Both are academic favourites with open or consortium roots, and both push validation questions back to you. This page compares who validates, who hosts and who supports, and adds a third option to test the same way.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| OpenClinica | REDCap | Capture | |
|---|---|---|---|
| Who validates for Part 11 | Ask vendor | Ask your institution | Documentation for your validation |
| Who hosts and patches | Ask vendor | Ask your institution | Hosted, EU or USA |
| ePRO and eConsent in the study | Ask vendor | Ask your institution | Yes, one audit trail |
| Who supports site users | Ask vendor | Ask your institution | Email support |
| Hands-on trial before commitment | Ask vendor | Often available | Free sandbox |
The short version
Two models
REDCap is a consortium model: your institution joins, runs the software and supports the users. That is a strength when the institution has a mature research IT team and a documented validated instance, and a risk when it does not, or when the project is a multi-site trial that spans institutions with different instances. Existing pages cover this in detail: REDCap vs EDC for clinical trials, REDCap hosting and validation burden and is REDCap 21 CFR Part 11 compliant.
OpenClinica started as open-source software and now sells a commercial cloud product alongside the community code. The practical question is which edition you would actually run, who validates it and who answers the phone. A community install may suit a team with its own engineering and validation capacity. A commercial tier shifts some of that to the vendor, with a cost you need to obtain as a quote. See OpenClinica alternatives.
Evaluation
Get the answers in writing, especially for anything touching validation.
| Topic | Question | What Capture offers for comparison |
|---|---|---|
| Validation | Who owns installation qualification and validation, and is there a current document we can show an auditor or sponsor? | Capture is 21 CFR Part 11 compliant on its product pages; compliance is shared with your own validated use. Enterprise customers receive documentation to support validation and UAT. |
| Hosting | Where is the data hosted, who patches it and who backs it up? | Hosted in the EU (Frankfurt) or the USA (N. Virginia). |
| Audit trail | Is the audit trail field-level, with reason for change, and can it be exported? | Field-level, append-only; timestamp, user, old and new value, reason; always exportable. |
| Participant data | How are patient questionnaires and consent handled, and are they in the same audit trail? | ePRO and eConsent share one study and one audit trail with EDC. Email-OTP e-signatures. |
| Multi-site | How are sites and roles separated, and how is access removed? | Roles, site-level numbering, QR enrolment, by-site filtering and a site coordinator portal. |
| Support | Who supports site coordinators on a Sunday before a visit? | Email support, typically under 24 hours; documentation and video tutorials. |
| Exports | What leaves the system at lock: data, dictionary, audit trail, SDTM? | CSV/Excel with a data dictionary; audit trail; SDTM as SAS XPT with Define-XML. |
| Cost | What is the full cost of hosting, validation effort, staff time and licences? | The pricing page lists current terms; the sandbox is free. |
Capture rows are from the Capture product pages. OpenClinica and REDCap columns are deliberately blank: ask the vendor or your institution.
Build a study in the free sandbox, test edit checks, e-signatures and the audit trail, and compare the effort with your current set-up. No card, no time limit.
Hands-on test
Whichever route you take, an auditor will look at the audit trail. Change one value in each system and look at what is recorded: who, when, old value, new value and the reason. This is a demo-data example of a change with a reason in Capture.
Event term
AETERMSeverity
AESEVChanged from Mild
ModerateReason for change
Who carries the work
Decision aid
REDCap may be the lowest-friction route for a single-site study; confirm the validation record.
Ask OpenClinica which edition and documentation applies.
Check whether all sites can use one instance and one validation.
Ask both; test Capture alongside.
Prioritise validation documents and audit trail export; see the academia page.
Switching
See how to migrate from OpenClinica, how to migrate from REDCap and common REDCap to EDC migration mistakes. Single comparisons: Capture vs REDCap, Capture vs OpenClinica, and REDCap alternatives. Academic teams can start at Capture for academia.
Neither is better in general. REDCap depends on your institution's instance and validation; OpenClinica depends on which edition you run. Ask who validates, who hosts and who supports before comparing features.
Sources describe REDCap as licensed at no cost to non-profit consortium partner institutions, installed and administered by the institution. Hosting, staff and validation effort are still costs; ask your institution.
OpenClinica publishes a Community edition and commercial editions. Its own comparison page says the Community edition comes without support or services and must be validated by the user. Check the current terms and ask for a quote for the commercial tier.
University sources say Part 11 compliance is shared between the software features and the institution's validated environment, and they differ in how they phrase it. See the dedicated Part 11 page and ask your institution for its validation record.
Because a hosted platform with a free sandbox removes the hosting and installation work that both routes involve, and puts EDC, ePRO, eConsent and randomization in one audit trail.
Yes. Capture supports Phase 1 through Phase 3, including SDV per field, freeze and lock, blinded roles and multi-site filtering.
Write down who validates, hosts and supports in each case, build one real visit in each, and compare the full cost including staff time.
Keep exploring
Build the same study in Capture, free. No credit card; you pay only at go-live.