Clinical Trials Archives

Case Study

Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

Find out how Certara helped a small biotech achieve on-time IND and CTA submissions with…

CertaraAugust 18, 2025

Conference

BioTechX US 2025

– – Booth

Simona ColucciAugust 15, 2025

Publication

Population Pharmacokinetics for Belantamab Mafodotin Monotherapy and Combination Therapies in Patients with Relapsed/Refractory Multiple Myeloma

Explore comprehensive population pharmacokinetic analyses of belantamab mafodotin, evaluating both monotherapy and combination regimens in…

CertaraAugust 13, 2025

Publication

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Explore updated results from the Phase 3 TROPiCS-02 trial of Sacituzumab Govitecan in advanced HR+/HER2–…

CertaraAugust 13, 2025

Blog

Replacing Traditional TQT Studies with Model-Based Concentration-QTc (C-QTc) Analysis for Cardiovascular Safety in Drug Development

Learn how our experts use concentration-QTc (C-QTc) analysis to replace costly TQT studies, streamline QT…

CertaraAugust 6, 2025

On-Demand Webinar

De-risking DDI Management during Clinical Trials: Introducing DIDB’s Concomitant Meds Navigator

Watch the on-demand presentation covering how the DIDB® Concomitant Meds Navigator empowers clinical development teams…

CertaraAugust 5, 2025

Blog

ADNCA Explained: The Next Generation of Non-Compartmental Analysis and the Top Questions Answered

ADNCA is transforming non-compartmental analysis by standardizing workflows, enhancing regulatory confidence, and enabling scalable automation.…

CertaraJuly 23, 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

Press Coverage

The Medicine Maker: The Biosimulation Generation

The article, The Biosimulation Generation, explores the transformative potential of biosimulation in pharmaceutical R&D as…

Danielle PillsburyJuly 1, 2025

Blog

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

June 30, 2025 Drug development is increasingly defined by its complexity. Teams must navigate rising…

CertaraJune 30, 2025

Clinical Trials

Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

BioTechX US 2025

Population Pharmacokinetics for Belantamab Mafodotin Monotherapy and Combination Therapies in Patients with Relapsed/Refractory Multiple Myeloma

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Replacing Traditional TQT Studies with Model-Based Concentration-QTc (C-QTc) Analysis for Cardiovascular Safety in Drug Development

De-risking DDI Management during Clinical Trials: Introducing DIDB’s Concomitant Meds Navigator

ADNCA Explained: The Next Generation of Non-Compartmental Analysis and the Top Questions Answered

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

The Medicine Maker: The Biosimulation Generation

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

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