Modern and new drug development is a team sport
Our drug development teams have collaborated with our partners on well over 250 programs, across all stages of drug development life cycle and in every therapeutic area from oncology to rare diseases.
Acting as your dedicated stewards, our best-practice, quantitative systems and integrated approach delivers significant time and cost savings while accelerating regulatory and commercial success. From clinical pharmacology to pharmacometrics to regulatory submission and strategy and market access, we have 650+ leading experts throughout the world who are dedicated to achieving your goals. Build your drug development dream team with Certara.
How we help our clients
Clinical Pharmacology
Our clinical pharmacology expertise is critical for optimizing safety and efficacy in drug development. Clinical pharmacology compromises more than 50% of a drug label.
New Drug Development and Regulatory Submissions
With our proven quantitative systems and integrated approach, we help to navigate the increasingly complex landscape of drug development to maximize your probability of success.
Model-based Meta Analysis (MBMA)
MBMA is a quantitative framework that uses PK/PD and statistical modeling to leverage external clinical trial efficacy, tolerability, and safety data to inform drug development decisions.
Pharmacometrics
Pharmacometrics uses mathematical and statistical models to quantify drug, disease, and trial information to help address critical drug development decisions.
Quantitative Systems Pharmacology (QSP)
Improve R&D productivity with QSP models, which predict how drugs modify cellular networks in space and time and how they impact and are impacted by human pathophysiology.
Quantitative Systems Safety and Toxicology
QSTS helps to characterize adverse drug reactions by describing modes of action as adverse outcomes pathways and perturbed networks versus conventional empirical end points and animal-based testing.
Simcyp Physiologically-based Pharmacokinetic (PBPK) Modeling
Our bespoke and leading PBPK modeling and simulation (M&S) consulting services help answer a range of questions without having to resort to a clinical study.
Virtual Bioequivalence (VBE)
Our Simcyp virtual bioequivalence services helped to achieve the first and only application where a complex generic was approved by the FDA without the need for a comparative clinical endpoint study.
Leveraging our best-in-class capabilities in modeling & simulation, regulatory science, and market access, we work alongside your team to inform critical decisions and set you up for regulatory and commercial success.
Agility, communication, quality, and trust are paramount to the success of our partnerships. Together with you, we are one, integrated and cohesive team that anticipates risks, creates a robust strategy, and delivers with seamless implementation.
Why do global pharmaceutical companies, biotechnology startups, and venture capital and private equity firms alike choose Certara?
- Our quantitative-driven approach. Using modeling and simulation across the entire drug development life cycle, we help to de-risk your program, increase confidence in critical decisions, and help you reach your goals, smarter and faster
- Our people. We have the most experienced (and largest) team of experts with clinical pharmacologists, pharmacometricians, and regulatory scientists and writers, that is dedicated to achieve your success
- Our proven track record. We have a library of case studies on our successful collaborations in oncology, rare diseases, infectious diseases, neurodegenerative diseases, and more.
Dr. Patrick F. Smith is President of Integrated Drug Development at Certara, where he leads a global team of drug development scientists that creates value for clients across the entire life cycle and ultimately accelerates patient access to medicines. With more than 20 years of drug development experience, Patrick has worked across all phases of drug development with deep expertise in infectious diseases, oncology, and inflammation as well as novel early development program design and applying modeling and simulation to solve critical development problems.
Previously, Patrick was co-founder of d3 Medicine (acquired by Certara in 2016), helping to build a healthcare company that specialized in providing strategic support for complex development programs. Prior to d3 Medicine, Patrick was U.S. Clinical Pharmacology Lead at Roche for more than 5 years, where he worked in various roles of increasing responsibility in clinical pharmacology and translational medicine. He has served as an Associate Professor at the University at Buffalo School of Pharmacy and Roswell Park Cancer Institute in Buffalo, NY. Patrick has published more than 125 peer-reviewed articles in journals, including the New England Journal of Medicine and Lancet. He received his PharmD at the University of California, San Francisco and completed his clinical residency at Duke University Medical Center.
Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing. She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).
Rik’s key interests are in the integration of model-based components with overall clinical pharmacology and clinical development deliverables throughout the development trajectory. He enjoys combining his analytical skills and creativity in designing efficient drug development strategies that address the right questions at the right time.
Dr. Patrick F. Smith is President of Integrated Drug Development at Certara, where he leads a global team of drug development scientists that creates value for clients across the entire life cycle and ultimately accelerates patient access to medicines. With more than 20 years of drug development experience, Patrick has worked across all phases of drug development with deep expertise in infectious diseases, oncology, and inflammation as well as novel early development program design and applying modeling and simulation to solve critical development problems.
Previously, Patrick was co-founder of d3 Medicine (acquired by Certara in 2016), helping to build a healthcare company that specialized in providing strategic support for complex development programs. Prior to d3 Medicine, Patrick was U.S. Clinical Pharmacology Lead at Roche for more than 5 years, where he worked in various roles of increasing responsibility in clinical pharmacology and translational medicine. He has served as an Associate Professor at the University at Buffalo School of Pharmacy and Roswell Park Cancer Institute in Buffalo, NY. Patrick has published more than 125 peer-reviewed articles in journals, including the New England Journal of Medicine and Lancet. He received his PharmD at the University of California, San Francisco and completed his clinical residency at Duke University Medical Center.
Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing. She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).
Rik’s key interests are in the integration of model-based components with overall clinical pharmacology and clinical development deliverables throughout the development trajectory. He enjoys combining his analytical skills and creativity in designing efficient drug development strategies that address the right questions at the right time.