Modeling and Simulation Archives

Case Study

Accelerating Oncology Drug FDA Submission with Project Management Services

Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…

Certara2025年7月2日

Blog

5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address

2025年6月30日 Drug development is increasingly defined by its complexity. Teams must navigate rising…

Certara2025年6月30日

Case Study

How Model-informed drug development rescue projects from a risky situation

Discover how Certara’s integrated approach to model-informed drug development helps clients navigate regulatory challenges, achieve…

Certara2025年6月26日

Publication

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…

Danielle Pillsbury2025年6月19日

Webinar

From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara

Certara2025年6月18日

Blog

Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance

With the release of the draft ICH M15 guidance, MIDD is no longer optional -…

Certara2025年6月11日

Publication

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…

Certara2025年6月8日

On-Demand Webinar

Evolving Regulatory Landscape for Model Informed Drug Development (MIDD): Impact of the Draft ICH M15 Guidance

SVP, PBPK Consultancy Services, Certara SVP, Quantitative Science Services, Certara Sr. Director, Clinical Pharmacology, Certara…

Certara2025年5月23日

Blog

CERTAINTY 2025: The power of Model-Informed Drug Development

We cover the key takeaways from CERTAINTY 2025, including the power of Model-Informed Drug Development…

Certara2025年5月16日

Webinar

Explore First: How a Stepwise Approach to QTc Studies Reduces Time, Cost, and Regulatory Risk

Certara2025年5月5日

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モデリング＆シミュレーション

Accelerating Oncology Drug FDA Submission with Project Management Services

5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address

How Model-informed drug development rescue projects from a risky situation

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara

Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

Evolving Regulatory Landscape for Model Informed Drug Development (MIDD): Impact of the Draft ICH M15 Guidance

CERTAINTY 2025: The power of Model-Informed Drug Development

Explore First: How a Stepwise Approach to QTc Studies Reduces Time, Cost, and Regulatory Risk

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