Is Oversight a Burden or Pivotal to Operational Efficiency?

Register free: http://www.appliedclinicaltrialsonline.com/act_w/oversight

Event Overview:

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

Speakers

Stephen Crow
Associate Director, Clinical Performance, Global Clinical Development Operations
Jazz Pharmaceuticals

Steve had over a 17-year career with GW Pharma, before it was acquired by Jazz Pharmaceuticals in 2021, where he currently resides – he has spent five years as a CRA, five as a Clinical Project Manager, four managing programs of clinical trials, before moving into the people/tools/processes side of maintaining a global Clin Ops team. He is currently responsible for the frameworks, tools and processes relevant to ‘clinical performance’ within the Global Clinical Development Operations department at Jazz, including the current implementation of a Clinical Trials Metrics/KPI Framework.

Keith Dorricott
Director, Dorricott Metrics & Process Improvement Ltd.

Keith has a background in manufacturing from Kodak Ltd. and has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master Black Belt in Lean Sigma quality and process improvement techniques and is an expert in root cause analysis developing a novel approach for clinical trials. He speaks regularly at conferences and in webinars on topics from KPIs for oversight to Risk-Based Quality Management. He provides consultancy services and training on KPI selection and use, Risk-Based Quality Management, and root cause analysis. He runs several work groups for the Avoca Quality Consortium.

Elvin Thalund
Director, Industry Strategy
Oracle Health Sciences

Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.

Register free: http://www.appliedclinicaltrialsonline.com/act_w/oversight