Oncology/Hematology Archives

Blog

Using M&S to Evaluate Oncology Drug Dosing

Learn how modeling & simulation improves oncology drug dosing, optimizing safety, efficacy, and personalized treatment…

CertaraNovember 14, 2025

Case Study

Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Discover how MacroGenics optimized validation in their clinical data management with our centralized, collaborative Pinnacle…

CertaraNovember 12, 2025

Case Study

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…

Danielle PillsburyNovember 12, 2025

Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

CertaraNovember 10, 2025

Press Coverage Video

Preparing for the Operational Burden of OS Requirements in Oncology Trials

Ananth Kadambi outlines how clinical operations teams can plan for FDA’s OS requirements—enhancing patient tracking…

CertaraSeptember 26, 2025

Press Coverage Video

How RWE and Predictive Modeling Support OS-Focused Trial Designs

Discover how real-world evidence and predictive modeling strengthen OS-focused trial designs in oncology, improving efficiency…

CertaraSeptember 25, 2025

Press Coverage Video

Using Model-Informed Drug Development to Support OS Endpoints

Ananth Kadambi shares how model-informed drug development helps sponsors predict efficacy and align shorter oncology…

CertaraSeptember 24, 2025

Press Coverage Video

How FDA’s Focus on Overall Survival Redefines Trial Success

Ananth Kadambi explains how FDA’s emphasis on overall survival reshapes oncology drug trial success metrics…

CertaraSeptember 23, 2025

Press Coverage Video

Operational Challenges of Using Overall Survival as a Primary Endpoint

In this ACT interview, Certara’s Ananth Kadambi discusses the operational hurdles sponsors face as FDA…

CertaraSeptember 22, 2025

Case Study

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

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

CertaraJuly 2, 2025

Oncology/Hematology

Using M&S to Evaluate Oncology Drug Dosing

Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Preparing for the Operational Burden of OS Requirements in Oncology Trials

How RWE and Predictive Modeling Support OS-Focused Trial Designs

Using Model-Informed Drug Development to Support OS Endpoints

How FDA’s Focus on Overall Survival Redefines Trial Success

Operational Challenges of Using Overall Survival as a Primary Endpoint

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

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