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Megan Lamberti

Vice President of Clinical and Regulatory Affairs

Nilo Medical Consulting Group

Megan Lamberti MTM, CRA is currently the Vice President of Clinical and Regulatory Affairs at Nilo Medical Consulting Group. Megan has previously worked as an independent consultant advising on clinical trial design and operations, as a clinical research associate (CRA), monitor and project director on the CRO side of research, in industry managing clinical affairs on behalf of her clients, and in academia as a clinical research coordinator. Megan has worked on several trials in sensitive populations including maternal/fetal dyads in utero, rare pediatric disorders, and other orphan populations. Working on clinical trials in highly debilitating and/or rare conditions carries unique regulatory challenges and unpredictable ethical considerations. Megan’s experience navigating the FDA, IRBs, Sponsors, Investigators, study team members and study participants and their families in rare disease and orphan populations has engendered her insight into the importance of invoking empathy in the conduct of clinical research.

Session

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