With Project Optimus, Success Favors the Prepared
Article: Applied Clinical Trials, May 2, 2022 Oncology drug developers must start asking questions in preparation of FDA
Certara's Better Drug Discovery and Development Process
The drug discovery and development process is long and expensive with more failures than successes. At Certara, we anticipate and address your critical drug discovery and development risks and decisions using biosimulation, technology and services.
In 2021, more than 2,000 customers worldwide chose Certara as their trusted partner for our gold-standard biosimulation software and technology-driven services. We support confident decision-making throughout the entire biopharma R&D process to reduce cycle times, lower costs and improve outcomes for patients.
Additionally, 17 global regulatory agencies have adopted our Phoenix™ PK/PD, Pinnacle 21 and/or Simcyp™ PBPK Simulator software, including the US FDA, Japan's PMDA and China's NMPA.
We are proud to say that our customers, who use our biosimulation software and services, have received 90% of all new drug approvals by the FDA since 2014.
How we help our clients
Simcyp PBPK Simulator
- Determine first-in-human dosing
- Optimize clinical study design
- Evaluate new drug formulations
- Predict drug-drug interactions
Phoenix WinNonlin
- PK/PD analysis
- Noncompartmental analysis (NCA)
- Toxicokinetics.
Integrated Drug Development
- Drug development & regulatory strategy
- Nonclinical development
- Clinical pharmacology and pharmacometrics
Regulatory and Access
- Regulatory writing
- Regulatory operations
- Real-world data solutions
- Market access
Latest from Certara
Get Support for Project Optimus
NEW! Optimus Fitness & Gap Analysis Solutions
Pinnacle 21 - New Release
Check out new capabilities
Simcyp Simulator
Video Demo
Assessing Drug Safety
Blog
Certara Earns 2022 Great Place to Work Certification™
Announcement
Simcyp Wins WCOP 2022 Poster Visualization Award
Poster
PBPK Modeling of Antibody-Drug Conjugates – Concept and Application
On Demand Webinar
Join our team
- Collaborate with leading experts
- Work on a wide range of drug programs
- Enjoy flexibility, competitive benefits, and a culture of passion and fun