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.
The rollout of eCTD v4.0 is accelerating. Timing for this industry-wide transition is no longer in the distant future but rather now. One health authority is already live, one is going live this year (2024), and multiple are planning to implement within the next year. Certara has hosted webinars on eCTD v4.0, held GlobalSubmit user … <a href="https://www.certara.com/webinar/answers-to-the-top-ectd-v4-0-questions-in-2024/">Continued</a>
Everyone loves a good story. Stories are more likely to move and engage people than mere facts and figures. Good storytelling is especially important in the healthcare sector for communicating the benefits, outcomes, and human experiences associated with healthcare practices, treatments, and interventions. It is an essential tool to foster better communication, build trust, enhance … <a href="https://www.certara.com/webinar/apac-mastering-value-storytelling-in-healthcare-leveraging-digital-tools-to-meet-stakeholders-expectations/">Continued</a>
Everyone loves a good story. Stories are more likely to move and engage people than mere facts and figures. Good storytelling is especially important in the healthcare sector for communicating the benefits, outcomes, and human experiences associated with healthcare practices, treatments, and interventions. It is an essential tool to foster better communication, build trust, enhance … <a href="https://www.certara.com/webinar/eu-mastering-value-storytelling-in-healthcare-leveraging-digital-tools-to-meet-stakeholders-expectations/">Continued</a>
While Case Report Forms (CRFs) have been traditionally used to collect patient data, the use of non-CRF data is increasing in modern clinical trials. In fact, over 70% of clinical data now originates from non-CRF sources such as biomarkers, labs, and imaging. In this blog, we look at the role of non-CRF data in clinical … Continued
In this blog, we take a detailed look at LOINC Codes and SDTM. We look at several LOINC code examples and examine why it’s beneficial to use the codes alongside CDISC and NCI controlled terminology. We also include details of where to find the official LOINC codes list. What Are LOINC Codes Used For? LOINC … Continued
SDTM mapping can be one of the most challenging programming problems in a clinical trial build. It involves mapping datasets from a non-CDISC structure, for example the structure used in your clinical data management system, to the CDISC SDTM structure, as required by CDISC standards. These standards were put in place to make it easier … Continued
From candidate selection to market we provide global, multi-functional development strategy and decision making, as well as program design and execution
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Leverage innovative approaches like adaptive trial design and advanced biostatistics for more rapid, better informed clinical decisions.
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Accelerating the approval of medical innovations through a unique combination of technology-enabled document authoring with deep regulatory, scientific, and operations expertise.
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Enable key decisions from First-in-Human to approval with Certara's leading quantitative analysis and predictive modeling solutions
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Demonstrate product value with market access strategies, analytics-driven evidence generation, advanced modeling and RWD solutions.
Learn MoreCertara 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.
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.
Cloud suite of unified clinical data standardization, compliance and automation solutions to increase the speed and quality of clinical trial submission data.
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The global leader in software for preparing clinical trial data for regulatory submission.
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Simcyp PBPK models describe the behavior of drugs in different body tissues, with each tissue considered a physiological compartment.
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The platform, used by over 6,000 discovery scientists for small molecule and biologics research, provides self-service data access and integrated analysis solution.
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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 MoreBackground Model Diagram Pembrolizumab: Available Clinical PK-Efficacy Data Data used for model calibration are from doses of 0.005, 0.02, 0.06 mg/kg (Patnaik, A. et al, Clinical Cancer Research, 2015) Data used for model calibration are from doses of 1, 3, 10 mg/kg (Pembrolizumab BLA) Efficacy for Pembrolizumab is near maximal when dose is > 1 … Continued
Discover how an IO-focused biotech expedited the clinical development of novel therapeutics for patients, all while trimming expenses, by applying strategic modeling solutions. Our partner is a small-sized clinical-stage biotechnology company, focusing on developing oncology therapies. They have various products in their pipeline focused on activating the immune system or inhibiting key oncogenic drivers over … Continued
In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Nurtec™ (Rimegepant) for the acute treatment of migraines in adults. In May 2021 the FDA also approved Nurtec™ for the prevention of migraine. Nurtec™ was approved in the European Union (EU) for both prevention and acute migraine treatment in April … Continued
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.
