Redefining Site Feasibility: A Call for Clarity and Collaboration

By Andrea Bastek, Vice President, Market Strategy

Site feasibility is meant to confirm whether a site can execute a protocol effectively, but the process is increasingly misaligned with the realities of study startup. Three emerging challenges are creating avoidable delays and eroding site trust. First, feasibility is often launched before the protocol is finalized, leading sites to provide projections that no longer match the final study requirements. When key details — like lab handling, imaging qualifications, or pharmacy equipment — surface at the SIV, teams face rework in staffing, budgeting, and contracting.

Second, CROs are initiating feasibility before receiving a study award. Sites invest significant time in questionnaires without knowing whether the opportunity is real, and some even receive duplicate pre‑award requests from competing CROs. This creates inefficiency and a growing transparency gap.

Finally, communication remains slow and inconsistent. Without clarity on what is final, which timelines are shifting, or how decisions flow across stakeholders, each party misallocates resources and weakens enrollment planning.

A more structured, phased approach, supported by clearer boundaries and better transparency, can reduce redundancy, improve accuracy, and restore feasibility’s role as a true accelerant to startups.