· Regulatory Negotiations/Submissions · Clinical Research · Corporate Compliance 
· CRO Selection and Management · Budgeting and Forecasting
· Requirements Analysis  · Legal Analysis · Moral Hazards in International Business
· Grant, RFP/Proposal Writing · Coaching/Training · Strategic Planning
· Process/Quality Improvements · Risk Analysis/Management 
· Client/Investor Relations · Gap Analysis · IT Healthcare Technology 
· Team Leadership/Development · Consensus-Building · Fiscal Discipline
· Contract Review and Negotiation · Human Resource Programs 
​· EHR-to-EDC Interoperability · Rescue Trials · IND Regulatory Agent


  • US transfer pricing regulations and at arms' length agreements
  • Navigation of US FDA regulatory landscape: strategy, face-to-face negotiations, pre-Subs, IND, IDE, 510(k), DeNovo submissions, US Regulatory Agent
  • Submittals and regulatory strategist for international regulatory authorities: EMA, UK MHRA/NICE, Australian TGA, Health Canada HPFB, German BfArM, French Ministry of Health, Korean MFDS, and Notified Bodies
  • 20+ years of international clinical research operations, trial design and execution, quality assurance, inspection-readiness, and CRO due diligence/selection/management
  • 18 years of corporate compliance in life sciences and federally-funded programs (NIH, DoD)
  • 16 years of publications/medical advisory/endpoints committee/data safety/adjudication committee management, business development, client relationships, and board interactions
  • 10 years of strategic planning, risk management, and change management 
  • 10 years of process and continuous quality improvement implementation and training
  • 8 years of influence and human resource management in positive corporate culture that prioritizes employee engagement, development and advancement
  • Fiscal discipline and pragmatic forecasting that reduces the squandering of resources or unexpected spend 
  • A lifetime of true grit, creativity, innovation, collaboration, accountability, flexibility, and win/lose early mindset

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Clinical Research Strategies distills the complexities of research and regulatory disciplines into accessible terms and fill gaps in knowledge for life science executives, entrepreneurs, and investors alike, who play a pivotal role in the development and investment of a new product, to improve its chances of clearing performance hurdles toward successful commercialization or exit.