EDC platform review
secuTrial review
secuTrial is a browser-based EDC system from interActive Systems for clinical trials, non-interventional studies and patient registries. It is used mainly by academic clinical trial units and university hospitals in Germany and Switzerland, as well as by pharmaceutical companies and CROs.
- Our score
- 6.0/10
- Best for
- Academic multicentre trials in Germany and Switzerland
- Pricing
- Per-user pricing on request
- Vendor
- interActive Systems GmbH (iAS), Berlin, Germany
Unique feature
Common EDC across Swiss academic research centres
Geneva University Hospitals states secuTrial has been adopted by nearly all clinical research centres in Switzerland, and recommends it for medium-to-high complexity or high-risk studies.
Fit
Who secuTrial suits
Best for
- Investigator-initiated drug or device trials run through academic trial units
- Patient registries and non-interventional studies needing audit trails and e-signatures
- Multicentre studies at German-speaking or Swiss institutions
Less suited to
- Teams wanting transparent online pricing
- Studies that require confirmed offline mobile data entry
- Users wanting inferential statistics inside the tool
Features
Key features
What the vendor documents publicly, checked against its own pages. “Not stated” means we could not confirm it, not that it is missing.
✓ Yes◐ Partly+ Add-on– No? Not stated
- ?Vendor builds your databaseAcademic units (DKF Basel, KKS Oldenburg) build databases for their researchers
- ✓Build forms yourselfCapterra reviewer: whole study can be set up in-house
- ✓Audit trailStated by university pages and DZHK user manual
- ✓Electronic signaturesElectronic signature stated by university pages and DZHK manual
- ✓Edit checks at data entryPlausibility checks on formats, logic and value limits
- ✓Queries and source data verificationQueries, configurable SDV with history, review and freeze steps
- ✓RandomisationThird-party directory cites seven algorithms; lists can be imported
- ✓ePRO and participant self-entryThird-party directory cites mobile apps for PROs; vendor site not reachable
- ?eConsent
- ?Offline mobile data collection
- ◐Forms in several languagesInterface in German and English (DZHK manual, 2018)
- ?CDISC export (ODM / SDTM)Third-party directory mentions 'CDISC interfaces'; format unconfirmed
- ✓Built-in reports and dashboardsReports and graphical patient-count statistics (DZHK manual)
- ?Built-in statistical analysis
- ?Numbered tables, figures and listings
- ✓APISOAP web service API described in JOSS 2020 paper
- ?Free or open-source optionCapterra lists a free trial; no free version found
Verdict
Strengths and limitations
Strengths
- GCP-oriented workflow: audit trail, e-signatures, SDV, review and freeze
- Established in academic trial units, with open-source R tooling for exports
- German vendor; third-party directory reports hosting in Germany
Limitations
- No published pricing on vendor site
- Interface languages limited to German and English in 2018 manual
- Capterra reviewer notes some features are 'not up to date'
Details
Pricing, hosting and regulation
Pricing
Per-user pricing on request. Published prices: Not published on vendor pages checked; Capterra lists a starting price of €800 per user, with a free trial. Pricing source.
Hosting and security
Hosting regions: Germany (vendor hosting in Nuremberg, per third-party directory). Vendor-hosted SaaS is listed; the University of Oldenburg runs secuTrial on servers in its own data centre, while one directory says no self-hosting. Confirm on-premise options with the vendor.
Certifications: None stated by the vendor.
Regulatory support
Vendor-supplied Capterra text claims 'full GCP and FDA 21 CFR Part 11 compliance'.. Whatever the software offers, your own procedures, validation and training are still needed for a regulated study.
Scale and set-up
Used for single and multicentre trials, registries and non-interventional studies; Geneva University Hospitals recommends it for medium-to-high complexity or high-risk studies.. Configured by customers or by academic trial units, which build validated study databases on request. Build times not stated..
Alternatives
Alternatives to secuTrial
Castor EDC
Self-built academic and MedTech studies, with UK, EU, US or Australian hosting.
Score 7.5/10 · Unique feature: Choice of EU, UK, US or Australian hosting
OpenClinica
Small to mid studies wanting published prices or open-source software.
Score 7.7/10 · Unique feature: Open-source Community Edition
ResearchGuru EDC
Teams that want the database built for them, with TFLs and analysis included.
Score 8.6/10 · Unique feature: EDC, automated TFLs and automated analysis in one platform
- Capterra: secuTrial (vendor-supplied description and review)
- University of Oldenburg: secuTrial service
- Otto von Guericke University Magdeburg, IMDS: secuTrial
- Geneva University Hospitals (HUG): software made available
- DKF Basel: data management services
- DZHK: secuTrial user manual (2018)
- Wright et al. secuTrialR, Journal of Open Source Software (2020)
- randotools R vignette: exporting randomisation lists to secuTrial
- European Purpose: secuTrial directory entry
- FitGap: secuTrial
- secuTrial in the European Purpose directory