Clinical Research Consulting

Clinical Research Consulting

Chief Medical Officer Services

The CMO plays a critical role in both emerging and large pharma / biotech.  The  role can vary from largely clinically focused in the earlier stage companies to the more policy and Medical Affairs oriented role in larger corporations.  Fiore Healthcare Advisors staff have experience as CMO and are keenly aware of what keeps the CMO "up at night".  Leveraging our staff backgrounds we offer the following services.

  • Serve as interim CMO during periods of transition or for "virtual" companies requiring this
  • Design clinical programs and implement medical oversight aligned with ICH E6 and FDA Risk Based Monitoring
  • Design CMO performance 'dashboard' to visualize and track elements from CMO areas of responsibility
  • Establish global and local medical governance structures for large pharmaceutical companies
  • Perform medical due diligence at the product or enterprise level
Medical and Safety Monitoring of Clinical Trials and Programs

Fiore Healthcare Advisors has a proprietary 5-step approach toward ensuring robust and comprehensive medical oversight of clinical trials activity, as follows:

  • Understand program and establish monitoring goals
  • Design approach, timing and documentation strategy
  • Determine data needs and design data outputs
  • Analyze data, draw conclusions, formulate recommendations
  • Document, communicate and refine approach as needed
Safety Review Committees and Advisory Boards

Fiore Healthcare Advisors has significant experience with clinical trials and safety governance activities.  Governance activities can include supporting dose escalation decisions in early stage trials, performing overall safety reviews of clinical and / or postmarketing data, and any other situation where a governance approach is required.  We offer the following services for Safety Review Committees and Advisory Boards:

  • Governance committee charter authoring and development
  • Direct membership, including leadership, of safety and clinical governance bodies
  • Bringing any of our large advisor network onto a safety governance body