Independent clinical trial outsourcing advice for biotech companies before going to market.
The outsourcing model chosen for a clinical programme has important implications for cost, internal resourcing, sponsor oversight and how responsibilities are divided between the sponsor and its providers.
For emerging and growing biotech companies, the decision can be particularly important. Internal teams are often lean, while a significant proportion of clinical development may need to be delivered through CROs and specialist providers.
Henley helps biotech companies define their clinical trial outsourcing strategy before approaching the market: which activities should remain in-house, which should be outsourced, whether a full-service CRO, FSP or hybrid model is most appropriate, and what each option means for the sponsor's internal team and oversight responsibilities.
The objective is a clear outsourcing model, scope and set of assumptions that can be taken to potential providers, allowing CRO proposals and budgets to be evaluated on a more consistent basis.
Different outsourcing models create different commercial, operational and governance challenges.
Henley brings more than two decades of CRO industry experience, including full-service and FSP commercial models, pricing, proposals, contracts, strategic accounts and executive governance of clinical trials.
We use that experience on the sponsor's side of the table to help biotech teams understand the practical and commercial implications of different outsourcing approaches before committing to a provider or model.
Building the right clinical trial outsourcing model.
Defining what should be outsourced, what should remain within the sponsor and how responsibilities should be divided.
Assessing full-service, FSP and hybrid approaches against the requirements of the clinical programme and the capabilities of the internal team.
Defining scope and key assumptions clearly before approaching CROs and other providers, reducing ambiguity when proposals and budgets are compared.
Identifying the types of CROs and specialist providers appropriate for the programme and understanding the differences between available options.
For a biotech with a lean internal team, determining the right outsourcing model can require experience that may not be needed permanently within the organisation.
Henley can provide additional senior outsourcing support at this stage — helping the existing management and clinical team define the model, scope and requirements before approaching potential CROs.
Support can be focused on a specific decision or provided through the subsequent CRO selection, RFP, proposal review and negotiation process.
There is no single model that works for every biotech. The right balance depends on the clinical programme, the experience and capacity of the internal team, the capabilities required and how much operational control the sponsor wants to retain. The important distinction is between outsourcing activities and retaining sponsor accountability. Even where substantial parts of a programme are outsourced, the sponsor needs sufficient capability to provide effective oversight and make key decisions.
A full-service model can work well where a sponsor wants one CRO to manage a broad range of activities and has a relatively lean internal team. FSP can be appropriate where the sponsor wants to retain greater functional control or supplement existing internal capabilities with external resources. Hybrid approaches combine elements of both. The right choice depends on the programme, internal capabilities, pipeline, available resources and the level of control the sponsor wants to retain.
Ideally, before the RFP. Defining the outsourcing model, scope and key assumptions first makes it easier to ask CROs to bid against consistent requirements and to compare the resulting proposals and budgets. Where an RFP process has already started, these issues can still be clarified before final CRO selection or contracting.
Yes. Henley can continue through the subsequent CRO selection and RFP process, including identifying potential CROs, developing the RFP, reviewing and comparing proposals and budgets, supporting bid defences and commercial negotiations, and establishing governance following award.
If you are deciding what to outsource, considering different CRO models or preparing to approach potential providers, we would be happy to discuss your requirements. Initial conversations are confidential and without obligation.
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