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IQ™

Validated QSP modeling software and models to optimize drug discovery and development

AI-Enabled QSP Modeling Delivers Insights Faster

Certara IQ is an AI-enabled quantitative systems pharmacology (QSP) modeling product that integrates advanced technologies with validated models and workflows to enable more accessible and scalable QSP modeling. With Certara IQ, teams are empowered to make data-driven decisions that fast-track discoveries, prioritize the most promising candidates, reduce risk and enhance clinical outcomes.

Pre-Validated Library of QSP Models
Standardized Workflows and Reporting Templates
Cloud-Based Platform for High-Performance Simulation and Analysis
Intuitive Model-Building and AI-enabled Validation Interface

Certara IQ: Scalable, AI-Enabled QSP Modeling

Certara IQ transforms Quantitative Systems Pharmacology (QSP) modeling into a fast, more collaborative, and AI-enabled process. This video introduces how Certara IQ empowers scientists and modelers to build, run, and share QSP models at scale—accelerating drug discovery and development while enhancing decision confidence.

Modules That Power Scalable QSP Modeling

Comprised of several functional and scientific modules

Scientific

Pharmacology models
Workflows

First-in-Human
Recommended Ph2 dose

AI sources

Functional

Design
Analyze
探索
Certara.AI

QSP 平台模型

Certara offers Quantitative Systems Pharmacology (QSP) platform models across diverse therapeutic areas, enabling data-driven insights to accelerate drug development. Our tailored solutions integrate complex biological systems to support informed decision-making in research and clinical settings.

Immuno-oncology Simulator

Certara’s QSP modeling platform for immuno-oncology predicts optimal combinations, dose regimens, and biomarkers in virtual patients, for IO therapies.

Inflammatory Bowel Disease (IBD) QSP Model

The Inflammatory Bowel Disease (IBD) QSP Platform Model is based on a mechanistic multi-state mathematical model to predict disease activity scores.

Immunogenicity (IG) Simulator

Certara’s Immunogenicity (IG) Simulator is a QSP immunogenicity prediction tool that predicts immunogenicity incidence and its impact on PK/PD.

Vaccine Simulator

Certara’s Vaccine Simulator uses Quantitative Systems Pharmacology (QSP) to determine optimal vaccine dosing strategies for patients.

Neuroscience QSP Models

Certara 针对神经科学药物研发的 QSP 模型提供基于机制的阿尔茨海默病、帕金森病、精神障碍等疾病研究工具。

Transforming QSP Modeling: Benefits at a Glance

Certara IQ transforms the way teams approach Quantitative Systems Pharmacology by removing barriers, accelerating workflows, and unifying modeling on a single platform. With intuitive tools, pre-built models, and AI-enabled automation, IQ empowers scientists across skill levels to build, scale, and reuse QSP models with speed and confidence. Designed with regulatory rigor and compliance in mind, it supports every stage of drug development, from discovery to submission.

Democratized QSP modeling

Certara IQ supports both building models from scratch and leveraging pre-validated libraries—empowering users to tailor their strategy to each drug program’s needs. By using graphical and declarative tools, Certara IQ equips all users to build, explore, and understand pharmaceutical models with the integration of complex biological systems, like never before.

Scalable for Speed and Volume

Researchers can simulate multiple what-if scenarios and run intensive calculations in record time, enabling rapid decision-making and hypothesis testing throughout the drug development pipeline. Certara IQ enables scalability of QSP modeling not just within a project and across the stages of the pipeline, but also across a portfolio.

Compliance for Regulatory Success

With templates and workflows designed for compliance, teams can efficiently generate reports and ensure model traceability for regulatory submissions.

AI-Driven Data Integrity Quality and Transparency

AI integration enhances model reliability and interpretability for both scientific peers and regulatory stakeholders, increasing confidence in model results.

Proven Impact in Global Drug Development

With over 100 projects and regulatory filings supported, Certara’s QSP and EFA frameworks have been trusted by biopharma leaders and regulators alike — demonstrating real-world validation and accelerating model-informed decisions across therapeutic areas.

100
Projects and regulatory filings by Certara IQ

See Certara IQ in Action

Certara IQ is the AI-enabled QSP modeling tool that will transform your research and scale your molecule’s potential.

Certara IQ offers flexible and scalable licensing options to cater to a variety of users and organization sizes. Ask us about licensing options.

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常见问题解答

Who is Certara IQ used by?

Scientists, modelers, clinicians, decision-makers, and regulatory teams involved in drug development can all benefit from using Certara IQ.

I’m interested in building a QSP model, but I don’t have the expertise.

Certara IQ’s pre-built templates and workflows help you get started quickly without deep modeling knowledge. The intuitive interface, declarative modeling features, and visualizations make it accessible to scientists, clinicians, and decision-makers who may not be expert modelers. This democratizes QSP modeling across teams.

What training do you provide for Certara IQ?

Certara IQ users benefit from expert-led onboarding, hands-on workshops, and comprehensive documentation. Certara’s global QSP experts provide ongoing support to help teams maximize the software’s impact.

Which therapeutic areas does Certara IQ support?

Certara IQ includes QSP models across oncology, immuno-oncology, neuroscience, inflammatory diseases, gene and cell therapies, and vaccines. Its pre-validated model libraries allow users to explore complex modalities without starting from scratch.

How does Certara IQ handle patient variability?

Certara IQ generates and simulates virtual patient populations, reflecting biological and clinical variability. This capability helps assess inter-patient response differences, guide stratification, and design more predictive trials.

Why is using Certara IQ important when considering FDA and regulatory submissions?

The FDA has seen a steady increase in Quantitative Systems Pharmacology (QSP) submissions over the past decade, reflecting the growing role of model-informed drug development (MIDD). QSP models are now frequently used to support regulatory interactions, inform dose selection, and justify trial designs. In fact, FDA initiatives such as the Model-Informed Drug Development Paired Meeting Program explicitly encourage the use of mechanistic modeling approaches in submissions.

Certara IQ makes this process easier by providing validated QSP models, standardized workflows, and audit-ready documentation designed with regulatory compliance in mind. By using Certara IQ, teams can generate transparent, reproducible models that align with FDA expectations, helping to increase confidence in submissions and reduce delays.

What are the licensing options and the cost?

Certara IQ offers flexible and scalable licensing options suitable for organizations of any size. Contact us for more information on licensing and pricing.

Is Certara IQ connected to Certara Simcyp®?

No, Certara IQ is a separate solution, but complementary to Simcyp.

How does Certara IQ use AI?

AI accelerates workflows, assists in model building, and helps interpret complex results.

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