An In Silico Clinical Trial is the use of individualised computer simulation in the design, development and regulatory evaluation of a medicinal product, medical device, or medical intervention. Currently. Biomedical product development and assessment is almost completely founded on experimental testing throughout all phases of development chain, from in vitro bench testing, to pre-clinical animal models, to human clinical trials that demonstrate safety and efficacy of new medical devices. However, predictive computer simulation has the potential to transform the Biomedical Industry through the development and implentation of In Silico Clinical Trial platforms, which exploit exsiting computer simulation technologies that predict physical, checmical and biological performance of implantatble devices within individual patients. In Silico Clinical Trial platforms have the potential to reduce, refine, and partially replace animal testing and human clinical trials throughout all areas of the sector, significant reducing direct and indirect costs. At this stage, it is crucial that industrial, academic, clinical and regulatory stakeholders engage across Europe to address the technological challenges and advance in silico clinical trials for Biomedical products towards more widespread implementation.

The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 777119

Conceptual architecture of InSilc Cloud platform and the Modules dependencies are depicted in Figure below, whereas the beyond the state of the art activities, which are foreseen to achieve the project objectives are described in detail below.

• InSilc concept and methodology for the animal studies
• InSilc in vitro cell models
• InSilc Mechanical Modelling Module
• InSilc Deployment Module
• InSilc Fluid Dynamics Module
• InSilc modelling of myocardium and estimating post-intervention reperfusion
• InSilc Drug delivery Module
• InSilc Degradation Module
• InSilc “virtual” populations   

InSiSt is a multidisciplinary Consortium with complementary expertise and experience to support the value chain that the project envisages to achieve. Interventional cardiologists, technical partners with extensive expertise in the field of computer modelling and simulation: (i) biomedical imaging (USFD, FORTH), (ii) coronary fluid dynamics (ERASMUSMC, USFD, CBSET), mechanical modelling and biomechanics (POLIMI, FORTH, NUIG, USFD, BIOIRC), experts in the field of in vitro mechanical testing (BIOIRC) and animal studies (CBSET), biology experts (CNR, FORTH), CRO with significant experience in providing services for regulatory authorizations and clinical trials for biomedical products (MCR), Cloud experts for platforms development and integration (FEOPS), Stent Biomedical Industry with high expertise in the design, development and manufacture of coronary stents (BSL) will join forces to accomplish the InSiSt objectives and deliver all the intermediate and final project expected outcomes. The InSiSt Consortium includes 12 partners from 8 different EU countries and one US partner (CBSET).