Successful early clinical trials depend on strategic design, informed planning, and a clear clinical development roadmap. Certara helps you optimize First-in-Human (FIH) study design, clinical trial protocols, and development plans to minimize risk and improve decision-making. By leveraging our expertise in profiling drug behavior, anticipating variability, and refining trial design, we empower you to enhance success rates and accelerate your path to approval.
Move your program forward with confidence
Early clinical
Build your evidence and insights
Explore dosing options
Leverage biosimulation to predict responses, analyze data, and refine strategies to design more efficient early-phase trials.
Robust data insights
Transform complex data into actionable insights through advanced pharmacometric modeling and expert consulting services.
Regulatory readiness
Execute your comprehensive clinical development plan, streamline data validation, and prepare regulatory-ready submissions.
Your trusted guide to early clinical success
Certara’s expertise and world-class biosimulation capabilities optimize First-in-Human (FIH) studies and clinical development plans.
- Refine Dosing & Trial Design with industry-leading platforms like Simcyp Simulator and Phoenix PK/PD to enhance decision-making.
- Strengthen Regulatory Submissions using validated standards for trial design, data analysis, and compliance.
- Gain Expert Insights to confirm dosing strategies, assess drug interactions, and predict outcomes in special populations.
Early clinical products
Early clinical services
Early clinical resources
View allLooking at the solutions [Certara] are implementing to increase the speed of drug development, is something that is very exciting. Certara is doing some very cool things with AI, especially, that is going to make that space the next evolution of drug development.
Jocelyn Webb
Charles River Laboratories
Partner with Certara for early clinical success
Gain a competitive edge with Certara’s world class biosimulation platforms and expert services tailored to your early clinical challenges.
Streamline your clinical trial design with trusted PK/PD data analysis and simulation tools like Simcyp and Phoenix.
Optimize dosing strategies for special populations with cutting-edge biosimulation expertise.
Accelerate regulatory submission readiness with platforms trusted by global agencies like Pinnacle 21.
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Explore our solutions across drug development
Regulatory solutions
Streamline your regulatory journey with Certara’s tailored strategies, AI-driven document automation, and expert compliance support.
Discovery Solutions
Drive discovery success using Certara’s advanced modeling, data integration, and simulation tools to refine candidates and streamline decision-making.
Preclinical solutions
Harness biosimulation and predictive modeling to streamline preclinical development and increase IND submission success.
Late clinical solutions
Streamline trial data standardization and validation, regulatory compliance, and submission preparation, ensuring precision, speed, and global confidence.
Commercial and Market Access solutions
Maximize your therapy’s success with Certara’s advanced analytics and real-world data integration, delivering persuasive value propositions, optimizing pricing, and ensuring payer ready strategies.
