EDC for pilot clinical trials: small cohorts, rapid build, and 21 CFR Part 11–aligned controls for feasibility and pilot studies.
21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required
One of the goals of a pilot is to reduce operational risk for the main trial. By running your pilot on Capture, you can test visit schedules, data collection patterns, and site workflows in the same application you plan to use later. When you move into the main trial, you can keep what worked, adjust what didn’t, and know that your team is already familiar with the platform. This is especially helpful when your pilot introduces new elements—such as remote visits, ePRO instruments, or complex lab workflows—that you plan to scale later.
The way you configure pilot trials in Capture is consistent with the broader patterns described on the home, features, and early-stage solution pages: a browser-based builder for forms and visits, eConsent when needed, optional ePRO, and a single audit trail for safety and operational data. This means your teams do not have to learn a new tool just for pilots—they use the same Capture.Study patterns they apply to Phase 1, early Phase 2, and academic studies, but on a smaller, faster scale.
Overview
Pilot clinical trials test feasibility, procedures, and early signals in small cohorts before larger studies. They are often the first time a new workflow, assessment battery, or remote visit pattern is exercised in a real-world setting, and they frequently lead directly into larger Phase 2 or registration programs. In practice, that might look like piloting a new ePRO instrument alongside standard clinic visits, trialing a hybrid visit schedule that mixes on-site and remote assessments, or validating that a complex sampling schedule is operationally realistic. Your EDC must support rapid build, simple amendments, and full auditability without the cost of systems built for large trials. It should make it easy to stand up a small, focused study in weeks, capture the data you need to answer feasibility questions, and, if the pilot is successful, reuse most of the configuration for the follow‑on study. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so you can run pilot studies efficiently and scale when you’re ready, using the same familiar web interface shown across the Capture.Study site.
Pilot studies are often small, short, and iterative. You need an EDC that can go live quickly, capture consent and safety with full audit trails, and adapt if the protocol changes—without enterprise pricing or long implementation. At the same time, many pilot studies are used to make decisions that matter: whether an operational model is viable, whether a signal is worth pursuing, or whether to move into a larger program. That means you still need a system that can produce clean, auditable data, even if the scope is limited. Sponsors and partners may expect to see that your pilot data were captured in a controlled environment with appropriate access controls and documentation. Capture is built for this: one platform, rapid build, and controls aligned with 21 CFR Part 11 for when regulators or sponsors require documented systems.
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