Webinar | July 20, 2022

Is Oversight A Burden Or Pivotal To Operational Efficiency?

Source: Oracle Health Sciences

As the complexity of clinical trials continues to increase, the importance of CROs to the pharmaceutical industry has increased significantly. Outsourcing allows pharmaceutical companies to utilize on-demand services, improving operational efficiencies by accessing therapeutic expertise and geographic reach. This reflects a sharper focus on core competencies and a shift to allow CROs to manage and conduct clinical trials.

The use of KPIs for ongoing risk management from ICH E6 (R2) creates both opportunities and challenges in the sponsor-CRO collaboration.

However, the forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines focus on Quality by Design (QbD) to gain efficiencies in conducting clinical trials – significantly impacting oversight.

Key Learning Objectives:

  • Selection, implementation, and use of KPIs in a sponsor-CRO collaboration.
  • Challenges associated with metric definitions – what if the CRO’s system doesn’t capture the data? Or if their process is different?
  • Importance of context in interpreting KPIs.
  • The often, over-looked human aspect – the benefits of addressing mindset and culture change.
  • Tools provided by ICH E6 and E8 guidance’s to drive efficiencies in clinical trials.
  • How organizations can improve their operational efficiencies by adopting automation, standardization, and eliminating unnecessary duplicate processes/technology.

Who Should Attend:

  • Sponsor and CRO roles who are responsible for:
    • Vendor oversight
    • Clinical data management, collecting and evaluating trial metrics
    • Project management of studies and operational excellence

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