This webinar is intended to help guide individuals towards a better understanding of core concepts and requirements for using real-world data (RWD). Here, we will delve into how one can derive and utilize real-world evidence (RWE) in drug development, from the perspective of a clinical trial programmer/data analyst. We will discuss the potential opportunities that can generate RWD to improve the safety, efficiency, and quality in a clinical paradigm. The knowledge shared in this presentation echoes the regulatory guidance’s for use of RWE. Evolving standards that are necessary to make the most out of RWD, demonstration projects, and first-hand experience with some technical tools will be discussed. Combining it all together should provide the tools and knowledge to navigate more confidently through this less explored, but complex landscape of RWD and RWE.
- Narasimha Ayyalas, Manager, Statistical Programming, MMS Holdings
- Aditya Gadiko, Senior Clinical Programmer, MMS Holdings
- Susheel Arkala, Manager, Statistical Programming, MMS Holdings
- Chris Hurley, Associate Director, Data Sciences, MMS Holdings
- Ravi Yandamuri, Principal Clinical Programmer, MMS Holdings