Core contributor across EU-ToxRisk, TransQST, eTRANSAFE, and RISK-HUNT3R — all focused on mechanism-based toxicity testing and safety prediction.
CERTARA UK LIMITED
Commercial biosimulation company specializing in computational toxicology, PBPK modelling, and next-generation drug safety risk assessment.
Their core work
Certara is a global leader in model-informed drug development and regulatory science, specializing in biosimulation, pharmacokinetics/pharmacodynamics (PKPD) modelling, and computational toxicology. Their core business is helping pharmaceutical companies predict drug safety and efficacy using quantitative systems pharmacology and PBPK (physiologically-based pharmacokinetic) models. In H2020, they contribute computational modelling expertise to large safety and toxicology consortia, building predictive models that reduce reliance on animal testing and accelerate drug development decisions.
What they specialise in
TransQST explicitly centres on translational quantitative systems toxicology and PBPK modelling; EU-ToxRisk uses biokinetics and computational modelling.
AOP-related keywords appear across EU-ToxRisk, eTRANSAFE, and RISK-HUNT3R, showing sustained work on mechanistic toxicity frameworks.
eTRANSAFE focuses on integrative knowledge management and data sharing standards (SEND data); RISK-HUNT3R integrates exposure modelling with toxicokinetics.
RISK-HUNT3R (2021-2026) explicitly targets human-centric next-generation testing strategies, their most recent and largest-funded project.
How they've shifted over time
In the early period (2016–2018), Certara's H2020 work centred on foundational computational toxicology — systems biology, PBPK modelling, and building mechanistic understanding of drug safety through projects like EU-ToxRisk and TransQST. By the later period (2019–2023+), their focus shifted decisively toward data integration, predictive modelling at scale, and next-generation risk assessment methods that move beyond animal testing. The evolution shows a company moving from contributing modelling tools to shaping how safety data is shared, standardised, and used for regulatory decisions across Europe.
Certara is moving toward integrated, human-centric safety assessment frameworks that combine computational models with regulatory-grade data standards — positioning them at the centre of Europe's shift away from animal testing.
How they like to work
Certara consistently joins as a specialist participant in large research consortia (120 unique partners across 18 countries), never leading as coordinator. Their projects average 20+ consortium members, indicating they operate as a trusted computational modelling provider embedded in major multi-partner initiatives. This pattern suggests they bring deep technical capability rather than project management — ideal for consortia needing industrial-grade biosimulation without the overhead of coordinating them.
With 120 unique consortium partners across 18 countries, Certara has one of the broadest collaboration networks in the EU drug safety research space. Their partners span pharma companies, regulatory agencies, universities, and research institutes across Europe, reflecting their position as an industry bridge in IMI/RIA-style public-private partnerships.
What sets them apart
Certara is not an academic group or a small biotech — it is a large commercial biosimulation company with regulatory-grade software platforms already used by pharma and agencies worldwide. This means they bring production-ready computational tools and industry data access that academic partners typically cannot. For consortium builders, Certara offers immediate credibility with regulators and a direct pathway from research models to real-world drug safety decisions.
Highlights from their portfolio
- RISK-HUNT3RTheir largest H2020 grant (EUR 695,625) and most recent project, directly targeting the EU's strategic goal of replacing animal testing with computational and human-centric methods.
- EU-ToxRiskA flagship European programme in mechanism-based toxicity testing (EUR 665,765 to Certara), establishing the foundational framework their later projects build upon.
- eTRANSAFEFocused on building shared infrastructure for translational safety data — represents Certara's shift from pure modelling toward data standardisation and interoperability.