Land small, then expand. Run one study on Capture outside your main enterprise EDC contract, judge it on real work, and decide with evidence. The sandbox is free, so the evaluation starts before procurement does.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Build time
Draft from protocol
UAT status
In sandbox
The idea of a pilot on Capture
Why pilot
Clinical operations teams at larger sponsors are often under two pressures at once. Enterprise EDC is the standard for core programmes, with all the build cycles, change-order processes and vendor management that implies. Meanwhile some studies do not fit that machine well: an early-phase study with a short timeline, an investigator-initiated or translational study, a study with a patient-reported primary outcome, a study in a region or setting where heavy site training is hard. Teams need a lower-friction way to run those studies without opening a platform procurement project each time.
A pilot answers that. You pick one study that is genuinely suitable, keep your standards, and use Capture as the data-capture system for it. Everything that makes the study auditable stays: a field-level audit trail, role-based access, edit checks, queries, electronic signatures and SDTM-ready exports. What goes away is the long start-up path, because you build the study yourself, or let the AI study builder draft it from the protocol, and test it free. Capture suits Phase 1, 2 and 3, so the pilot can match the phase of the study you actually have.
The pilot path
A pilot does not need a long contract before the study team can touch the product.
Pick a protocol with a bounded scope: a Phase 1 or 2 study, or a Phase 3 study that is separate from your core programme. Name the people who will judge it: data management, biostatistics, quality, a site lead.
Decide what good looks like before you start. Examples: time from protocol to a testable build, number of queries handled without help, site coordinator feedback, whether the export fits your analysis workflow, whether the documentation answers your quality team.
Upload the protocol and review the AI draft, or build manually. Run user acceptance testing with dummy participants: skip logic, edit checks, auto-queries, e-signatures, the audit trail, blinded roles, exports. See the EDC UAT sandbox guide.
Enterprise customers receive documentation supporting sponsor validation and UAT, plus training and implementation assistance. Agree with your quality function what it needs to see and ask for exactly that.
Approved forms lock for live use. Sites enter data; the study team queries, monitors and exports. Cost starts only now.
Score the pilot against the criteria. If it met them, the next study is a repeat of a process you already know.
Testing
The sandbox is the full product: the same eCRF builder, edit checks, queries, e-signatures, audit trail and exports you would use live. Your own quality and data management staff can run scripted tests against it, with sample data, long before any commercial discussion. Because nothing is gated, there is no demo-only feature set to discount.
Pre-launch readiness
1 site activated
1 form not yet approved
Open the sandbox, load a protocol and let your data management team try to break it.
Success criteria
These are examples of measurable criteria, not thresholds Capture promises.
| Area | What to measure | Where to look in Capture |
|---|---|---|
| Build | Elapsed time from protocol to a build your team accepts in UAT | AI study builder, form lifecycle (draft to approved) |
| Data quality | Queries raised automatically versus manually; time to resolve | Edit checks, query dashboard |
| Sites | Training needed, coordinator feedback, time to first participant | Site coordinator portal, QR enrollment |
| Blinding | Whether blinded roles ever receive arm-level values | Blinded roles, masked views |
| Export | Fit with your analysis workflow; SDTM mapping effort | CSV/Excel with data dictionary, SDTM XPT + Define-XML |
| Oversight | Audit trail completeness, e-signature behaviour | Field-level audit trail, signature records |
| Documentation and support | Whether quality gets what it needs; response times | Enterprise documentation for sponsor validation and UAT; support |
Which study
The best pilot is a study that is representative enough to teach you something but contained enough to be safe to learn on. Early-phase studies with a handful of sites suit this well; see EDC for Phase 1 trials and multi-site early-phase trials. Studies with participant-reported primary endpoints are a good test of the ePRO side. A study at the edges of your usual vendor footprint, such as a region or a partner organisation, tests how little site training is needed.
Avoid choosing the most politically sensitive study in the portfolio, or one that is already mid-build in another system. Moving a study between systems mid-flight is a different exercise; see how to switch EDC vendors mid-study. Also avoid a pilot so small that it cannot exercise queries, roles and exports. For broader context on judging platforms, read the EDC vendor comparison guide.
Quality and IT will ask for evidence. Start from the security questionnaire guide and the computer system validation overview. Capture describes its controls as 21 CFR Part 11 aligned and its infrastructure as GDPR and HIPAA ready, hosted in the EU (Frankfurt) or the USA (N. Virginia). It does not currently claim SOC 2 or ISO 27001 certification, so tell your quality team that at the start rather than the end.
No. A pilot is one study run on Capture alongside whatever you use elsewhere. We do not comment on any other vendor's contract terms; your own agreements govern those.
Capture suits Phase 1, 2 and 3. Choose the study that fits your goal and is separate enough from your core programme to be a clean test.
The full sandbox, and for enterprise customers, documentation to support sponsor validation and UAT, along with training and implementation assistance. Tell us in advance what your quality function needs.
No. Capture describes its controls as 21 CFR Part 11 aligned and its infrastructure as GDPR and HIPAA ready, with EU and US hosting. Raise any certification requirement early.
Yes. CSV and Excel exports include an automatic data dictionary, and SDTM datasets can be exported as SAS XPT files with Define-XML. See the export guides linked on this page.
No. The sandbox includes every feature with no credit card and no time limit. You pay only once you go live with real participants.
Yes. Blinded roles never receive treatment-arm values, enforced by masked database views and row-level security rather than only in the interface.
Load a protocol, run your own UAT and decide on evidence. You pay only once a study goes live.