Skip to main content

Shape Certara’s Future

Your feedback matters. Share your insights today!

Take the Brand Survey

Your Trusted Partner for Key Decision Points

“Certara’s contribution to the drug development program for Nurtec ODT was substantial. Their clinical pharmacology representative worked seamlessly with the Biohaven Development Team. Certara’s considerable expertise in clinical pharmacology and pharmacometrics and flawless execution supported Nurtec’s clinical development team and helped to prepare the clinical pharmacology NDA components.” Richard Bertz, PhDVice President, Clinical Pharmacology & Pharmacometrics

LATEST CONTENT

Modeling the Future of Drug Development

Using model informed drug development strategies, advanced data, analytics and AI, and scientific expertise, we are committed to sharing our thought leaders’ insights and findings to question current approaches and envision what the future holds for biosimulation and public health.

RESOURCE LIBRARY

01

Where to Start? Setting Your Medical Writing Team Up for Success with GenAI

Generative AI (GenAI) is poised to revolutionize writing and report generation. In fact, industry studies have shown the use of GenAI can introduce efficiencies of up to 40% while providing the tools needed to provide a happier writing team. However, successful implementation of a GenAI tool within your medical or regulatory writing team doesn’t start &hellip; <a href="https://www.certara.com/webinar/where-to-start-setting-your-medical-writing-team-up-for-success-with-genai/">Continued</a>

Read More

01

DIA RSIDM 2025

Read More

01

Clinical Metadata Standardization: Evaluating the Importance of a Metadata Repository in Clinical Trials
Read More

01

Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters

Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A defect in the Frataxin (FXN) gene causes FA. FXN is essential for the proper functioning of the mitochondria, and its deficiency leads to mitochondrial dysfunction, oxidative stress, and neuroinflammation.   Patients develop ataxia, balance issues, loss of motor skills, speech impairment, weakness, visual impairment, … Continued

Read More
Drug Development and Regulatory Strategy and Stewardship

Drug Development and Regulatory Strategy and Stewardship

From candidate selection to market we provide global, multi-functional development strategy and decision making, as well as program design and execution

Learn More
Biometrics and Data Sciences

Biometrics and Data Sciences

Leverage innovative approaches like adaptive trial design and advanced biostatistics for more rapid, better informed clinical decisions.

Learn More
Regulatory Services & Medical Communications

Regulatory Services & Medical Communications

Accelerating the approval of medical innovations through a unique combination of technology-enabled document authoring with deep regulatory, scientific, and operations expertise.

Learn More
Pharmacometrics - Modeling and Simulation

Pharmacometrics - Modeling and Simulation

Enable key decisions from First-in-Human to approval with Certara's leading quantitative analysis and predictive modeling solutions

Learn More
Evidence and Access

Evidence and Access

Demonstrate product value with market access strategies, analytics-driven evidence generation, advanced modeling and RWD solutions.

Learn More

MODEL INFORMED DRUG DEVELOPMENT SOLUTIONS

Unmatched Expertise

Certara delivers advanced drug development solutions, empowering pharmaceutical and biotechnology companies to accelerate the journey from early research to successful market approval. Certara experts include some of the leading scientists in the world with seven of our scientists recognized as the top 2% most cited in their field*. The value to clients is working with the industry’s largest team of model informed drug developers to derisk projects, shorten timelines, reduce costs and enhance scientific understanding of how new therapies impact patients. With flexible operating models that support both expert teams of modelers in large pharma organizations to serving as a comprehensive drug development steward for emerging biotech startups, Certara delivers exceptional value that moves you forward faster.

EXPLORE SOLUTIONS

MIDD SOFTWARE PRODUCTS

Modern, AI-Enabled Software for Discovery & Development

Certara software products include industry gold standard offerings that have been used by more than 60,000 end users around the globe. Our goal is to lead the industry with advanced computing capabilities that change the model of drug development across discovery, biosimulation, and clinical data automation.

EXPLORE SOFTWARE

Pinnacle 21 Clinical Data Management & Automation Suite

Pinnacle 21 Clinical Data Management & Automation Suite

Cloud suite of unified clinical data standardization, compliance and automation solutions to increase the speed and quality of clinical trial submission data.

Learn More
Phoenix™ Pharmacokinetic / Pharmacodynamic Platform

Phoenix™ Pharmacokinetic / Pharmacodynamic Platform

The global leader in software for preparing clinical trial data for regulatory submission.

Learn More
Simcyp™ Physiologically Based Pharmacokinetic (PBPK)

Simcyp™ Physiologically Based Pharmacokinetic (PBPK)

Simcyp PBPK models describe the behavior of drugs in different body tissues, with each tissue considered a physiological compartment.

Learn More
D360™ Scientific Informatics Platform

D360™ Scientific Informatics Platform

The platform, used by over 6,000 discovery scientists for small molecule and biologics research, provides self-service data access and integrated analysis solution.

Learn More
Certara.AI Platform

Certara.AI Platform

Certara.AI allows you to solve data silo problems while improving analytics capabilities that drive productivity and accelerated data discovery across life science R&D.

Learn More

01

Helping Sponsor Meet EMA Policy 0070 Requirements

Background The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for Human Use, commonly known as EMA’s Policy 0070, requires drug companies to proactively share the results of their clinical trials in the public domain after receiving a Marketing Authorization Application (MAA) decision from EMA. Following a review of a … Continued

Read More

FEATURED CASE STUDIES

From Molecule to Market Accelerating Medicines Together

More than 2,300 life sciences companies including 23 global regulatory agencies worldwide choose Certara as their partner for MIDD solutions including biosimulation, data sciences software and expert drug development services. See how we have helped companies like yours redefine what’s possible for safe and effective modern medicine.

More Case Studies