It is a today common opinion that the vast potential of Real-World Data (RWD) is a valuable resource not only for disease understanding but also for product development, health technology assessment and market access.
In this context is very much important to understand the pivotal role of research methods in collecting Real World Evidence (RWE) to support regulatory decisions and /or to allow a strategic use of clinical RWD.
This 2-step intensive course will allow you to learn how to setup a methodologically sound RWD collection able to generate RWE, focusing on several critical success factors: methodological, regulatory and operational.
Gain insights into navigating the digital health era, understanding regulations that impact real-world research, and effectively organising and conducting data collections.
Step 1 of this course empowers you with essential knowledge, covering topics like methodological and technical aspects of real-world studies, different study designs and applications and how to manage the complexity of a very heterogenous regulatory environment.
Step 2 explores the concept of "study-project dualism" in real-world research, where study and project objectives may not align entirely. Grasp the strategic design phase's importance in overcoming organizational and cultural barriers, involving various stakeholders from clinical R&D, marketing, market access, and more.
A remote homework, between step 1 and 2, will allow you to consolidate the notions and concepts learned by applying them to a real case taken from your company context, which you can then use to deepen the advanced design techniques that will be exposed in the second part of the course, learning from a well-established methodology, honed through the successful design of numerous observational studies, how to align study and project objectives seamlessly.