Clinical Case Management Software

GCP Compliant Ad-Hoc Data Collection

The ideal clinician-friendly, GCP compliant, mobile-first data collection tool for high-quality data in post-market settings.

1,000+ of the world's leading MedTech companies trust Greenlight Guru.

Superior Ad-Hoc Data Capture

Collecting GCP compliant ad-hoc data has been a tough nut to crack for many medical device manufacturers – Greenlight Guru Clinical's Cases module is here to fix that. Empower clinical staff to easily deliver data either during or after application of a medical device in practice, and ensure fresh-in-mind data while minimizing their burden.

Simple and Compliant Prospective Data Collection

Greenlight Guru Clinical Cases is specifically designed to enable device manufacturers to collect high quality and compliant ad-hoc prospective data in post-market settings.

Patient-Specific Data Collection

A unique feature of Greenlight Guru Clinical Cases is the ability to easily collect data specific to individual patients.

Identify Safety Concerns in Real Time

Track survey responses in real-time to monitor response rates, analyze data, and quickly identify or get notified with potential safety concerns with your device.

Ensure Traceability

All data inputs automatically include automatic user identification to ensure full traceability of where all data came from and who entered it.

Simplify Clinical Data Compliance

The existing quality management processes at Greenlight Guru Clinical simplify compliance with ISO 14155:2020, FDA CFR 21 Part 11 and EU GDPR by taking care of system validation and specification requirements

Simplified Post-Market Ad-Hoc Data Collection

Collect clinical outcomes, safety & vigilance, clinical experience, and usability data with ease.

Fast and intuitive 3-step study builder. 90 seconds is all it takes!

Adapt forms according to different devices or product families and keep track of all post-market data on products within the same family – all in one place. No need to create projects or studies for each device.

Distribute each study however you prefer, you can even print a QR-code directly on your device packaging.

Enjoy automatic SMS validation of subject identity to ensure full data traceability.

See More of Our Cases Software

Get a deep dive into our Cases software and see how it can take your outcome data collection to the next level.

500 +

MedTech Clinical Trials

Study Setup in 2-3

Weeks

Support for 40 +

Languages

Frequently Asked Questions

What types of data can I collect with Greenlight Guru Clinical?

Greenlight Guru Clinical enables collection of a wide range of patient-specific data, including outcomes, usability feedback, clinical experience, safety and vigilance events, and post-market survey or registry data. The Cases module is designed for ad-hoc, prospective data capture in post-market settings.

How quickly can I set up and launch a new study?

Studies can be built in minutes with Greenlight Guru Clinical’s intuitive 3-step builder. The Cases module allows teams to launch studies in as little as 90 seconds, eliminating delays and accelerating data collection.

Can this software be used for both pre-market and post-market studies?

Yes. While the Cases module focuses on post-market data, Greenlight Guru Clinical supports both pre-market and post-market evidence needs, including registries, pivotal trials, PMA studies, and PMCF surveys.

Can I reuse forms and templates across multiple studies or product families?

Yes. Teams can adapt and reuse existing forms and templates across multiple studies or device families, ensuring consistency and reducing the need to start from scratch for each project.

How does Greenlight Guru Clinical ensure data security?

Greenlight Guru Clinical is built with robust security and compliance controls, including GDPR-compliant hosting in Microsoft Azure, role-based access, audit trails, and Part 11-compliant electronic signatures. The platform is aligned with ISO 14155:2020, FDA 21 CFR Part 11, and GCP standards to keep data secure and inspection-ready.

How is the Cases module different from traditional EDC or CTMS tools?

Unlike traditional EDC or CTMS tools which often require rigid study structures and lengthy setup, the Greenlight Guru Clinical Cases module is optimized for flexible, ad hoc data collection in post-market environments. It supports decentralized workflows, rapid setup, and subject-specific form delivery, making it ideal for PMCF, registry, or complaint-related studies where pre-scheduled visits aren't feasible.

Can I use the Cases module without a predefined visit schedule?

Yes. The Cases module is designed for use cases that do not require fixed visits. Forms can be filled out independently by investigators, sites, or subjects whether for a one-time event like a complaint or recurring follow-ups in a registry.

Who typically uses the Cases module in a study?

The Cases module supports diverse user roles including sponsors, monitors, investigators, and even subjects via ePRO or eConsent. Study owners can control access with role-based permissions and ensure that each stakeholder sees only what is relevant to them.

Is the Cases module compliant with regulatory standards?

Yes. Greenlight Guru Clinical including the Cases module is validated and aligned with ISO 14155:2020, FDA 21 CFR Part 11, ICH-GCP, GDPR, and HIPAA. The system features electronic signatures, audit trails, and full traceability to support inspection readiness.

Can I link forms to specific subjects, devices, or events?

Absolutely. Each case in the module can be tied to individual subject IDs, device details, event types (such as adverse events or complaints), and more, providing structured, filterable insights across your dataset.

How does monitoring and query management work in the Cases module?

Monitors can review data using a dedicated read-only interface, raise queries, and lock form answers once verified. The built-in audit log captures all activity to ensure transparency and compliance.

QMSR is coming. Is your quality system ready?