AI TOOL PROFILE
Certara: Drug Development and Biosimulation Software
- Healthcare
- Clinical Trial Data Management
- Pharmaceutical companies
- Biotechnology companies
- Contract Research Organizations (CROs)
Pricing
Pricing was not clearly available from the provided evidence. Buyers should confirm current pricing on the vendor website.
At a glance
- Best for
- Pharmaceutical companies, Biotechnology companies, Contract Research Organizations (CROs)
- Key use cases
- Regulatory Submission Management, Dosing and Safety Prediction, Clinical Data Standardization, Drug Discovery Analysis, Market Access Strategy
- Official website
- Visit certara clinical trial outcomes databases official website
How AI is used
Certara is a suite of software and services designed to support the drug development lifecycle from discovery to market access. The platform focuses on biosimulation, predictive modeling, and clinical data management to help researchers make data-driven decisions regarding dosing and safety.
The software is primarily designed for pharmaceutical companies, biotech firms, and contract research organizations (CROs). It provides specialized tools for different phases, including preclinical research and late-stage clinical trials.
Capabilities include PBPK modeling for predicting drug behavior in diverse populations and tools for standardizing clinical data to meet regulatory requirements. The platform also includes an AI platform for life sciences and generative AI for regulatory writing.
Buyers should confirm which specific module fits their current phase of development, as the suite ranges from discovery informatics to market access and pricing strategy tools.
Key Features
Phoenix PK/PD Platform
Supports non-compartmental analysis (NCA), population PK, and toxicokinetic analysis and modeling.
Simcyp PBPK Simulator
Uses physiologically based pharmacokinetic modeling to predict drug behavior across diverse populations.
Pinnacle 21
Provides data standardization and validation to help ensure clinical data complies with CDISC standards.
GlobalSubmit eCTD Software
Supports the publishing, reviewing, and transmitting of electronic Common Technical Document submissions.
Certara.AI
An AI platform designed for life sciences to help address data silos and support analytics.
CoAuthor
Uses GenAI and structured templates to support regulatory writing.
D360 Scientific Informatics
Allows users to access, analyze, and visualize molecule and bioactivity data.
BaseCase
An interactive tool used to communicate data-driven value stories for market access.
Use Cases
Regulatory Submission Management
Using GlobalSubmit to publish and validate eCTD submissions.
Dosing and Safety Prediction
Applying Simcyp PBPK modeling to predict drug-drug interactions and dosing for specific populations.
Clinical Data Standardization
Utilizing Pinnacle 21 to verify that submission datasets adhere to SEND, SDTM, and ADaM formats.
Drug Discovery Analysis
Using D360 to manage and analyze chemical and biological data during the design-make-test-analyze cycle.
Market Access Strategy
Developing evidence-based pricing and reimbursement strategies using real-world evidence and health economic models.
FAQ
What does Certara software do?
- Certara provides a suite of tools for biosimulation, data-driven modeling, and regulatory submission management to help life sciences companies manage drug development.
Which regulatory agencies use Certara tools?
- Platforms like Simcyp, Phoenix, and Pinnacle 21 are used by agencies including the US FDA, Japan's PMDA, and the EMA.
Who is the target audience for Certara?
- The software is designed for pharmaceutical companies, biotech firms, and contract research organizations (CROs) across all phases of drug development.
Source category: Healthcare
Source subcategory: Clinical Trial Data Management
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