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We apply the in silico trials standard methodology with the most robust and versatile technology platform in our industry

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in silico Clinical Trials: How Computer Simulation will Transform the Biomedical Industry – Roadmap produced by Avicenna Consortium

Marco Viceconti, James Kennedy, Adriano Henney, Markus Reiterer, Sebastian Polak, Dirk Colaert, Jean-Pierre Boissel, Martina Contin, Claudia Mazzà, Annamaria Carusi, Enrico Dall’Ara, Matthew Burnett, Iwona Zwierzak, Karen El-Arifi, Massimo Cella, Giuseppe Assogna, Robert Hester, Filipe Helder Mota | Avicenna Consortium. 2016 January;DOI: 10.13140/RG.2.1.2756.6164

Abstract

The term ‘in silico clinical trials indicates the use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention. This review article summarises the research and technological roadmap developed by the Avicenna Support Action during an 18 month consensus process that involved 577 international experts from academia, the biomedical industry, the simulation industry, the regulatory world, etc. The roadmap documents early examples of in silico clinical trials, identifies relevant use cases for in silico clinical trial technologies over the entire development and assessment cycle for both pharmaceuticals and medical devices, identifies open challenges and barriers to a wider adoption and puts forward 36 recommendations for all relevant stakeholders to consider.