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A Regulatory Landscape Shift for In Silico Clinical Trials

Post thumbnail A Regulatory Landscape Shift for In Silico Clinical Trials

Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to safety, efficacy, dosing, and special target populations. As both computing power and our understanding of human systems biology improve, the increased use of M&S motivates regulators to consider this new type of digital evidence to support medical device and medicinal drug product development and allow new approaches in clinical trials, in view of increasing the probability of success, reduce costs and accelerate time to patients.

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    publication by

    Cécile Rousseau
    Cécile F. Rousseau, PhD
    Director, Nonclinical
    With 10+ years in nonclinical and translational research and histotechnology, Dr. Cécile F. Rousseau has considerable expertise in medical devices,…
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    Emmanuelle M. Voisin, PhD
    Emmanuelle M. Voisin, PhD
    Founder and CEO
    Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. The firm has become a leading advisor to Biotech,…
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    Susan Carter thumbnail
    Susan Carter
    M.Sc., Director, Regulatory Science
    As a Director, Regulatory Science, Susan provides scientific and regulatory advice to clients for the development of small molecules and biologics particularly with regards to rare diseases. The projects she manages are in various stages of development, from nonclinical through to marketing application.
    Cécile Crozatier thumbnail
    Cécile Crozatier
    Operations Director
    David A duVerle thumbnail
    David A duVerle
    Chief Scientific Officer at Novadiscovery
    Marc Buyse thumbnail
    Marc Buyse
    Chief Scientific Officer at IDDI and CluePoints
    François-Henri Boissel thumbnail
    François-Henri Boissel
    CEO Novadiscovery