Specialties:

· 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

ABOUT

  • 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

© Copyright 2018 Clinical Research Strategies. All Rights Reserved.

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.