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Clinical Pharmacology and Translational Medicine

Precision strategies and consultation for confident drug development

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Confidence in clinical pharmacology and translational medicine

Clinical pharmacology is critical because the precision of your decisions is everything. To get you there, Certara offers tailored, model informed drug development (MIDD) strategies. Our team comprises industry experts and former regulators who give you timely and accurate guidance. This ensures that you fulfil rigorous expectations, anticipate challenges, and drive development with confidence.

Confidence in innovation

Challenge the status quo. Predictive simulation enables you to look for innovative pathways.

Confidence in submission

We provide results that regulatory agencies trust. In fact, the majority have adopted our technologies.

Confidence in success

Our platforms and consulting avoid trial design errors and maximize your chances of success.

Clinical pharmacology and translational medicine services

Optimize your clinical trials with Certara's Phase 1 Clinical Pharmacology Services. Comprehensive study design, execution, and regulatory support to ensure success.

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Partner with Certara for Clinical Pharmacology Regulatory Strategy to optimize drug development pathways and navigate complex regulatory landscapes.

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Streamline first-in-human studies with physiologically based modeling to optimize dosing and reduce trial risks.

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Our nonclinical & clinical DMPK & ADME Consulting Services support a wide range of offerings to advance early drug development.

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Our Early Phase Clinical Development solutions provide expert support at every stage, from Candidate Selection through Phase 1.

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Meet our clinical pharmacology experts

Tong Zhu, PhD, FCP
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Experts

Tong Zhu, PhD, FCP

VP, Global Head, Clinical Pharmacology & Translational Medicine Certara Drug Development Solutions

Dr. Tong Zhu has over 25 years of experience specializing in translational medicine, early development, and clinical pharmacology. She has a wealth of knowledge in pharmaceutical research and development. She was responsible for leading Astellas’ Primary Focus strategy in Mitochondria Biology by working globally to help identify and develop i...

Mayumi Hasegawa, PhD
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Experts

Mayumi Hasegawa, PhD

Senior Director, Integrated Drug Development

Dr. Hasegawa has over 18 years of drug development experience focused on the areas of clinical pharmacology, pharmacometrics and specializes in development for Asia Pacific regions (APAC; Japan-Korea-Taiwan).

Dr. Hasegawa has experience in both early and late development programs across therapeutic areas of Oncology/Immunology, Rheumat...

Elliot Offman, BSc Pharm, MSc, PhD
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Experts

Elliot Offman, BSc Pharm, MSc, PhD

Vice President, Clinical Pharmacology & Translational Medicine, Certara Drug Development Solution

Dr. Offman has over 20 years of drug development experience and joined Certara in 2017 where he leads translational pharmacokinetic and pharmacodynamic efforts in Certara’s Clinical Pharmacology & Translational Medicine group.

Translational medicine expertise

Clinical pharmacology and translational medicine are Certara’s most highly rated core competencies in terms of analysis, expertise and experience.

250
project collaborations
650
leading experts
90
Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2024.
10
year average tenure for top 30 customers

Clinical pharmacology and translational medicine resources

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On-Demand Webinar

What does the Clinical Pharmacology Plan for a Biologic Look Like?

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and safe therapeutic solutions for patients. Due to their molecular and biological specificities, their clinical and...
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Publication

INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease

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Poster

Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease

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Blog

Dose Optimization Considerations for Targeted Radiation Therapies

The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio by Bristol Meyer Squibb have sparked investors’ interest in this therapeutic class. A growing number...
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Transform your early clinical strategy today

Take the first step toward efficient, compliant, and impactful clinical pharmacology. Schedule a consultation to see how Certara can partner with you for success.

Simulate pharmacodynamics and pharmacokinetics through evidence-based modeling
Optimize your trial design by anticipating outcomes
Break the status quo by exploring innovative pathways