The COVID-19 pandemic has demonstrated the feasibility of adapting clinical trials from site-based endeavors to fully decentralized or hybrid models and has increased global acceptance of decentralized trials as a safe and effective option for accelerating clinical research. Enabled by digital, technological, and logistical innovations, decentralized clinical trials offer advantages to both patients and sponsors that will endure beyond the pandemic. In addition to the development of a well-conceived operating model, successful implementation of partially or fully decentralized clinical trials (DCTs) requires a cohesive, coordinated regulatory strategy.
This webinar will review the regulatory and geographic factors that can influence the adoption of DCTs, and provide a roadmap for implementing these trials within the current legal environment in Europe. It will address the critical importance of:
- Advantages of DCTs for patients and sponsors, as well as increased operational (and thus research cost) efficiency
- The nuances of the evolving EU regulatory landscape and how to ensure compliance with differing good clinical practice (GCP) requirements and relevant legislation at national levels
- The importance of a robust and secure technology architecture for trial related data acquisition, storage, and communication
- How to implement a drug distribution and management strategy that meets all stability, storage, and dosing access and administration requirements
Aruna Talapatra focuses on securing market and customer insights on decentralized trials and is working on strategic development and deployment of Thermo Fisher Scientific’s digital supply chain platform clinical trials. Aruna brings over 12+ years of product management experience in the medical device industry and has worked at companies such as GE Healthcare, Fujifilm and Hill-Rom where she has developed Healthcare ecosystems for Medical devices such as MR, Ultrasound, Diagnostic and Non-Diagnostic Cardiology products and Hospital EMR systems. Aruna holds a Master of Science degree in Computer Science from Emory University, Atlanta, Georgia.
Scott Emery holds the position of Global Director of Total Transportation Management (TTM) at Thermo Fisher Scientific. Scott joined Thermo Fisher Scientific in 2013 and was responsible for their global transportation network including the management of offices located in the United States, United Kingdom, Switzerland & Singapore, prior to moving into his current role. Scott has 21 years of experience in global transportation and logistics. Previous to Thermo Fisher Scientific, Scott held leadership roles in global development, sales and operations at DHL Express & National Air Cargo.