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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