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
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