Endocrinology

Endocrinology

Endocrinology: Strategic Modeling and Simulation Services Certara has broad expertise in endocrine diseases including diabetes, obesity, hypogonadism, and hypoparathyroidism. For example, our scientists have supported diabetes development programs for industry clients, from pre-clinical to Phase 4 commercial strategy. Our consultants have addressed critical issues in trial design, dose selection, extrapolation from animal to human, and development […]

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Central Nervous System

Central Nervous System: Strategic Modeling and Simulation Services Certara has extensive experience supporting Central Nervous System (CNS) projects for industry clients, spanning all phases of clinical development. Our consultants have addressed key issues in trial design, choice of indication, and development strategy for drugs with novel mechanisms of action. We have developed models for assessing […]

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Cardiovascular

Cardiovascular: Strategic Modeling and Simulation Services Certara has extensive experience in modeling and simulation to support cardiovascular drug development across all phases of clinical development. Our consultants have addressed key issues in trial design, dose selection, and development strategy for a broad range of cardiovascular diseases and conditions, including pulmonary arterial hypertension (PAH), congestive heart […]

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Therapeutic Areas

Therapeutic Areas of Expertise: Strategic Drug Development Services Certara’s global consulting team has unparalleled experience across all development phases and in all major therapeutic areas. We have collaborated with sponsors, both large and small, to provide insight into key decisions, including dosing and toxicity, efficacy and biological impact, comparative effectiveness, clinical trial design, regulatory strategy, and […]

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Clinical Trial Outcomes Databases

Clinical Trial Outcomes Databases Quantify Your Competitive Edge Along the development path of a compound, sponsors make critical decisions to ensure drug approval and market success. Success depends not only on the drug’s performance, but also on the competitive landscape, requiring reliable assessments—now and for the future—of your competition. Gain Faster Time to Insight What […]

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Orphan Drug Development

Orphan Drugs: Unique Challenges Require Unique Development Approaches Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patient populations are difficult to identify and recruit for clinical trials. Many orphan diseases are genetic. Often these patients have complex phenotypes that react very differently to proposed treatment […]

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Pediatric Drug Development

Understanding Drug Effects in Children Pediatric drug development continues to be a vexing challenge, yet pediatric research is increasingly being mandated by regulators and patients alike. Traditional development methods can be problematic for ethical and logistical reasons. Children are a heterogeneous population, especially neonates and infants, as organ maturation affects drug exposure and response. Leveraging […]

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Label Optimization

Drug Label Optimization Using Proven Modeling and Simulation Methodology The drug label is the culmination of years of work and millions, if not billions of dollars. Every inclusion and exclusion on that label will have a direct impact on the drug’s profitability. While modeling and simulation have been an important element in drug development for some time, […]

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Benefits of Modeling and Simulation

The Benefits of Modeling and Simulation in Drug Development Modeling and simulation, also known as “model-informed drug development,” has already had a profound impact on drug development, yet its full impact is just now coming to light.  Modeling and simulation (M&S) has the proven ability to influence every phase of the drug development process, including […]

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PK/PD Modeling and Simulation

Phoenix: The Most Comprehensive and Widely-used Software for Pharmacokinetic (PK), Pharmacodynamic (PD), and Toxicokinetic (TK) Modeling and Simulation Phoenix®, the industry’s premier PK/PD modeling and simulation software workbench, is used by over 6,000 scientists in 60 countries at nearly 2,000 institutions, including the top 50 global pharmaceutical companies, academic institutes, and research foundations. Regulatory agencies, including 11 divisions […]

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Model-based Meta-analysis

An Innovative Strategy to Make Better Use of Available Data The difference between getting a new medication to patients, and it ending up in the scrap heap of failed programs lies in making the right choices. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How […]

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Contact Us

Global Sales To better serve your request, please use the “contact us” form on the right. Drug Development Software US – 888-708-7444 Japan – +81 3 6432 4890 Europe – +49 3020143640 Drug Development & Pharmacometrics Consulting US – 973- 729-4450 Simcyp Consortium UK – +44 (0) 114 460 0200 Regulatory Sciences and Software – […]

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About Our Solutions

Cutting Edge Modeling and Simulation Solutions for Drug Development Drug development has become more complex and multi-layered. New combination therapies require more precise and individualized analyses, new approaches such as “basket studies” evaluate potential disease targets through a new lens, safety issues are more challenging, and comparative effectiveness plays an increasingly important role in “go/no […]

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About Our Consulting Services

Why Partner with our Drug Development, Regulatory, and Clinical Pharmacology Experts? Committed to scientific, regulatory, and commercial advancement, Certara creates impactful solutions facing the biopharm industry today—speed and cost. The largest and most comprehensive provider of strategic drug development, modeling and simulation, and regulatory science services, Certara partners with you to optimize drug development and […]

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