InSilicoTrials
InSilicoTrials operates a cloud-based in silico clinical trial simulation platform combining 500+ validated mechanistic and AI models across nine therapeutic areas, serving pharmaceutical, biotech, medical device, and regulatory clients to de-risk drug development and accelerate submissions.
- Company typePrivate
- Founded2016
- HeadquartersTrieste, Italy
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What InSilicoTrials does
InSilicoTrials is an Italy-based computational modeling and simulation company that operates a cloud platform for running in silico clinical trials, founded in 2016 and headquartered in Vigevano with an additional presence at Belgium's Health Campus Limburg. The platform combines mechanistic models — including quantitative systems pharmacology (QSP), physiologically-based pharmacokinetic (PBPK), and pharmacokinetic/pharmacodynamic (PKPD) frameworks — with AI-augmented simulation and digital-twin-style patient modeling to help pharmaceutical, biotech, and medical device sponsors de-risk development decisions, optimize trial design, and generate regulatory-acceptable evidence without running full live studies.
The product portfolio spans four primary surfaces. The Scientific Platform houses 500+ validated modeling frameworks across nine therapeutic areas; the Operations Platform handles execution, integration, and workflow management; IRIS is a multi-agent AI orchestration layer that connects models, datasets, and decisions; and MOL2CLIN, launched in partnership with Microsoft Discovery, applies generative AI to move from molecular design through patient-level simulation. The platform is backed by 500M+ patient data points and 50+ peer-reviewed publications, and the company has co-developed "Toward Good Simulation Practice" guidance with the FDA, with the FDA itself having purchased a license to the XPS module. Logo partners include Genentech, Merck, Pfizer, Takeda, Johnson & Johnson, and Sanofi.
Revenue is generated through an enterprise SaaS model with quote-based, multi-year contracts, supplemented by strategic consulting and channel partnerships — notably with Premier Research as a CRO reseller and AVL Partners for distribution. Customer concentration is moderated by both a diversified pharma/biotech/medical device/regulator customer mix and the fact that logo partners may represent pilots rather than full enterprise agreements. Recent strategic activity includes an ARPA-H CARDIOVERSE award of up to $30M (December 2025), Microsoft Discovery integration and MOL2CLIN launch (February 2026), entry into the Microsoft for Startups Pegasus Program (June 2025), and the launch of an AI-Driven Safety Assessment Suite (May 2025).
InSilicoTrials firmographics
Firmographics- Name
- InSilicoTrials
- Legal name
- InSilicoTrials Technologies Ltd
- Website
- https://insilicotrials.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- InSilicoTrials operates a cloud-based in silico clinical trial simulation platform combining 500+ validated mechanistic and AI models across nine therapeutic areas, serving pharmaceutical, biotech, medical device, and regulatory clients to de-risk drug development and accelerate submissions.
- Ownership category
- akta.pro rank
InSilicoTrials industry classification
Industry- Product category
- Pharmaceutical R&D Simulation Software
- NAICS
- Computer Systems Design and Related Services (54151), Computer Systems Design Services (541512), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Computer Integrated Systems Design (7373)
- akta.pro primary industry
- In Silico / Computational Toxicology & PK/PD Modeling (HLAGAFAM)
- akta.pro secondary industries
- AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO), Clinical Pharmacology & Pharmacometrics (Modeling & Simulation) (HLAIALAG)
Keywords
Where InSilicoTrials is headquartered
LocationHeadquarters
- HQ city
- Trieste
- HQ country
- Italy
- HQ region
- Europe
Offices4 records
Markets served
InSilicoTrials business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel
Revenue model
- Software Platform Subscription / SaaS: Enterprise cloud platform access providing computational modeling, simulation, and AI tools for drug development. Accessed via subscription model aligned with FDA and EMA guidelines. Platform includes scientific simulation tools, operations forecasting, IRIS AI orchestration, model libraries, and data libraries.
- Strategic Research & Development Partnerships: Collaborative projects with pharmaceutical and biotech partners to apply InSilicoTrials' computational modeling to specific drug development programs — e.g., Axoltis Pharma (ALS/neurodegenerative), Telomir Pharmaceuticals, Biofarma Group. Typically structured as fee-for-service or milestone-based engagements.
- Regulatory & Compliance Consulting Services: AI Compliance Readiness Program — training and consulting to help pharma teams interpret and implement Good AI Practice (GxP-AI) frameworks. Aligns AI systems with FDA/EMA inspection-readiness standards.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Enterprise platform access — full simulation and modeling suite |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels9 records
InSilicoTrials product offering
Product offeringCore offering
InSilicoTrials provides a cloud-based computational modeling and simulation platform that enables drug developers to run in silico clinical trials before initiating human studies. The platform integrates mechanistic models (QSP, PBPK, PK/PD), AI/machine learning, digital twin technology, synthetic data generation, and a multi-agent AI orchestration layer (IRIS) to simulate drug behavior and clinical trial outcomes. It also includes an operations platform for trial planning, cost modeling, scenario forecasting, and resource optimization.
Product overview
InSilicoTrials offers a unified end-to-end in silico clinical trial platform combining mechanistic models, AI, digital twins, and operational tools. The platform consists of two core products: the Scientific Platform (for clinical trial simulation, virtual patients, and model/data libraries) and the Operations Platform (for trial planning, cost modeling, and resource optimization). Key modules include IRIS for multi-agentic workflow orchestration, a Model Library with 500+ validated QSP/PBPK/PK/PD frameworks, a Data Library covering 500M+ patients, and MOL2CLIN for oncology molecular-to-clinical translation. The platform is aligned with FDA and EMA guidelines and integrates with Microsoft Discovery for enterprise workflows.
Differentiator
Problem solved
Functional benefit
Brands
- IRIS: InSilicoTrials Research Intelligent System - multi-agent layer over simulation core that reads protocols, proposes scenarios, runs parallel simulations, and returns optimized trial designs.
- MOL2CLIN
Products and services
- Scientific Platform Clinical trial simulation platform providing virtual patients, model and data libraries with 500+ validated QSP, PBPK, PK/PD modeling frameworks for drug development. Used by pharmaceutical and biotechnology researchers to simulate trial outcomes before first patient enrollment.
- Operations Platform Trial planning, cost modeling, scenario forecasting, and resource optimization platform integrated with the scientific simulation platform in a unified environment. Used by pharma and biotech teams to plan and forecast trial execution.
- IRIS (InSilicoTrials Research Intelligent System) Multi-agentic simulation workflow orchestration system that reads clinical trial protocols, proposes scenarios, runs simulations in parallel, and returns optimized trial designs with evidence trails. Connects every model, dataset, and decision in an intelligent orchestration loop.
- MOL2CLIN Enterprise oncology simulation module integrated with Microsoft Discovery. Simulates how a compound behaves in patients by integrating pharmacokinetics, target engagement, tumor growth, safety, and virtual clinical trial outcomes from molecular structure input. Built for oncology drug development teams.
- AI-Driven Safety Assessment Suite Drug safety assessment suite offering PBPK & QSP models for virtual populations, PK & ADME predictions, blood-brain barrier penetration predictions, ICH-compliant QSAR models for mutagenicity/genotoxicity prediction, and immunogenicity risk screening. Used by pharma R&D teams for preclinical safety evaluation.
- AI Compliance Readiness Program
Quantifiable outcome
- Up to 90% efficiency in specific R&D activities through in silico trials
- +5 more outcomes
Companies that use InSilicoTrials
Customer profileNamed customers12 records
Segments5 records
Ideal customer profiles4 records
InSilicoTrials technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability12 records
Feature8 records
InSilicoTrials partnerships and signals
Strategic signalPartnerships
26 partnerships are on record, tiered core, minor and strategic.
- Microsoft DiscoverycoreMOL2CLIN module integrated with Microsoft Discovery platform — an enterprise agentic R&D platform combining agentic orchestration, graph-based scientific knowledge, advanced AI reasoning, and Azure HPC for end-to-end oncology drug discovery and development.
- The Jackson LaboratorycoreLeading partner in the CARDIOVERSE initiative ($30M ARPA-H funding), developing virtual heart models for cardiac safety prediction. InSilicoTrials leads the consortium with The Jackson Laboratory as the primary partner, combining computational modeling with genetic and physiological expertise.
- The New York Stem Cell FoundationcoreConsortium partner in CARDIOVERSE initiative, contributing stem cell expertise to develop physiologically representative virtual heart models for diverse populations.
- UConn HealthcoreConsortium partner in CARDIOVERSE initiative, contributing clinical and biomedical research expertise for virtual heart model development.
- University of MichigancoreConsortium partner in CARDIOVERSE initiative, contributing academic research capabilities and clinical expertise for cardiac safety modeling.
- AVL PartnersminorAVL Partners extends simulation offering for the healthcare industry through distribution of InSilicoTrials' platform capabilities.
- Microsoft for Startups Pegasus ProgramstrategicInSilicoTrials joins Microsoft for Startups Pegasus Program, accessing enterprise-grade cloud tools (Azure HPC) and go-to-market support to accelerate AI-driven drug development platform adoption.
- COSBI (Columbus Open Systems for Biomedical Innovation)coreExpanded platform with advanced predictive models from COSBI. Strategic partnership combining mechanistic modeling and AI-driven simulation to build regulatory-grade computational infrastructure for drug development.
- Axoltis PharmacoreSEALS Phase II clinical trial (NX210c for ALS) incorporates InSilicoTrials' virtual patient modeling to create statistical enrichment of the placebo group through in silico patients based on computational methods of historical control data.
- Telomir PharmaceuticalsstrategicCollaboration applying cutting-edge AI and simulation technologies to optimize Telomir-1 (telomere-lengthening drug for age-related conditions), improving its safety profile and reducing development costs.
- MIRA PharmaceuticalsminorMIRA Pharmaceuticals released breakthrough data from AI simulations in collaboration with InSilicoTrials, advancing their drug development program.
- Biofarma GroupminorCollaboration exploring benefits of in silico technology for clinical research. InSilicoTrials analyzed and reinterpreted clinical trial data for Epatrex (NAFLD dietary supplement) using computational modeling.
- METASTRA (EU Horizon Europe)strategicEU Horizon Europe project (€6.7M, 5 years) developing AI and physiology-based mechanical computational models to stratify cancer patients with vertebral metastases at high fracture risk. Coordinated by University of Bologna with 15 partners.
- Axoltis PharmacoreCollaboration to advance therapeutic solutions for neurological disorders (CNS). InSilicoTrials provides computational modeling for NX210c (ALS/Parkinson's drug candidate), including synthetic control arms and disease progression simulation in virtual subjects.
- COSBIcoreStrategic partnership combining COSBI's mechanistic modeling expertise with InSilicoTrials' AI-driven simulation platform to build regulatory-grade computational infrastructure for drug development.
- IBSA GroupstrategicMulti-year collaboration integrating AI-driven simulation into IBSA Group's preclinical and clinical development pipelines.
- AchilleS VaccinesstrategicCollaboration combining computational vaccine design with advanced monoclonal antibody modeling tools to tackle infectious diseases with limited therapeutic options.
- Health Campus LimburgminorInSilicoTrials established presence at Health Campus in Limburg, Belgium, joining an innovation hub focused on advancing life sciences and digital health in the region.
- Premier ResearchstrategicPremier Research embeds InSilicoTrials' platform into its rare-disease CRO offering, providing sponsors with simulation-led regulatory strategy to reduce development timelines.
- LSD (Limburgs Stan Dageraad)minorPartnership to accelerate digital transformation for biotech companies, combining laboratory and computational expertise to streamline drug development workflows.
- RCPE (Research Center Pharmaceutical Engineering)coreCollaboration to digitalize and accelerate pharmaceutical manufacturing process development. RCPE and InSilicoTrials expanded XPS simulation software with new tablet coating simulation module. FDA purchased the XPS license as an in-house simulation tool.
- MedactaminorPartnership to apply computational simulation to orthopedic medical device development, accelerating regulatory submissions and reducing animal testing requirements.
- TakedacoreTakeda, RCPE, InSilicoTrials, and University of Graz partnered to optimize biopharmaceutical manufacturing processes through computational modeling, targeting fill-and-finish process optimization.
- In Silico World Consortiumstrategic17-partner EU Horizon 2020 consortium coordinated by University of Bologna (€7.6M funding) developing 11 in silico trials solutions for medical devices, medicinal products, and advanced therapies. InSilicoTrials leads business opportunity analysis and commercial exploitation.
- BRAINTEASER (EU Horizon 2020)strategicEU-funded project developing AI algorithms to predict progression of ALS and Multiple Sclerosis. InSilicoTrials contributes computational modeling and simulation capabilities; organizes iDPP@CLEF open evaluation challenge.
- SimCardioTest (EU Horizon 2020)strategicEU Horizon 2020 project developing in silico trials for cardiovascular diseases, specifically targeting coronary stenosis and cerebral aneurysms.
Scale indicators6 records
Recent moves7 records
Expansion highlights5 records
InSilicoTrials competitors and assessment
Company assessmentDirect peers
- Certara: Public biosimulation software company offering PBPK, QSP, PK/PD modeling and regulatory science services to pharma — directly competes with InSilicoTrials' core modeling and simulation stack, but with a much larger installed base and broader regulatory services portfolio.
- Simulations Plus: Provider of PBPK, QSP, and pharmacokinetic modeling software (GastroPlus, MonolixSuite) plus AI-enabled drug discovery tools — competes head-to-head with InSilicoTrials on mechanistic modeling and clinical trial simulation for pharma R&D.
- GNS Healthcare: AI-driven causal simulation platform for clinical trial simulation, synthetic control arms, and precision medicine — directly comparable in silico trials value proposition with focus on oncology and immunology.
- Rosa & Co. Physiological modeling and QSP consulting firm serving pharma R&D — smaller, services-led peer with overlapping PBPK/QSP modeling capabilities and similar biotech and pharma customer base.
- Physiomics: UK-based QSP and systems biology consulting firm applying mechanistic modeling to oncology drug development — comparable offering with similar SMB profile and pharma/biotech customer segments.
- Metrum Research Group: Quantitative pharmacology services and modeling & simulation software (MonolixSuite reseller historically) — comparable QSP/PK/PD services competitor serving pharma and biotech clients.
Broad incumbents
- Schrödinger: Computational chemistry and physics-based simulation platform with a strong life sciences franchise (including a recently launched clinical trial simulation offering) — broader portfolio spanning drug discovery and materials science, with deeper capital and brand.
- Evidera (PPD / Thermo Fisher): Outcomes research and health economics arm of PPD providing modeling and simulation services including PBPK/QSP — broad incumbent in clinical evidence generation with overlapping pharma customer base.
Emerging players
- Recursion: AI-native drug discovery company combining high-throughput biology with machine learning — adjacent competitor pursuing in silico approaches to pharma R&D, though primarily asset-focused rather than platform-selling.
- Insilico Medicine: AI drug discovery company using generative AI and multi-modal models to identify targets and design molecules — adjacent competitor in computational drug development with a similar name, but focused on proprietary pipeline rather than platform sales.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
InSilicoTrials social profiles
Digital presenceInSilicoTrials compliance and trust
Trust signalCompliance4 records
InSilicoTrials financial estimates
Financial estimateRevenue estimate
Valuation estimate
InSilicoTrials leadership team
Management profileNumber of profiles
Profiles11 records
InSilicoTrials funding detail
Funding detailFunding overview
Funding rounds4 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
InSilicoTrials M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about InSilicoTrials
What does InSilicoTrials do?
InSilicoTrials provides a cloud-based computational modeling and simulation platform that enables drug developers to run in silico clinical trials before initiating human studies. The platform integrates mechanistic models (QSP, PBPK, PK/PD), AI/machine learning, digital twin technology, synthetic data generation, and a multi-agent AI orchestration layer (IRIS) to simulate drug behavior and clinical trial outcomes. It also includes an operations platform for trial planning, cost modeling, scenario forecasting, and resource optimization.
Is InSilicoTrials a public or private company?
InSilicoTrials is a private company. It is classified as venture growth investor backed and is currently operating.
When was InSilicoTrials founded?
InSilicoTrials was founded in 2016. It employs 11 to 50 people.
Where is InSilicoTrials based?
InSilicoTrials is headquartered in Trieste, Italy, in the Europe region.
How does InSilicoTrials make money?
Three revenue lines are on record. Software Platform Subscription / SaaS are the primary driver. The others are strategic Research & Development Partnerships and regulatory & Compliance Consulting Services.
Who are InSilicoTrials's main competitors?
Direct peers on record are Certara, Simulations Plus, GNS Healthcare, Rosa & Co., Physiomics and Metrum Research Group. Broad incumbents are Schrödinger and Evidera (PPD / Thermo Fisher). Emerging players are Recursion and Insilico Medicine.
Does InSilicoTrials have an API?
No public API is recorded for InSilicoTrials.
What industry is InSilicoTrials in?
InSilicoTrials's product category is Pharmaceutical R&D Simulation Software. Its primary akta.pro industry code is HLAGAFAM, In Silico / Computational Toxicology & PK/PD Modeling, with a secondary code of HLAGAJAO, AI/ML Platforms for Drug Discovery & Experiment Optimization. Its NAICS code is 54151 and its SIC code is 8731.