Certara IQ

Certara IQ™ is an AI-enabled quantitative systems pharmacology (QSP) modeling software platform designed for scientists, modelers, and drug development teams across biotech, pharma, and CROs. By integrating advanced technologies with validated models and standardized workflows, Certara IQ makes QSP modeling more accessible, scalable, and collaborative — empowering teams to make data-driven decisions that accelerate discovery, prioritize promising candidates, reduce development risk, and enhance clinical outcomes.

Built on the expertise of the world's largest global QSP consulting team, Certara IQ embeds decades of scientific knowledge directly into every step of the modeling process. The platform streamlines model creation and documentation, reduces errors, and leverages cloud deployment with full audit tracking to support quality assurance and regulatory rigor from discovery through submission.

Core Platform Capabilities

• Pre-validated library of QSP models available for immediate use across diverse therapeutic areas and pharmacologies
• Standardized workflows and reporting templates to ensure consistency and reduce manual effort
• Cloud-based platform enabling high-performance simulation and analysis at scale
• Intuitive model-building interface with AI-enabled validation tools
• Graphical and declarative tools that equip users of all skill levels to build, explore, and understand pharmaceutical models
• Full audit tracking for quality assurance and compliance
• Integration with Certara.AI to support AI-driven insights and automation throughout the modeling process

Scientific Modules: QSP Platform Models

• Immuno-Oncology Simulator: Predicts optimal combinations, dose regimens, and biomarkers in virtual patients for IO therapies
• Inflammatory Bowel Disease (IBD) QSP Model: A mechanistic multi-state mathematical model used to predict disease activity scores
• Immunogenicity (IG) Simulator: Predicts immunogenicity incidence and its impact on PK/PD for biotherapeutics
• Vaccine Simulator: Uses QSP to determine optimal vaccine dosing strategies for patients
• Neuroscience QSP Models: Mechanism-based models supporting drug discovery for Alzheimer's, Parkinson's, psychotic disorders, and more

QSP Pharmacology Model Packs

• ADC Model Pack: Multiple validated QSP models for monospecific and bispecific antibody-drug conjugates (ADC), with and without avidity
• Avidity Model Pack: Validated QSP models covering soluble and membrane ligand pharmacologies with avidity
• Biotherapeutic Model Pack: A library of monospecific and bispecific, single- and multi-compartment validated QSP models for biotherapeutics
• Cell Engager Model Pack: Validated QSP models for solid tumors, in vitro experiments, and solid tumors with two cell types
• Gene Therapy Model Pack: Eight validated QSP models covering gene therapies including LNP-encapsulated mRNA and siRNA
• Protein Degrader Model Pack: Validated QSP models for protein degrader pharmacologies such as PROTACs and Molecular Glue Degraders

Supported Pharmacology and Disease Areas

• Pharmacology models covering monospecifics and bispecifics, cell engagers, protein degraders, ADCs, and gene therapies
• Disease models spanning immuno-oncology, immunogenicity, neuroscience, inflammatory bowel disease, and vaccines
• Predefined workflows for First-in-Human studies and recommended Phase 2 dose selection

Key Benefits of Certara IQ

• Democratized QSP modeling: Supports both building models from scratch and leveraging pre-validated libraries, enabling users to tailor their approach to each drug program's needs regardless of prior QSP expertise
• Scalable for speed and volume: Enables researchers to simulate multiple what-if scenarios and run intensive calculations rapidly, supporting hypothesis testing and decision-making throughout the drug development pipeline
• Collaborative and unified: Unifies QSP modeling on a single platform, removing silos and enabling teams to build, scale, and reuse models with speed and confidence
• Regulatory-ready: Designed with regulatory rigor and compliance in mind, supporting every stage from discovery to regulatory submission

Certara IQ is delivered as a cloud-based platform and is structured around functional modules — Design, Analyze, and Explore — alongside its scientific model libraries, all integrated with Certara.AI capabilities. The platform is suited for organizations seeking to scale QSP modeling operations while maintaining the scientific rigor and documentation standards required for regulatory submissions.