Clinical Strategy

In order for a new investigational product to enhance patient’s lives and become an effective component of our healthcare system, the clinical development process and subsequent propagation into the market must be strategic, focused and unified.

Effective clinical program development includes:

  • An assessment and understanding of your needs and the specific market place
  • An understanding of the therapeutic indication and the challenges of disease or condition management
  • Strategic regulatory planning with the Sponsor and interaction with regulatory bodies
  • Development of effective clinical protocol with an emphasis on appropriate endpoint selection, eligibility criteria, and data collection guidelines
  • Conduct of comprehensive country and protocol feasibility assessment
  • Effective Case Report Forms (CRF) to capture important study information
  • Analysis of study endpoints
  • A mechanism to capture specific adverse events, then adjudicate and summarize those safety events
  • Experienced development of study related documents including: monitoring plan, ICF, DMC and CEC charters, study reports and final study reports

BBA’s clinical trial design team members are experienced clinical researchers with a breadth of knowledge in many therapeutic areas.  Our team can partner with you to develop your clinical program, ensuring that the clinical trial process is streamlined to demonstrate product safety and effectiveness and of the highest quality to meet regulatory scrutiny.

Partner with us and we will develop strategies that exceed expectations.

To Discuss Development of Your Clinical Strategy

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