Capture.Study vs SMART-TRIAL: A General EDC vs a Medtech Specialist
SMART-TRIAL is now marketed as Greenlight Guru Clinical, following Greenlight Guru's 2022 acquisition; we use both names here since teams still search for SMART-TRIAL. It is an EDC purpose-built for medical device and diagnostics studies, IDE and PMCF, aligned to FDA, EU MDR, IVDR and ISO 14155, per its own site. Capture.Study is a general-purpose self-serve EDC, eConsent and ePRO platform used across therapeutic areas. Here is where each fits.
Who This Comparison Is For
This page is useful if:
You're running a medtech IDE or PMCF study
- Want a platform purpose-built around FDA, EU MDR, IVDR and ISO 14155
- Greenlight Guru Clinical's stated specialty
You want a broader self-serve platform, not medtech-exclusive
- Your studies span more than medical devices, or you're not sure yet
- Want to see real functionality before an onboarding call
Quick Comparison Table
| Feature | Capture.Study | SMART-TRIAL (Greenlight Guru Clinical) |
|---|---|---|
| Self-serve free sandbox, no sales call to start | Guided onboarding, typically live within about 14 days per their own site | |
| AI drafts CRFs from a protocol or description | Not a standard feature | |
| eConsent included in the same platform | Included, per their own product page | |
| ePRO / eCOA included | Included, per their own product page | |
| Randomization (RTSM) included | Included, per their own product page | |
| Purpose-built specifically for medtech IDE / PMCF studies | Works for medtech, not medtech-exclusive | Yes, purpose-built for FDA/MDR/IVDR/ISO 14155, per their own site |
| 21 CFR Part 11-aligned controls | ||
| Broader fit across therapeutic areas beyond medical devices | Positioned specifically for medtech and diagnostics |
We built this table from Greenlight Guru Clinical's own public product positioning. If anything here is out of date, let us know.
Getting Started
Greenlight Guru Clinical (SMART-TRIAL) offers guided onboarding, with teams typically live within about two weeks per their own site. Capture.Study lets you build and test your full study in a free sandbox today, with no credit card and no onboarding call required to start, and you only pay once you go live.
Scope
Greenlight Guru Clinical was built from the ground up for medical device and diagnostics studies, IDE and PMCF surveys, and is aligned specifically to FDA, EU MDR, IVDR and ISO 14155, per its own public positioning. Capture.Study is a general-purpose EDC, eConsent and ePRO platform used across therapeutic areas, including but not limited to medical devices, with an AI study builder and drag-and-drop CRF builder that Greenlight Guru Clinical does not advertise.
Compliance
Both platforms position around 21 CFR Part 11-aligned controls. Greenlight Guru Clinical's compliance framing is specifically built around medtech regulatory pathways: FDA, EU MDR, IVDR and ISO 14155. Capture.Study provides a field-level audit trail that cannot be edited from the app, OTP-verified electronic signatures with countersignature, and role-based access, with documentation to support your own validation on Enterprise plans, applicable across therapeutic areas.
Pricing
Neither vendor publishes exact numbers; Greenlight Guru Clinical, like most specialist EDCs, quotes per engagement. Capture.Study's free sandbox lets you build and test the platform and see real functionality before paying anything, with paid plans that scale by study size once you go live.
When SMART-TRIAL (Greenlight Guru Clinical) Is Still the Right Choice
Your study is specifically an IDE or PMCF medtech study
A platform purpose-built around MDR, IVDR and ISO 14155 may be worth the specialization, especially if you already use Greenlight Guru's quality management tools.
You need guided onboarding rather than self-serve setup
Teams that prefer a guided implementation process over configuring the study themselves may prefer that model.
When Capture.Study Is the Better Choice
Your study isn't medtech-exclusive
A general-purpose EDC works across therapeutic areas without a medtech-specific framing.
You want AI-assisted CRF drafting and a broad template library
Upload a protocol or description and review an AI-drafted first pass, or start from an existing template.
You want to test the platform yourself before any onboarding call
Build and test your entire study in the free sandbox today, no credit card required.
Frequently Asked Questions
Is SMART-TRIAL the same as Greenlight Guru Clinical?
Yes. Greenlight Guru acquired SMART-TRIAL in 2022 and the product is now marketed as Greenlight Guru Clinical, per Greenlight Guru's own site. Teams still search for the original name, so we use both here.
Is Capture.Study a good fit for a medtech IDE or PMCF study?
Capture.Study is a general-purpose EDC, eConsent and ePRO platform used across therapeutic areas, including medical devices. Greenlight Guru Clinical is purpose-built specifically for medtech IDE and PMCF studies aligned to FDA, EU MDR, IVDR and ISO 14155.
Can I try Capture.Study before deciding?
Yes. The free sandbox includes every feature with sample data, no credit card and no time limit, so you can test it against your own protocol.
Is Capture.Study 21 CFR Part 11-aligned like Greenlight Guru Clinical?
Yes. Capture.Study provides a field-level audit trail, OTP-verified electronic signatures with countersignature, and role-based access control, with documentation to support sponsor validation on Enterprise plans.
See If Capture.Study Fits Your Study
Free sandbox with no time limit. Build your study and test everything before paying a dollar.
No credit card required. No sales calls.