Plan Patient Interviews to Strengthen Trial Data Readiness

Don't accept the claim at face value. Ask them to demonstrate understanding across every step of the interview lifecycle, through a structured approach rather than a general proposal. A request for proposal is the right tool here, because it forces a detailed explanation of how they plan to do the work, not just an assurance that they will. Your audit teams also need to assess the provider. And qualifying a vendor for one part of a clinical trial doesn't mean they know how to run in-trial patient interviews. CLINIGMA's RFP template sets out exactly what to require and what evidence to ask for.

It's easy for a provider to say they have a system that can do the job. It might even be a validated system, such as an EDC used to capture trial data. But validated doesn't mean fit for purpose: a system can pass a paper-based validation exercise and still not be suitable for conducting and processing patient interviews. Ask what the system was validated for. A general-purpose meeting tool like Teams or Zoom may be described as validated, yet still not support the requirements that matter here, such as controlling where interview data is processed and stored. If your trial requires data processing within a specific region, a tool that cannot guarantee that is not fit for purpose, whatever its validation status. One thing is to claim it. Another is to show it.

A specialist has a much easier time staying aware of the pitfalls, particularly around local data-privacy regulations and how they're interpreted in individual countries, Italy being a good example. For a specialist, this is the core business. For a large CRO offering interviews as one service among many, it rarely gets that level of attention.