Redefining Site Feasibility: A Call for Clarity and Collaboration

Three emerging challenges with site feasibility

1. Site feasibility is starting too early, and that causes downstream delays 

Site feasibility is often being initiated before the protocol is finalized. Ostensibly the reason is to accelerate timelines to First Patient In (FPI) by bringing site selection earlier in the planning process. In reality, sites report that sponsors are using these early feasibility responses to gather feedback to optimize and finalize the protocol. The problem is obvious once you see it in practice: sites are not asked to update their feasibility responses once the protocol details are finalized, meaning that their responses about enrollment projections, resource availability, and operational readiness may not be accurate for the final protocol details. The paper gives concrete examples of critical details that show up late (often at the SIV):

• Lab processing requirements (e.g., a refrigerated centrifuge for PK samples)
• Local vs. central lab requirements
• Pharmacy handling requirements that require specific equipment
• Imaging qualification steps, special equipment, vendor constraints

When final details like these emerge later during startup they can cause major delays in staffing and facility planning, which can cause delays or rework on budgeting and contracting. The task force notes many sites don’t even realize this trend is occurring yet, while sponsors/CROs may attribute the resulting delays to “slow sites,” rather than a flawed site feasibility process.

2. CROs are engaging sites before they even have the study award

A second emerging pattern: CROs are initiating feasibility before securing the sponsor contract, often to strengthen a bid or to be ready to move fast if awarded the study. From a site perspective, this can seem like a “business as usual” site feasibility questionnaire that they devote time to without realizing the opportunity is uncertain. Some sites even reported getting the same pre-award feasibility from multiple CROs bidding on the same study. Site feasibility is a time consuming process for sites and this risks wasting site time and effort if a study is not awarded. The paper emphasizes that many sites and sponsors are not aware this is happening, pointing to a critical transparency gap. Sites suggest asking CROs what the award status of the study is BEFORE completing the feasibility process.

3. Communication is too slow, unclear, and fragmented

The third challenge is less flashy but arguably the most damaging: lack of clear, timely communication across stakeholders, especially when a sponsor, CRO and site are all involved. Site feasibility is most effective only when everyone is operating with aligned assumptions about:

• What’s final vs what is still changing
• Study status (e.g., FDA submission, expected amendments)
• Timelines and milestones
• Communication channels

When those things aren’t communicated, every party misallocates resources:

• Sites can’t prioritize their pipeline accurately
• Sponsors/CROs can’t plan staffing and timelines confidently
• Enrollment projections become unreliable.

What “good” looks like: feasibility with clear boundaries and phased work

Protocol feedback should happen through formal consulting, before starting site feasibility

If sponsors want operational input from experienced sites to optimize protocol design, the task force recommends doing this during Study/Protocol Feasibility via early stakeholder engagement—and using formal, paid consulting agreements, not feasibility questionnaires.

Why? Because “free” feasibility work isn’t the right mechanism for protocol design feedback, and it creates costly downstream delays when a protocol isn’t final.

Split site feasibility into phases

Instead of repeating the same questions for every study, the task force recommends structuring site feasibility into four phases:

1. Site Profile
2. Site Capabilities
3. Site Performance
4. Protocol-Specific Assessments

The idea is simple:

• Collect the stable information (profile/capability/performance) earlier, or leverage technology that offers persistent site intelligence to have real-time access to this information
• Conduct protocol-specific feasibility assessments after all critical documents are finalized

This shift would reduce redundant work while improving the accuracy of site feasibility.

A practical checklist: what should exist before protocol-specific feasibility starts

The paper also includes a “minimum necessary” checklist of materials to initiate protocol-specific feasibility, such as the finalized protocol, manuals (draft or final), central lab requirements, CRFs/eCRF guidance, budget template, vendor/system list and projected timelines.

This checklist matters because it creates a critical path dependency for site feasibility: if these items aren’t available, feasibility responses are predictably wrong and the trial pays for it later in amendments and rework.

The takeaway: feasibility can’t be a shortcut without consequences

Feasibility is often treated like an administrative hurdle. The SEL task force makes the case that it’s much more than that: feasibility is now a major upstream driver of startup delays, enrollment risk, wasted cost, and site dropout, especially when feasibility is rushed.

Fixing it doesn’t require perfect industry-wide standardization. But it does require:

• Clearer boundaries between protocol optimization and site selection
• Phased feasibility that reduces redundancy
• Transparency about what’s known vs not yet final
• More disciplined, faster communication loops

If we do that, feasibility becomes what it was meant to be: a facilitator, not a bottleneck.