Open source EDC gives you the code and control. It also gives you the hosting, security, upgrades and validation. Here is what open source means for clinical data capture, what it really costs, and when a hosted platform makes more sense.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Self-hosted open source | Hosted platform | |
|---|---|---|
| Software licence cost | None | Subscription |
| Hosting, backups, security patching | Your team | Vendor |
| Upgrades and testing | Your team | Vendor, with your UAT |
| Validation for intended use | Your team | Your team, with vendor documentation |
| Support | Community or contractor | Vendor |
The short version
Total cost
The software licence is often the smallest part of running an EDC. A self-hosted system needs servers or cloud hosting, backups and disaster recovery, security monitoring and patching, upgrades with regression testing, user administration, help desk support and training. For regulated studies, it also needs validation evidence that the system works as intended in your environment, repeated after significant upgrades.
Organisations with an established research IT team can absorb those costs across many studies, which is why open source and consortium-licensed systems are common in large academic centres. Smaller teams usually find that hosting, validation and support cost more than a subscription. See free EDC software for no-cost options more broadly.
Regulatory compliance depends on how a system is configured, validated and used, whoever wrote the code. With a self-hosted system, the sponsor or institution carries more of that responsibility directly. See computer system validation.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Comparison
| Model | Typical users | Main trade-off |
|---|---|---|
| Self-hosted open source | Institutions with research IT teams | Full control; your team runs and validates everything |
| Consortium-licensed (for example REDCap) | Academic and non-profit institutions | No licence fee; institution hosts and supports |
| Hosted commercial platform | Sponsors, CROs, academic teams without IT capacity | Subscription; vendor runs hosting, security and upgrades |
The hosted alternative
Capture is hosted in the EU (Frankfurt) or the US (N. Virginia), with AES-256 encryption at rest and TLS in transit. The free sandbox has every feature with no time limit, and you pay only when you go live with real participants. Data exports in open formats with a data dictionary, so you keep control of your data.
| SUBJ | ECGPERF_CODE | ECGPERF_LABEL |
|---|---|---|
| 01-001 | Y | Yes |
| 01-002 | ND | Not done |
Build a study in the free sandbox in less time than a server install.
Fit
Open source is a good fit when you need to modify the software itself, have policies that require self-hosting, or run many studies with a research IT team that already hosts and validates systems. It also suits some teaching and methodology research where access to the code matters.
It is a poor fit when the goal is simply to avoid a licence fee for one or two studies without IT support. In that case, the time spent on hosting, security and validation usually costs more than the licence saved. See REDCap alternatives and OpenClinica alternatives.
Before choosing
What it allows and requires.
Recent releases and security fixes.
Servers, backups and disaster recovery.
Patching, monitoring and access control.
Initial and after upgrades.
Who users call when something breaks.
A community-maintained open-source fork of an earlier OpenClinica version.
Yes. Data exports in open formats with a data dictionary, along with audit trails and signed documents.
Yes. Some EDC systems have open-source editions or community forks, such as LibreClinica. Check the licence and whether the project is actively maintained.
No. REDCap is available at no licence cost to non-profit consortium members under a licence agreement, but it is not open source.
The licence usually is. Hosting, security, upgrades, validation and support are not.
No. Capture is a hosted platform with a free sandbox; you pay when you go live.
Compliance depends on configuration, validation and use. With self-hosted software, your organisation carries more of that responsibility.
Yes. The free sandbox has every feature and no time limit.