EDC for Feasibility Studies

EDC for feasibility studies: site and protocol feasibility with 21 CFR Part 11–aligned data capture and audit trails.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

From feasibility insights to main trial design in Capture.Study

Because feasibility and main trial can both be run on Capture, you can carry forward what you learn during feasibility—site performance, recruitment assumptions, protocol pain points—directly into your main trial configuration. Instead of managing separate tools and spreadsheets, you keep a single source of truth for feasibility data and use it to refine inclusion criteria, visit schedules, and site selection in the main protocol.

  • Use feasibility results to refine site selection and site-specific enrollment targets for the main study
  • Adjust visit schedules or procedures in the main trial build based on operational feedback from feasibility
  • Align data structures between feasibility and main study to simplify cross-study analysis and reporting
  • Keep decision-making transparent by retaining audit trails and exports from feasibility within the same platform

Overview

EDC for Feasibility Studies

Feasibility studies assess site capability, recruitment potential, and protocol practicality before full trial launch. They often involve surveys or targeted data collection from potential sites and investigators, and they may include limited patient data when assessing recruitment patterns or operational constraints. Sponsors use feasibility work to answer questions like: Do our inclusion/exclusion criteria fit real-world patients? Which regions or site types are most likely to recruit on time? Are proposed visit schedules practical for patients and sites? Your EDC must support targeted data collection, quick setup, and full auditability without enterprise cost. It should also make it easy to transition from feasibility into the main trial—reusing site lists, site attributes, and lessons learned about recruitment when you move forward. Capture provides EDC, eConsent, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so you can run feasibility studies efficiently and use the same platform for the main trial when ready.

Why feasibility studies need the right EDC

Feasibility studies are often short and focused. You need an EDC that can be built quickly, capture site and protocol data with clear audit trails, and scale to the main study if needed. Enterprise EDC often adds implementation time and cost that doesn’t fit feasibility scope. At the same time, feasibility results frequently feed directly into sponsor and governance decisions about whether and how to run the main trial, so the data must be reliable and traceable. For some organizations, feasibility also underpins health authority or ethics discussions about protocol practicality. Capture is built for quick deployment and controlled data capture aligned with regulatory expectations, while still giving you a straightforward path to reuse work in the main study.

Common feasibility study workflow

  • Feasibility protocol and consent; ethics if required
  • Site identification and activation
  • Site and recruitment data collection (e.g., patient counts, investigator experience, operational constraints)
  • Protocol feasibility assessments; data review
  • Reporting and decision support for go/no-go
  • Optional transition to full study on the same platform, using feasibility insights to inform design

Traditional tool pain points

  • Heavy EDC implementation for short feasibility scope
  • Separate systems for feasibility vs. main trial
  • High cost for limited data collection
  • Limited auditability for regulatory or sponsor review
  • Difficulty reusing feasibility data structures and findings in the main trial build

How Capture supports feasibility studies

  • Rapid build for feasibility-specific forms and visits, including site surveys and recruitment assessments
  • Unified EDC with eConsent and safety; one audit trail when participant data are collected
  • 21 CFR Part 11–aligned controls for data integrity when feasibility findings inform regulated programs
  • HIPAA-aligned security; export for reporting and governance decisions
  • Same platform and configuration approach for main trial when you scale
  • Configuration patterns that make it easy to carry site attributes and feasibility metrics into the main study

Related

EDC for pilot trialsEDC for proof-of-conceptFeatures

FAQ

Questions we hear a lot

Can we use Capture for feasibility studies?
Yes. Capture supports feasibility studies with rapid build, targeted data capture, and full audit trails. You can run feasibility on the same platform you use for the main trial.
Do we need separate systems for feasibility and main study?
No. Capture can support both. You build a feasibility study first; when you’re ready for the main trial you can use the same platform and, if needed, extend the build. Data and audit controls are consistent.
What about compliance for feasibility?
Capture is designed with 21 CFR Part 11–aligned controls. If your feasibility data feeds regulatory or sponsor decisions, you have audit trails and access controls to support review.
Can we collect both site-level and limited patient-level data in feasibility?
Yes. You can configure forms to collect site metrics (e.g., patient counts, investigator experience) and, when appropriate, limited patient-level data, with the same audit and access controls applied.
How quickly can we stand up a feasibility study?
Study build can start as soon as you have a feasibility plan and data collection requirements. Many teams deploy feasibility studies in a matter of weeks, especially when they reuse forms and patterns from prior work.
Can feasibility and main trial be validated together?
Sponsors decide how to structure validation. Some treat feasibility as part of the same validation umbrella as the main trial; others validate feasibility separately. Capture’s controls and documentation can support either approach for Enterprise implementations.
Can external partners access feasibility dashboards or exports?
Yes. With appropriate roles and governance, you can share feasibility exports or limited access with partners, while keeping full control of the underlying configuration and data.
Does Capture help us compare feasibility across multiple potential indications or regions?
Because feasibility studies and site data are stored in one platform, you can export and compare feasibility metrics across indications, regions, or site types using your own analysis tools.
What happens to feasibility data if we don’t proceed to a main trial?
Data and audit trails remain available in Capture for as long as your retention policies require. You can still use the insights from feasibility in future protocol designs, even if a specific main trial does not proceed.
Can we archive feasibility configurations and reuse them later?
Yes. You can keep feasibility configurations as templates for future studies, copying and adapting them as needed when similar feasibility questions arise in new programs.

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