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- ️Thu Feb 20 2025
“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.
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Machine Learning for Population PK Model Selection: Theory and Practice
March 03, 2025
What kind of model will strike the best balance of fit and parsimony for your PK data? A one compartment? Two or three? What about elimination? Is it linear, Michaelis-Menten, or TMDD? These are just two of the many structural considerations you face when building a popPK model. While known drug and subject characteristics may … <a href="https://www.certara.com/webinar/machine-learning-for-population-pk-model-selection-theory-and-practice/">Continued</a>
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Clear the Fog of Non-Clinical Research Data! Unlock SEND Explorer’s Latest Features for Smarter Decision-Making [China Webinar]
March 04, 2025
Non-clinical research data is crucial for drug development, informing decisions about safety, efficacy, and mechanism of action. But the complexity of this data presents significant challenges. SEND Explorer is a powerful software tool designed to streamline the interpretation of non-clinical data. With its advanced viewing, search, and visualization capabilities, SEND Explorer empowers researchers to efficiently … <a href="https://www.certara.com/webinar/clear-the-fog-of-non-clinical-research-data-unlock-send-explorers-latest-features-for-smarter-decision-making-china-webinar/">Continued</a>
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Phoenix in the Future: Unveiling the Product Roadmap and the New TFL Module [APAC Webinar]
March 06, 2025
Be among the first to experience the groundbreaking Tables, Figures, and Listings (TFL) Module in Phoenix Cloud. This innovative tool promises to transform the way you handle TFL creation and management, delivering swift results, unparalleled flexibility, and seamless teamwork. In this exclusive webinar, you’ll delve into key highlights, including: For whom the webinar will be … <a href="https://www.certara.com/webinar/exclusive-preview-discovering-the-new-tfl-module-in-phoenix-cloud-apac-webinar/">Continued</a>
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Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe February 28, 2025
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The Benefits of Real-Time Nonclinical Safety Data Analysis January 27, 2025
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Clinical Metadata Standardization: Evaluating the Importance of a Metadata Repository in Clinical Trials November 22, 2024
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How the US FDA MIDD paired pilot program helps sponsors February 28, 2025
For the past couple of decades, leading American institutions, pharmaceutical and biotechnology companies, as well as the US FDA have been using quantitative tools (model-informed drug development; MIDD) to further their understanding of drug development assets. This integrated armamentarium has fueled industry consortiums, public-private partnerships, as well as several regulatory guidance documents. In this blog, … Continued
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Gain Nonclinical Drug Safety Insights with Real-Time Data Analysis February 24, 2025
Efficient drug development relies on informed decision-making. For toxicologists, having timely access to nonclinical study data while studies are in progress is a game-changer. Imagine the ability to monitor research findings as they develop. This change would allow you to adjust study designs in the moment and provide actionable insights to your team. However, traditional … Continued
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Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC February 19, 2025
Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the clinical and nonclinical data on an investigational drug.
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
Biometrics and Data Sciences
Leverage innovative approaches like adaptive trial design and advanced biostatistics for more rapid, better informed clinical decisions.
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.
Pharmacometrics - Modeling and Simulation
Enable key decisions from First-in-Human to approval with Certara's leading quantitative analysis and predictive modeling solutions
Evidence and Access
Demonstrate product value with market access strategies, analytics-driven evidence generation, advanced modeling and RWD solutions.
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.
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.
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.
Phoenix™ Pharmacokinetic / Pharmacodynamic Platform
The global leader in software for preparing clinical trial data for regulatory submission.
Simcyp™ Physiologically Based Pharmacokinetic (PBPK)
Simcyp PBPK models describe the behavior of drugs in different body tissues, with each tissue considered a physiological compartment.
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.
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.
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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
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Streamlining the Preparation of 1-Year and 2-Year PSURs
Certara was engaged to assist a client with preparing a last-minute addition to a Periodic Safety Update Report (PSUR). During the process, Certara’s experts identified the need to prepare an additional 2-year PSUR to ensure compliance with the competent authority in another regulatory region. In this case study, we examine how we collaborated with the … Continued
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Delivering High-Quality, Timely Responses to EMA Safety Queries
A pharmaceutical company approached us for support with eight safety-related queries from the European Medicines Agency (EMA). The timescale to address the queries was three weeks. Below, we explore how we worked with the client to deliver high-quality responses to the EMA’s safety queries within this tight deadline. The challenges The eight EMA safety … Continued
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.