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Drug Development’s New Model: Biosimulation from Discovery to Label Expansion

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Thursday, February 29, 2024

TECH-ENABLED SERVICES

Unmatched Experience and Expertise

Our drug-development consultation services reflect decades of experience from more than 650 healthcare and pharmaceutical professionals, as well as leading-edge technological solutions. This combination delivers the insights and knowledge to accelerate regulatory and commercial success while saving time and money.  Over the last decade, we have worked on more than 7,000 customer projects, across practice areas and drug development phases, leading to the extensive experience our customers highly value.

EXPLORE SERVICES

PROPRIETARY SOFTWARE

Leading the Industry in Drug Discovery and Development

Our quantitative approach to model-informed drug development offers a comprehensive view of the clinical and regulatory possibilities and challenges facing new therapies.  We derive significant insights that inform the development of our biosimulation software. These insights help us to anticipate and align our technology roadmap with our customers’ needs and priorities.  By providing the clearest picture of both opportunities and risks in the development lifecycle, we remove doubt and inspire confidence at key milestones during the process.

BROWSE 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.

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Phoenix Pharmacokinetic / Pharmacodynamic Platform

Phoenix Pharmacokinetic / Pharmacodynamic Platform

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

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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.

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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.

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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.

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SCIENTIFIC CONTENT

Transforming the Future of Drug Development

Our goal is to not only push the boundaries of what’s possible through medical therapies and devices, but also to challenge the thinking that drives regulatory science. 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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Strategy to overcome clinical pharmacology challenges for regulatory approvals [APAC Webinar]

Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications. Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of &hellip; <a href="https://www.certara.com/webinar/strategy-to-overcome-clinical-pharmacology-challenges-for-regulatory-approvals-apac-webinar/">Continued</a>

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The 15th Japan Safety Pharmacology Society

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European Collaboration on Health Technology Assessment(HTA): The New Road to Access
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How to Navigate the FDA Landscape for an Orphan Drug

Rare diseases are a public health priority. FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.

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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

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Accelerating a drug launch with value communication technology and an integrated workflow
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FEATURED CASE STUDIES

Success is Achieved Together

Biosimulation can reduce the size of and cost of human trials, the most expensive and time-consuming part of drug development.  In some cases, we can eliminate certain human trials completely.   More than 2,000 customers worldwide choose us as their partner for biosimulation software and technology-driven services. See how we have helped companies like yours redefine what’s possible for safe and effective modern medicine.

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