2022 | September / October 2022

Real-world evidence in clinical research: challenges and opportunities

by cyb2025

ELEONORA COMI
Medical Manager, Prineos, Italy

INTRODUCTION
Randomized controlled trials (RCTs) are considered the scientific gold standard for demonstrating safety and efficacy of an investigational treatment, as well as obtaining its regulatory approval and authorization for marketing. However, the RCT paradigm is neither perfect nor infallible (1, 2).

ABOUT THE AUTHOR

Eleonora Comi (Medical Manager, PRINEOS srl) holds a PhD in Neuroscience and has gained valuable experience in both the preclinical and clinical research fields working in pharmaceutical and contract research companies. She strongly believes that Medical Affairs is ideally in the position to contribute bridging the gap between patients and the research community and its stakeholder.
PRINEOS srl is a new strategic consulting company born and raised by passion, leveraging on a team with more than 25 years of expertise in the Life Sciences.
Our goal is to improve and innovate Clinical Research in Healthcare providing services on: Biostatistics, Medical Affairs, Regulatory and Legal Affairs.

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