The Evolving Role of CTMS in Risk Management

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Clinical trials are a necessary and critical activity in releasing new, and often-times lifesaving, drugs and medical devices to the market. To achieve success, however, life sciences organizations are under severe pressure to manage these trials in a way that is risk-averse in the face of rising development costs, and fewer approvals.

During this webinar, Sondra Pepe, Senior Director, Clinical, discusses the evolving role of a clinical trial management system (CTMS), and its role in managing risk. Sondra discusses how a CTMS that is comprehensive, designed for multiple stakeholders, and is easy to manage can help stakeholders address the unique milestones, risks, and key performance indicators inherent in a typical clinical trial. The webinar covers:

  • Industry challenges inherent in clinical trial management
  • The ICH E6(R2) regulatory response
  • Risk management process and risk-based monitoring effectiveness
  • Effective site feasibility assessment practices
  • Milestone, KRI and KPI planning and management