EDC platform review
ResearchGuru EDC review
A managed electronic data capture (EDC) service: the ResearchGuru team builds and tests the study database from your approved protocol, questionnaire/form and informed consent form, then hosts and supports it. Numbered tables, figures, listings and statistical analyses are produced inside the same platform from the live study data.
This guide is published by ResearchGuru Ltd, which also makes ResearchGuru EDC. How we rank.
- Our score
- 8.6/10
- Best for
- Teams that want the database built for them, with TFLs and analysis included
- Pricing
- Quote per study (build, hosting and support); no minimum study size
- Vendor
- ResearchGuru Ltd, London, United Kingdom
Unique feature
EDC, automated TFLs and automated analysis in one platform
Saved tables, figures and listings (numbered 14.1.x, 14.2.x, 16.2.x) and inferential analyses, from t-tests and chi-square to Cox and linear mixed models for repeated visits, re-run on the current study data and export to Word, RTF, CSV or PDF. A small study team can go from data capture to report-ready outputs without a separate programming step.
Fit
Who ResearchGuru EDC suits
Best for
- Academic, investigator-initiated and small-to-mid clinical studies without an in-house data manager or programmer
- Observational studies, patient registries and post-market studies that need report-ready tables quickly
- Studies combining site-entered data with participant ePRO or eDiaries, in several languages
Less suited to
- Very large global Phase III programmes that need built-in IRT/drug supply or EHR integration
- Teams that want to build and change every form themselves with no vendor involvement
- Research on tobacco or nicotine products (the vendor does not accept this work)
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 databaseStandard: the vendor builds and tests the eCRF
- ◐Build forms yourselfChanges go through the vendor's change control
- ✓Audit trailField-level, reason for every change, hash-chained
- ✓Electronic signatures
- ✓Edit checks at data entryRange, date and consistency checks at entry
- ✓Queries and source data verificationQueries, SDV and study lock
- ✓RandomisationPermuted blocks, stratified by site
- ✓ePRO and participant self-entryPersonal study links, eDiaries, reminders
- ✓eConsentConsent page recorded with version, date and time
- ✓Offline mobile data collectionAndroid app stores entries offline
- ✓Forms in several languagesDemo studies in 11 languages, incl. right-to-left
- ✓CDISC export (ODM / SDTM)ODM 1.3.2, SDTM (XPT, define.xml 2.1)
- ✓Built-in reports and dashboardsCompletion and enrolment dashboards
- ✓Built-in statistical analysist-tests to Cox and mixed models
- ✓Numbered tables, figures and listingsNumbered TFLs, Word/RTF/CSV/PDF export
- ◐APIOn request
- –Free or open-source optionDemo studies and videos are free to view
Verdict
Strengths and limitations
Strengths
- The vendor builds and tests the database for you
- Numbered TFLs and statistical analyses inside the EDC
- CDISC ODM and SDTM export, ePRO, eConsent and an offline Android app
Limitations
- No published pricing or hosting location
- No medical coding (MedDRA, WHODrug) or ADaM datasets
- No link to hospital electronic health records
Details
Pricing, hosting and regulation
Pricing
Quote per study (build, hosting and support); no minimum study size. Published prices: not published. Pricing source.
Hosting and security
Hosting regions: not stated publicly. Ask the vendor where your study data will be hosted.
Certifications: None stated by the vendor.
Regulatory support
Vendor states it is designed to support FDA 21 CFR Part 11, GCP and GDPR. Whatever the software offers, your own procedures, validation and training are still needed for a regulated study.
Scale and set-up
Small to mid-sized studies: academic, investigator-initiated, observational, registries, post-market and ePRO studies. Vendor-built; vendor states straightforward studies can be ready within days.
Alternatives
Alternatives to ResearchGuru EDC
OpenClinica
Small to mid studies wanting published prices or open-source software.
Score 7.7/10 · Unique feature: Open-source Community Edition
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
REDCap
Academic studies at institutions that already run REDCap.
Score 7.1/10 · Unique feature: Free licence through a global non-profit consortium