effectively governed after award.
Yes. We can support the complete outsourcing process or provide advice at a particular stage, such as outsourcing strategy, CRO selection, RFP preparation, proposal review, budget review, negotiation or CRO oversight.
Yes. Henley can help establish or strengthen CRO governance, independently review performance, support executive escalation and help management determine the appropriate response where an existing CRO relationship is not performing as expected.
Where more significant intervention is required, this can include recovery planning and assessment or support of a potential CRO transition.
No. Henley is independent and receives no fees, commissions or referral payments from CROs.
Recommendations are based on the requirements of the programme and our assessment of the available options.
Whether you are preparing to outsource a clinical programme, selecting a CRO, comparing proposals, approaching contract signature or concerned about an existing CRO relationship, we would be happy to talk.
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