SERVICES
STRATEGIC DEVELOPMENT
- Clinical development and protocol planning for device, human factors, diagnostic and therapeutic indications
- Product development and lifecycle planning including key milestones, resource and hiring requirements and deliverables
- Clinical, regulatory, business and reimbursement case-building for study design across all phases of development
MEDICAL/CLINICAL AFFAIRS
- Key opinion leader relationship-building
- Customer-defined unmet clinical need, comparator or gold standard and target patient population
- Professional society meeting and publication planning
CLINICAL OPERATIONS
- Study design and development of associated critical documents and SOPs
- All phases of development: verification and validation, clinical utility, health economics and patient outcomes
- Biosample and data management
- Clinical operations team-building and leadership
- Vendor oversight
SPEAKING/WRITING
- Strategic positioning of novel diagnostic tests
- Clinical development
- Study design
- Regulatory strategy for laboratory-developed tests and in vitro diagnostics
CLINICAL TRIAL MATCHING AND SITE SEARCH
- Clinical trial search and expertise for individuals seeking novel treatment options
- Site selection for sponsors seeking rapid onboarding and enrollment success
CLIENT WORK
My client work takes companies from bench to launch, and my scope spans from daily operations to CEO and board engagement. Projects range from three months to several years in length, are customized to client needs, and include clearly defined milestones and deliverables.
