The top 3 reasons why global pharmaceutical companies, biotechnology startups, and venture capital and private equity firms alike choose Certara:
1. Clients and partners choose us for 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.
2. 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. Building relationships between our experts and your team is our focus. This is the reason our top 30 customers by revenue in 2022 have been with us for more than ten years on average.
3. Our proven track record speaks for itself. We have a library of case studies on our successful collaborations in oncology, rare diseases, infectious diseases, neurodegenerative diseases, and more. Since 2014, customers who use our biosimulation software and technology-driven services have received 90% of all new drug approvals by the U.S. Food and Drug Administration (“FDA”).
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.
Drug Development Stewardship
Our R&D Program Leaders worldwide partner with clients to develop key decision criteria and help facilitate decision-making throughout your drug development program.
Program Management
We provide skilled management outsourcing support for your function or department. Our team offers end-to-end project management expertise and excellence in both early and late-stage drug development programs.
Clinical Science
Certara’s clinical scientists provide clinical oversight from beginning to end and design your clinical development program to achieve your goals.
Clinical Pharmacology Study Execution Team
The expertise and experience to set up your clinical pharmacology program for success. We can help ensure that your CRO does everything correctly, efficiently, and not more than is needed.
Early Development/Investigational New Drug (IND) Enabling Services
Get peace of mind now. Our clients benefit from complete analysis of safety issues to prevent timeline delays and apply unique study designs to move faster into the proof-of-concept (POC) clinical studies.
Since 2014, our customers have received over 90% of new drug and biologic approvals by the FDA. These FDA approvals span across several designations and therapeutic areas, including oncology, infectious disease, hematology, pulmonology, cardiology, dermatology, diabetes, neurology, gastroenterology, psychiatry, bone, migraine, sleep disorders and more. View the case studies below to see for yourself.
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.