Clinical Research

Fiore Healthcare Advisors have deep experience in Clinical Research.  We develop Clinical Research strategies and execute high quality programs to generate data that meet overall scientific needs.

The CMO plays a critical role in both pharmaceutical and biotechnology companies.  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. Our former CMO’s are keenly aware of what keeps the CMO “up at night”. We leverage our experience to 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
  • Perform medical due diligence at the product or enterprise level

We have 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

Our team 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
  • Appointing an advisor from our extensive network onto a safety governance body