Core Services

●       Short and long-term leadership, project-based consulting, and strategic planning

●       Protocol, feasibility and regulatory advice, ensuring patient and site centered trial design

●       Acceleration of portfolio and program delivery, identifying bottlenecks and implementing corrective action plans

●       Supervision of Clinical Research Organizations (CROs) and vendors, leveraging extensive sponsor and CRO collaboration expertise

●       Implementation of risk-based monitoring (RBQM) and quality by design

●       Development of site and patient engagement strategies, including recruitment, retention, and diversity initiatives

●       Design and execution of decentralized and hybrid trial models, including operational design, vendor integration, and execution support

Key Differentiators

●       Executive leadership, project management and regulatory expertise of Phase I-IV global trials with budgets exceeding $200M 

●       Track record leading and managing project teams across functional groups of 25+

●       Published and recognized leader with collaborations across academia, CROs, pharma, and government sponsors

●       Experience directing large programs with industry, government and cooperative group sponsors

●       Extensive expertise in oncology, pediatrics, infectious disease, and rare diseases

●       Track record in decentralized and hybrid trial execution with technology and vendor integration

●       Proven success implementing AI-driven operational tools for compliance and resource management

●       Licensed RN with 27 years’ experience across academia, CRO, and site operations

Select Publications

• Ethical Challenges in Genotype Driven Recruitment

• Ipilimumab and Radiation in Patients with High-Risk Melanoma

• Say Yes! COVID Test