Greenlight Guru Clinical now supports MedDRA coding for adverse events

Greenlight Guru Clinical now codes adverse events with MedDRA, the Medical Dictionary for Regulatory Activities, directly inside the platform. Clinical data managers work from AI-generated code suggestions and accept, reject, or override each one, without exporting data to a separate tool or waiting on a standalone verification loop.

Until now, that coding has happened outside the electronic data capture (EDC) system where the clinical data lives. A coder looks up the preferred term online, copies it into a separate form, and routes it to a reviewer for verification. That's a manual, time-consuming process that is open to human error and requires users to leave the EDC system they're working in to accomplish the task.

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Coding that lives where your clinical data already does

Pulling the coding into the EDC removes that manual process. Because Greenlight Guru Clinical is purpose-built for medical device studies, the coding record sits inside an audit trail and a data structure already aligned to ISO 14155 and regulatory submission expectations. The medical code is attached to the adverse event report, which lives within the system, ensuring full traceability.

AI suggestions, with a human approving every code

The feature suggests codes, but it never applies them on its own. When an adverse event is entered, Greenlight Guru Clinical proposes a MedDRA code, and a permissioned user accepts it, rejects it, or overrides it with a different term. Nothing is coded automatically, and nothing skips review. Ambiguous diagnoses, multi-code scenarios, and the cases that genuinely need a coder's judgment still get it.

What changes is the starting point. Instead of each person reaching for their own interpretation, the team works from consistent suggestions generated by the same underlying logic, so the same adverse event term is far more likely to be coded the same way twice. That repeatability is exactly what reviewers and auditors look for in a coded dataset.

Who gets the most out of it

Clinical data managers and research coordinators handling day-to-day coding will feel this first, because the tool removes the constant context-switching their work used to require. For contract research organizations (CROs) and device companies running investigations where MedDRA coding is a contractual or regulatory requirement, it removes something larger: a capability gap that used to send teams to a separate tool, or send a deal to a different vendor.

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Keep reading

If you are building out your clinical data coding and adverse event reporting process, these related guides go deeper on the specific components:

• Medical device adverse event reporting regulations: EU vs. US
• Data management and reporting in FDA-regulated clinical trials
• Clinical data management system (CDMS) for medical device clinical trials
• Compliant adverse event reporting in clinical studies under the EU MDR
• Ultimate guide to ISO 14155:2020 for medical devices
• Writing a clinical investigation plan (CIP): the essential guide

See it in your own workflow

Medical Coding of Adverse Events with MedDRA is available in Greenlight Guru Clinical today. Current customers can reach their customer success manager to switch it on or to walk through how it fits the studies they already have running. If you are not yet a Greenlight Guru Clinical customer, get a free demo today to see MedDRA coding alongside the rest of the EDC built for medical device teams.