Is Oversight A Burden Or Pivotal To Operational Efficiency?

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