Fast & Flexible Clinical Research Services for Precision Medicine

Your Preferred CRO

Your Trusted Partner in Precision Medicine Clinical Research

GBC combines scientific expertise with proven operational excellence to design tailored solutions, navigate complex challenges, accelerate timelines, and bring innovative in vitro diagnostic (IVD), companion diagnostic (CDx), and medical device products to market with confidence and success.

Driving Success Across Every Phase of Clinical Development

Regulatory Strategy

PMA, 510(k), De Novo, Breakthrough Designation, Pre-IDE / IDE submission, Q-sub, IVDR

Exploratory Studies

Pilot studies, proof of concept, feasibility

Pivotal Studies

Clinical performance, feasibility & pilot, safety & efficacy, bridging, label expansion, post approval

Post-Marketing Studies

Research studies, human factors, registries, prospective and retrospective post- marketing studies

Non-Clinical & Analytical Testing

Preparation of protocols and analytical validation plans

Clinical Investigational Plan

Preparation of clinical investigation protocol and compliance documentation

Regulatory Submission

Market application submissions, query resolution, interactive review, labeling, panel meetings

Organizations that Have Partnered with GBC

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Transform Your Vision Into Results