Fast & Flexible Clinical Research Services for Precision Medicine
With a Blend of Scientific, Operational, and Commercial Acumen GBC Designs and Implements Practical Solutions to Turn Expertise and Innovation into Success
Your Trusted CRO Partner to Support Precision Medicine Clinical Research Studies
GBC applies operational excellence to design tailored clinical trial solutions, navigate complex challenges, accelerate timelines, and execute successful studies to bring innovative in vitro diagnostic (IVD), companion diagnostic (CDx), and medical device (MD) products to market with confidence and success.
Driving Success Across Every Phase of Clinical Research & Development
Regulatory Strategy
US & EU Regulatory Strategy, Intelligence, Interactive Prep, Marketing, Labeling, Quality Management
Exploratory Studies
Feasibility Studies, Proof of Concept Studies, Pilot Studies
Pivotal Studies
Clinical Performance, Safety & Efficacy, Bridging Studies, Label Expansion Studies
Post-Marketing Studies
Follow On Research Studies, Human Factors Studies, Registries, Post- Marketing Studies
Non-Clinical & Analytical Testing
Preparation of Investigational Plans and Study Protocols, Analytical Validation Protocols
Clinical Investigational Plan
Preparation of Clinical Investigation Plans and Clinical Validation Protocols, Bioethical and Good Clinical Practice (GCP ) Compliance
Regulatory Submission
PMA, 510(k), De Novo, Breakthrough Device Designation (BDD), De Novo, Pre-IDE, IDE, Q-Sub, Study Risk Determination (SRD), Performance Evaluation Applications (PEA), Query Resolution, Interactive Review, Panel Meetings
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