Greenlight Guru Clinical Description
Greenlight Guru Clinical is the only electronic data capture (EDC) system built specifically for medical device and diagnostics companies. While most EDC platforms were designed for pharmaceutical trials and later adapted for medtech, Greenlight Guru Clinical starts from device and diagnostic requirements: FDA regulations, EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and ISO 14155 for clinical investigations.
Designed exclusively for medtech, it combines an easy to use clinical data platform with industry leading customer service, helping teams generate reliable, compliant clinical data with confidence.
Get a single, validated platform with everything needed to run a medical device or diagnostics study, including:
Electronic Data Collection and eCRF, built with pre validated question types that can be cloned and reused across studies
ePRO/eCOA, electronic patient and clinician reported outcomes collected in person or remotely
eConsent
Randomization (RTSM)
PMCF Surveys, purpose built for post market clinical follow up under EU MDR
Adverse Events Reporting
Leading edge, open API for connecting study data to other clinical or quality systems
Greenlight Guru Clinical is used by medical device and diagnostics manufacturers running pre-market clinical investigations and post-market surveillance studies, and by contract research organizations (CROs) that specialize in medtech. Every customer gets a dedicated customer success manager with real medtech experience and a validation package included with every product update. For teams that also use Greenlight Guru's quality management system (QMS), Clinical connects directly into one platform covering quality, product development, and clinical evidence.
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Company Details
Product Details
Greenlight Guru Clinical Features and Options
Electronic Data Capture Software
Clinical Trial Management Software
Greenlight Guru Clinical User Reviews
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Likelihood to Recommend to Others1 2 3 4 5 6 7 8 9 10
Easy to program EDC Date: Aug 31 2026
Summary: Although it is not the most comprehensive data capture I have used, it is a solid entry level option for organizations that need to implement a study but do not have dedicated EDC programming personnel. Can be limited at times but gets the job done while supporting changes during study conduct without causing major issues to data exports for minor changes.
Positive: Can be easily programmed by someone without experience coding or with software. Simple to implement rules and validations. Intuitive to use for sites and study staff. Non-blocking amendments is a great addition in the last year.
Negative: Can be a bit restrictive, for example cannot use calculated values in a validation rule which makes it more difficult to implement controls for inclusion and exclusion criteria. Export labels can be difficult to work with. Skipped or missing visits can cause issues. SDV is difficult to verify only part of a visit.
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Likelihood to Recommend to Others1 2 3 4 5 6 7 8 9 10
Greenlight Guru Date: Aug 27 2026
Summary: Very happy with overall experience. Would recommend the use of Greenlight Guru to other studies as their database.
Positive: It is easy to navigate and use. Everything is clearly labelled. Always support from the data team. Queries are clearly labelled and simple to answer.
Negative: Having to double answer why you are changing an answer. Can be time consuming.
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