Greenlight Guru QMS & EDC Partner — bioaccess®
bioaccess® is an official Greenlight Guru partner. Greenlight Guru provides a MedTech-specific Quality Management System (QMS) and Clinical Electronic Data Capture (EDC) platform, integrated into bioaccess®'s first-in-human and early-feasibility clinical trials across Latin America.
What the partnership means for sponsors
- Integrated quality management and clinical data workflows that consolidate quality and clinical data workflows, reducing reliance on disconnected systems.
- Purpose-built MedTech QMS aligned with ISO 13485 and design-control expectations, rather than a general-purpose document system.
- Clinical EDC that keeps first-in-human study data — English-language, monitored data package built under ISO 14155 GCP to support eligibility for FDA acceptance under 21 CFR 812.28 (acceptance is FDA's decision, per submission).
How it fits your FIH program
When bioaccess® runs your first-in-human study, quality records and clinical data can be captured in Greenlight Guru from protocol through clinical study report — giving sponsors a consolidated, inspection-supportive record set that carries forward into regulatory submissions and diligence.
Related: Clinical trial services · First-in-Human CRO
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