At Go-To-Market-Diagnostics, we understand that diagnostics and biomarker companies need to navigate a complex web of challenges to successfully launch their products in the U.S. markets. That's why we offer comprehensive services that analyze strategy, clinical operations, regulation, and reimbursement - all in one place. By taking care of these critical components, we allow our clients to focus on what they do best: science and product development.
Our team is made up of industry leaders with deep knowledge and expertise in diagnostics and biomarkers. And the best part? We offer our services at a cost-effective price, making our service accessible to companies of all sizes. Let Go-To-Market-Diagnostics be your trusted partner in commercializing your products in the U.S. markets.
Traditionally, regulatory and reimbursement consultants operate separately, which results in fragmented execution. Additionally, clinical operations are often conducted with minimal consideration for the future commercialization process. At GTMDX, we recognize this issue and aim to provide a comprehensive solution.
We offer access to a network of industry veterans, who can provide valuable insight and expertise. Our comprehensive go-to-market analysis and clear strategy and operation guidelines cover all the steps necessary for successful commercialization in the U.S. clinical diagnostics market. By taking a holistic approach that encompasses regulatory, reimbursement, and clinical considerations, we help our clients achieve their goals more efficiently and effectively.
o FDA-cleared/approved In-vitro diagnostics (IVD) kits
o CLIA & Lab Developed Tests (LDT)
o Analytes Specific Reagents (ASR)
o Regional/centralized clinical labs
o Hospital labs
o Physician Office Labs (POL)
o Point of Care (POC)
o Direct to consumers (DTC; Direct Access OTC)
o Pharma/Biotech clinical development (direct/CRO)
o Payers as clients (pmpm; actuary analysis)
o Medical Necessity
o Benefits and health outcome
o Health economics
o Site IRB
o Multisite IRB
o Company Central IRB
o Ensure GTM requirements
o Adding multi-modal data
o PTS and RWD review
o Network of biobanks
o Prospective collections
o Specimens management & storage
o Network of third-party labs for method validations
o "Research ready" sites
o Study design
o Data analysis
o Regulation submission
o 510(k) clearance
o De-novo classification
o Pre-Market Approval (PMA)
o CLIA requirements
o Preparation
o Mock inspection
o Discuss your test with LBMs
o LBM medical policy
o Have payers' medical directors' advisory meeting
o Understand the Payers Blueprint
o Clinical utility
o Health economics
o Real-life evidence
What we do, and how we do it is to ensure your success.
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