FileMaker lets a team build a custom database quickly, and many research groups have done so. A study database also needs validation, an audit trail with reasons, e-signatures and access control. Capture ships those controls ready to test.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Tests
5
Hands-on
4
To confirm
1
Capture vs FileMaker: the short version
0
sales calls needed to start building
1
audit trail across EDC, ePRO, eConsent and randomization
Free
sandbox with every feature, no time limit
EU + US
hosting in Frankfurt or N. Virginia
The wedge
Low-code database tools are attractive for clinical studies because the protocol never quite matches an off-the-shelf template. A developer or a data-literate coordinator can lay out the forms, add calculations and have a working database within days. For tracking supplies, contacts or small observational registries, that speed is a real advantage.
The trouble starts with what a regulated study needs on top of the layouts. Each value should be attributable to a user and a time, each change should carry a reason, queries should be raised and resolved on record, signatures should carry a meaning, and the structure should not change unnoticed once data are going in. In a custom build, each of those is something your team designs, scripts and tests, and then re-tests after every change. The validation of the system is your documentation, and a departure of the developer leaves the system, and its history, in the hands of whoever remains.
A purpose-built EDC changes where that work sits. In Capture, field-level audit trail, edit checks that raise auto-queries, a draft to approved form lifecycle and role-based access are already part of the product, and forms are the only thing your team has to build. Part 11 compliance remains a shared responsibility with your own validated use, but the number of controls you have to engineer from scratch falls sharply.
Not every project needs an EDC. A non-regulated registry, a lab inventory or an internal logistics tool can sit comfortably in a custom database. The line is crossed when the data will support a regulatory, ethics or publication decision, when participants consent to a defined process, or when someone outside your team will want evidence of how the data were handled. For other build-it-yourself options see Capture vs Microsoft Access and Capture vs Airtable.
What to compare
| Criterion | Why it matters | Capture |
|---|---|---|
| Audit trail | Who changed what, when and why | Field-level, append-only, with user, time, old and new value and reason; exportable |
| Who builds the controls | Effort, cost and risk | Controls are part of the product; your team builds forms, visit schedule and edit checks |
| Data checks | Clean data at entry | Range and custom-value edit checks raise auto-queries when a site enters a value that breaks a rule |
| Signatures | Consent and investigator sign-off | Verified eConsent; re-authenticated investigator signatures with a meaning statement |
| Locked structure | Forms that cannot change unnoticed mid-study | Draft and approved forms; approved forms locked for live use |
| Validation | Evidence the system works as intended | Free sandbox to test skip logic, edit checks, e-signatures and the audit trail before going live; enterprise customers receive documentation to support sponsor validation and UAT |
| Access control | Minimum necessary access by role | Researcher, site coordinator and admin roles; PII segregation; row-level security |
| Multi-site entry | Several sites on one database | QR-code enrollment, separate site coordinator portal, by-site filtering and exports |
| Data export | Analysis-ready datasets and a data dictionary | CSV or Excel with an automatic codebook; SDTM as SAS XPT with Define-XML |
| Commercial model | Budget for a small study | Free sandbox with every feature; no setup fee; pay only when you go live |
This table shows Capture's answers only. Ask FileMaker for theirs, and confirm current capabilities and terms directly with them.
Compliance controls
Every change is written to an append-only, hash-chained audit trail with user, time, old and new value and reason. Electronic signatures require password re-authentication and carry a meaning statement. Roles separate sites, and identifying data is segregated from study data at the database layer.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Longitudinal studies
Each visit is anchored to screening, a milestone, an earlier visit, a fixed study day or a date recorded on a form, with a window and an enforcement mode. Questionnaires follow the schedule, reminders go out by email or SMS, and the status overview shows every participant against every visit.
Window -3 / +3 days around the anchored target date
Soft window
Stays available with a protocol deviation flag
Hard window
Locks outside the window
Warning only
Stays available with a warning
Auto-close
Marked missed when the window closes
Describe it or upload it, and let the AI draft the questions in the free sandbox.
Fit
FileMaker is often the right choice for custom internal applications, non-regulated registries and tools where a skilled in-house developer will maintain the build and the data are not subject to a regulatory audit trail. Ask Claris what documentation it provides for regulated use.
Capture fits studies that need to show how data were entered, changed, queried and signed without building those controls. It suits teams without a dedicated developer, and studies that may be audited, from Phase 1 to Phase 3.
Identity and access
Site coordinators see participant names; researchers and sponsor-side users work with coded IDs. Identifying data is segregated at the database layer, sites see only their own participants, and data is encrypted with AES-256 at rest and TLS in transit, hosted in the EU or US.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
Switching
Export your layouts and field list. Describe the form or upload it and Capture's AI drafts the eCRFs for review; nothing is saved without human approval. Add edit checks and visit schedule, then approve the forms to lock them.
Archive the existing database as it stands, with its scripts and documentation, rather than editing it after the cut-over. Start new collection in Capture on a defined date and record the cut-over in the data management plan.
Rebuild any calculations you relied on: Capture supports calculated fields such as BMI, BSA, eGFR and QTc, shown read-only during entry. Test the whole flow free in the sandbox first.
Evaluation
Agreements, access control and hosting checked.
Schedules, windows and reminders needed.
Audit trail with reasons required.
Consent or investigator sign-off needed.
Site separation and roles needed.
Part 11 or GCP expectations apply.
All comparisons
Every comparison uses the same approach: what to test, where each option fits, and Capture's own answers. See all of them on the comparisons hub at /compare.
It can store and display study data. Whether it is suitable for a regulated study depends on the audit trail, signatures, access rules and validation evidence that your team builds and documents, and on what your sponsor or regulator expects.
Part 11 compliance depends on the implementation and on how the sponsor validates and uses it, not on a product name alone. Ask Claris for its current guidance and plan to produce your own validation documentation.
An EDC ships the regulated controls (audit trail with reasons, edit checks, queries, signatures, role-based access, locked forms) as part of the product. In a custom build, your team designs and validates each of them.
That is the common risk with custom builds: scripts and layouts are understood by few people. With a configured EDC, the forms and rules are visible in the builder and changes are recorded.
Export to CSV or Excel and use the AI form builder to draft forms from the field list. Keep the original database archived as source documentation. Plan a documented migration with reconciliation for any data you carry over.
Yes. The sandbox has every feature, no credit card and no time limit. You pay only once you go live with real participants.
Yes. The free sandbox includes every feature with sample data, no credit card and no time limit. You pay only when you go live.
From public positioning and the criteria teams tell us matter. We state only Capture's own capabilities as fact; confirm FileMaker's current offering with them.
Keep exploring
Capture vs Microsoft Access
Another build-it-yourself database.
Capture vs Airtable
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EDC validation checklist
What validation evidence looks like.
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Capture vs SurveyMonkey
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Build a study in minutes. Free sandbox.