Resourcing Your Clinical Trial
Resourcing a clinical trial is one of the most critical things to get right. The protocol can be 'perfect', the sites top performing, and subject selection appropriate. However, if you don't have a solid clinical team executing the study from stats, data management, CRAs, project management, and safety, then all that effort up front may still lead to data that is not evaluable and/or regulatory compliant.
The options for resourcing a clinical trial are varied, and no one size fits all exists. Through my experience at large and small Sponsor companies and CROs, I have operationalized many of these options. These options can be put into three main buckets – although there are numerous variations within them – fully outsourced, entirely internal team, or a hybrid of internal and outsourced. The task is figuring out which of these fits best for your program and then, if appropriate, selecting vendors that take careful consideration, planning, and execution.
Some of the things I take into consideration when looking at the best model for resourcing a clinical trial include but are not limited to:
- The current size and capabilities/resources of the sponsor company
- The number and complexity of trials that the sponsor company is planning on running
- The geography or geographies of the study or studies
- The complexity of the therapy and patient population
- The overall clinical strategy, such as what future studies are planned and in what timeline
- The financial position of the sponsor company
The first piece I aim to understand is the complexity of the therapy and the patient population. Understanding the complexity of the study will, in turn, the specialization required of the clinical team. Indeed, there are CROs out there that have strong and specialized teams. Still, if the therapy and the patient population are complex, there will be a greater desire to have at least some of the clinical team be internal and have that deep specialization. It might be worth noting here that I consider an 'internal' resource to be anyone who reports directly to and acts entirely on behalf of the sponsor company. This internal resource could be an employee or a consultant.
The next area I focus on is the Sponsor company's current capabilities. This evaluation includes reviewing existing roles such as CRAs, Field Clinical Engineers, and Project Managers, as well as the geographic reach relative to the clinical strategy. This is a gap analysis that starts to set the strategy of which roles need to be filled, including determining the split between internal and external resources. The deliverable here is a Resourcing Plan.
Once a Resourcing Plan is in place, the next big step is filling those roles. For this discussion, I will focus on external vendors. There is no shortage of CROs, from small niche CROs focused on a geography and/or disease state to large global CROs. Which is the right fit for your program could be either something in between or both. Which is the best fit often comes down to the size/phase of the trial, the number of sites and geographies, and the overall resourcing plan (which roles are you keeping in-house). When looking at multi-national studies, while I have gone back and forth on this throughout the years, my current position is preferring a single provider that can cover all geographies when most of a study's operations are being resourced to a CRO. I will save the complete discussion on the selection process for another piece, but to summarize, it will be critically important to have resources on your side, employee or consultant, that can both manage the process from RFI to RFP to Bid Defense to selection and understands the in-and-outs of CROs to review proposals, budgets, and contracts.
Realizing I could continue this topic for a long time, I will close by saying that getting your clinical team right is critical but also one of the many trial operationalization pieces that I enjoy most. Few things are as rewarding as putting together and being part of a great team.
If you would like input on putting together a Resourcing Plan or assistance in the vendor selection process, please don't hesitate to reach out. I would love to discuss this topic further with you.
