Greenlight Guru Clinical - 2026 Pricing, Features, Reviews & Alternatives

Most electronic data capture (EDC) systems were built for pharmaceutical trials, then stretched to cover medical device and diagnostics studies. Greenlight Guru Clinical takes the opposite approach. It is the only EDC platform built from the ground up for medtech, aligned to FDA regulations, EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and ISO 14155 for clinical investigations, so device and diagnostics teams are not reconfiguring a pharma workflow to fit their study.

Designed exclusively for medtech, Greenlight Guru Clinical combines an easy to use clinical data platform with industry leading customer service, so teams generate reliable, compliant clinical data with confidence at every stage, from first-in-human and feasibility studies through pivotal trials and post-market clinical follow up (PMCF).

Get a single, validated platform with everything a device or diagnostics team needs to run a study, including:

Electronic Data Collection and eCRF design: build electronic case report forms with pre validated question types, then clone and reuse them across studies to reduce setup time on every new protocol

ePRO/eCOA: electronic patient reported outcomes and clinician reported outcomes, collected in person or remotely on any device, so outcome data comes in structured and submission ready

eConsent: electronic informed consent that keeps enrollment compliant and auditable from the first subject forward

Randomization (RTSM): randomization and trial supply management for controlled and comparative device studies

PMCF Surveys: purpose built tools for the post market clinical follow up EU MDR requires after a device reaches market, so ongoing evidence generation does not require a separate system

Adverse Events Reporting: structured adverse event and serious adverse event tracking built into the same platform as the rest of the study, not a bolted on module

Leading-edge, open API: a two way API so study data can move securely between Greenlight Guru Clinical and other clinical, quality, or regulatory systems

Data ownership is built in, not sold as an upgrade. Study teams can export, analyze, and reuse their own data without additional fees or routing through a CRO's system to access their own study. For manufacturers who work with CROs, Greenlight Guru Clinical still gives the sponsor visibility and control over the data rather than depending entirely on the CRO's tools and timelines.

Greenlight Guru Clinical supports pre-market clinical investigations, post-market surveillance studies, registries, and human factors testing, and is used by both device and diagnostics manufacturers and by contract research organizations (CROs) that specialize in medtech and need a platform that fits their sponsors' regulatory context without a custom build for every new study.

Most teams are up and running in 14 days, with no lengthy implementation project or months-long configuration cycle before a study can start collecting data.

Every customer gets a dedicated customer success manager with real medtech experience, not a generalist account rep, along with a validation package included with every product update so the quality team is not stuck revalidating the platform each time it changes. Support also includes the Greenlight Guru online support team, a knowledge base, and an on-demand training academy, all included in the subscription.

For manufacturers already using Greenlight Guru's quality management system (QMS), Clinical connects directly into one platform spanning quality, product development, and clinical evidence, so clinical data does not sit disconnected from the rest of the quality system. For teams that do not use Greenlight Guru QMS, Clinical also works as a fully standalone EDC solution.

If your team is spending more time configuring pharma-built EDC software around ISO 14155 and MDR requirements than actually running your study, Greenlight Guru Clinical was built to solve exactly that problem.