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