Reserve Your Strategy Session
We excute clinical programs across three phases
Phase 1: Assessment
Comprehensive evaluation of your clinical and regulatory approach.
Scope:
Technology assessment and clinical claims validation
Regulatory pathway determination (510(k), De Novo, PMA)
Protocol feasibility analysis
CRO landscape evaluation
Risk identification and mitigation strategy
Budget and timeline development
Go/no-go recommendation with rationale
Phase 2: Clinical Execution
End-to-end clinical program management from protocol development through data lock.
Scope:
CRO selection, contracting, and ongoing management
Protocol development and IRB submission strategy
Site identification, qualification, and activation
Enrollment monitoring and performance optimization
Data collection oversight and quality assurance
Regulatory correspondence and strategy
Weekly executive reporting and board presentation support
Real-time issue resolution and protocol amendments
Phase 3: FDA Clearance
FDA submission preparation and clearance pathway management.
Scope:
510(k) or De Novo submission preparation
Clinical data analysis and reporting
FDA Pre-Sub meeting strategy (when applicable)
Submission quality review and filing
FDA question response and deficiency management
Additional testing coordination (if required)
Clearance timeline management and investor communication
