EDC platform review
TrialKit review
TrialKit is a cloud eClinical platform built around EDC, available on the web and as native iOS, Android and Mac apps, with modules for ePRO/eCOA, eConsent, RTSM, eSource and imaging. It is used by sponsors, CROs and research sites for site-based, hybrid and decentralised trials; the vendor reported over 8,000 studies deployed in 2023.
- Our score
- 7.4/10
- Best for
- Studies collecting data on phones and tablets, including offline
- Pricing
- Subscription packages scaled by concurrent studies (e.g. Pilot tier for one live study); unlimited sites and users
- Vendor
- Crucial Data Solutions, Inc., Reno, Nevada, USA
Unique feature
Mobile-native EDC apps
The vendor calls TrialKit 'the only mobile-native EDC', with EDC, ePRO and eConsent running in native iOS, Android and Mac apps as well as on the web.
Fit
Who TrialKit suits
Best for
- Studies where sites or participants enter data on tablets and phones
- Hybrid or decentralised trials combining EDC, ePRO and eConsent
- Sponsors or CROs running many concurrent studies on one subscription
Less suited to
- Teams wanting published list prices
- Users wanting inferential statistics inside the tool
- Organisations that need a free tier or open trial
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 databaseSubscriptions include a first study build by the vendor (G2 listing)
- ✓Build forms yourselfNo-code drag-and-drop study builder with AI-assisted form generation
- ✓Audit trailVendor states 'complete audit trails'
- ✓Electronic signaturesElectronic signature listed on Capterra; vendor docs cite Part 11
- ✓Edit checks at data entryEdit checks in form builder; real-time validation at entry
- ✓Queries and source data verificationIntegrated query management; SDV not explicitly described
- ✓RandomisationRTSM module integrated within the TrialKit platform
- ✓ePRO and participant self-entryePRO/eCOA via mobile apps; provisioned devices or BYOD
- ✓eConsenteConsent module on the same platform
- ✓Offline mobile data collectionVendor says source data capture works 'online or offline'
- ✓Forms in several languagesVendor cites multilingual support; iOS app lists 19 languages
- ✓CDISC export (ODM / SDTM)CDISC ODM 1.3 export of metadata, data or both
- ✓Built-in reports and dashboardsStandard reporting and dashboards
- ?Built-in statistical analysis
- ?Numbered tables, figures and listings
- ✓APIAPI integrations, including EHR-to-EDC API
- –Free or open-source optionNo free trial (G2); sandbox for vetted organisations (Capterra)
Verdict
Strengths and limitations
Strengths
- Native mobile apps for site and participant data entry
- EDC, ePRO, eConsent and RTSM on one platform
- Capterra reviewers note ease of use, quick builds and responsive support
Limitations
- No published pricing
- Vendor lists ISO 27001 and SOC 2 as standards followed, not certificates held
- Some Capterra reviewers mention slow loading on large studies and limited reporting
Details
Pricing, hosting and regulation
Pricing
Subscription packages scaled by concurrent studies (e.g. Pilot tier for one live study); unlimited sites and users. Published prices: not published. Pricing source.
Hosting and security
Hosting regions: EU (Ireland, Paris) and US (Ohio, Oregon) AWS regions, chosen per study (vendor support page, list dated 2020). Vendor-hosted on AWS; hosting region is set in the licence agreement. No self-hosting option stated.
Certifications: AWS ISO 27001, 27017, 27018, SOC 1/2/3, HDS and C5 (hosting provider).
Regulatory support
Vendor names 'FDA 21 CFR Part 11, HIPAA, and GDPR' as compliance standards for TrialKit.. Whatever the software offers, your own procedures, validation and training are still needed for a regulated study.
Scale and set-up
Vendor says it supports trials from small biologics studies to large Phase 3 trials, multi-site or global; enterprise pricing covers 10 to 200+ concurrent studies.. Self-service no-code builds; vendor claims studies deploy 'in days not weeks', with setup support in the first 90 days and a first build by the vendor included..
Alternatives
Alternatives to TrialKit
Medrio EDC
Biotech and device sponsors wanting a fast no-code build.
Score 7.4/10 · Unique feature: No-code build aimed at rapid go-live
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
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
- Crucial Data Solutions: TrialKit EDC
- Crucial Data Solutions: TrialKit EDC system
- Crucial Data Solutions: TrialKit for site-based clinical trials
- Crucial Data Solutions: platform overview and pricing model
- TrialKit support: Compliance, Data Storage, and Security
- TrialKit support: Form Data Exports (CDISC ODM)
- Crucial Data Solutions corporate brochure (2022)
- Business Wire: enterprise subscription pricing announcement (July 2023)
- Clinical Leader: TrialKit AI study simulation (April 2026)
- Apple App Store: TrialKit - eClinical Platform
- Capterra: TrialKit reviews
- G2: TrialKit pricing