Case Study Archives

Case Study

How Certara MIDD Experts Overcame Client Regulatory Challenges

Certara’s Model-Informed Drug Development (MIDD) approach leverages an integrated, quantitative systems methodology to accelerate regulatory…

CertaraApril 8, 2025

Case Study

Standardizing Real World Data in Rare Disease: ATHN’s Journey

Learn how Certara helped ATHN standardize Real World Data for regulatory submissions, advancing rare disease…

CertaraApril 8, 2025

Case Study

Unlocking Success with Phoenix Hosted: Real-World Customer Stories

As part of our Phoenix Hosted webinar, we highlighted three customer success stories showcasing the…

CertaraApril 2, 2025

Case Study

QSP Modeling Optimizes FIH Dose Selection for Multiple Myeloma Therapy

Multiple myeloma, the second most common blood cancer, affects an estimated 160,000 individuals annually worldwide…

CertaraMarch 25, 2025

Case Study

Quantitative systems pharmacology model of mRNA lipid nanoparticle for two programs at the preclinical to clinical transition

This case study features Applied BioMath's* collaboration with Alexion Pharmaceuticals. Alexion Pharmaceuticals, Inc. is a…

CertaraMarch 25, 2025

Case Study

Helping Sponsor Meet EMA Policy 0070 Requirements

The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for…

CertaraJanuary 7, 2025

Case Study

Streamlining the Preparation of 1-Year and 2-Year PSURs

We explore how we helped one client deliver a last-minute addition to a Periodic Safety…

CertaraDecember 18, 2024

Case Study

Delivering High-Quality, Timely Responses to EMA Safety Queries

A pharmaceutical company approached us for support with eight safety-related queries from the European Medicines…

CertaraDecember 12, 2024

Case Study

CMC Writing Support Helps Client Lift Clinical Hold

In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the…

CertaraDecember 10, 2024

Case Study

Enhancing Pharmacokinetics Workflows at Charles River

PreclinicalPhoenix™ Integral Data Repository Charles River, a global leader in drug development, sought to improve…

CertaraNovember 13, 2024

Case Study

How Certara MIDD Experts Overcame Client Regulatory Challenges

Standardizing Real World Data in Rare Disease: ATHN’s Journey

Unlocking Success with Phoenix Hosted: Real-World Customer Stories

QSP Modeling Optimizes FIH Dose Selection for Multiple Myeloma Therapy

Quantitative systems pharmacology model of mRNA lipid nanoparticle for two programs at the preclinical to clinical transition

Helping Sponsor Meet EMA Policy 0070 Requirements

Streamlining the Preparation of 1-Year and 2-Year PSURs

Delivering High-Quality, Timely Responses to EMA Safety Queries

CMC Writing Support Helps Client Lift Clinical Hold

Enhancing Pharmacokinetics Workflows at Charles River

Newsletter sign up

Quick links

Solutions

Contact