Modern drug development is a team sport
Our drug development teams have collaborated with our partners on well over 250 programs, across all stages of development and in every therapeutic area from oncology to rare diseases.
Acting as your dedicated stewards, our best-practice, quantitative 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 ompromises more than 50% of a drug label.
Drug Development and Regulatory Strategy
With our proven quantitative 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.
Clinical Pharmacology
Our clinical pharmacology expertise is critical for optimizing safety and efficacy in drug development. Clinical pharmacology ompromises more than 50% of a drug label.
Drug Development and Regulatory Strategy
With our proven quantitative 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.
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.
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.
Dr. Patrick F. Smith is President, Certara Drug Development Solutions, 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.
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.
Mr. Schemick has served as Senior Vice President, Corporate Operations and Integration since April 1, 2023 and focuses on building operational excellence as Certara continues to grow. From August 2014 through March 2023, he served as Chief Financial Officer. Mr. Schemick brings 19 years of financial management experience to the company in a wide range of industries, including software and consulting organizations. Before Certara, Schemick served as Vice President of Financial Planning and Analysis for Haights Cross Communications, a holding company for education and media investments, playing a key role in business transformation, strategy, and financial operations on behalf of private equity investors. Schemick also held Chief Financial Officer roles for two divisions of Kaplan Inc, a leading education company, and has significant experience in both public and private equity backed enterprises. Schemick started his career at Arthur Andersen after graduating with an MBA in accounting from Rutgers University. In addition, he has earned the titles of CPA and CTP.
Dr. Patrick F. Smith is President, Certara Drug Development Solutions, 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.
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.
Mr. Schemick has served as Senior Vice President, Corporate Operations and Integration since April 1, 2023 and focuses on building operational excellence as Certara continues to grow. From August 2014 through March 2023, he served as Chief Financial Officer. Mr. Schemick brings 19 years of financial management experience to the company in a wide range of industries, including software and consulting organizations. Before Certara, Schemick served as Vice President of Financial Planning and Analysis for Haights Cross Communications, a holding company for education and media investments, playing a key role in business transformation, strategy, and financial operations on behalf of private equity investors. Schemick also held Chief Financial Officer roles for two divisions of Kaplan Inc, a leading education company, and has significant experience in both public and private equity backed enterprises. Schemick started his career at Arthur Andersen after graduating with an MBA in accounting from Rutgers University. In addition, he has earned the titles of CPA and CTP.