Certara B2B Case Studies & Customer Successes

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Case Studies

Showing 58 Certara Customer Success Stories

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

Alexion Pharmaceuticals

Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy

Alkermes

Standardizing Real World Data in Rare Disease ATHN’s Journey

American Thrombosis and Hemostasis Network (ATHN)

Christine Gerber

Senior Project Manager

Arvinas Selects Certara’s D360 to Advance Speed and Efficiency of Discovery Research

Arvinas

Keith Hornberger

Director of Chemistry

Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials

Asciminib

Biogen Transforms Study Metadata Management with Certara’s Metadata Repository

Biogen

Todd Bazin

Head, Data Standards

Medicines that matter Biohaven’s Nurtec™ drug development journey

Biohaven Pharmaceuticals

Richard Bertz

Senior Vice President, Clinical Pharmacology & Pharmacometrics

How A Biotech Startup Company Increased Flexibility and Efficiency by Switching to Phoenix Hosted

Biotech Startup Company

Using Modeling to Demonstrate the Kinetics of Liso-Cel Transgene

Bristol Myers Squibb

Systems Modeling Delivers Efficiencies and Savings in Clinical Development

CDR-Life

Melissa Vrohlings

Translational Science Leader

Enhancing Pharmacokinetics Workflows at Charles River

Charles River

Jocelyn Webb

Charles River

Adopting CDISC Standards Our Journey With CDISC

Clinical Data Interchange Standards Consortium (CDISC)

How one university overcame practical and cultural challenges to implement CDISC compliance

Clinical Data Interchange Standards Consortium (CDISC)

Ryan Miller

Business Development Manager

Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

Dizal Pharma

Kan Chen

Vice President of Clinical Pharmacology

Helping Sponsor Meet EMA Policy 0070 Requirements

European Medicines Agency

Joint Clinical Assessment (JCA) And Potential Consequences For The Evaluation Of Gene Therapies

Galderma

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

Galderma

Nathalie Wagner

Senior Clinical PK Manager

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

Genentech

Transforming Non-clinical Drug Development with SEND Explorer

Genmab

Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey

Global Biopharmaceutical Company

Early Value Assessment in Gene Therapy Clinical Trial Design

Global Biotechnology Company

Accelerating a drug launch with value communication technology and an integrated workflow

Global Pharmaceutical Company

Complex patient profile and narrative template needs

Global Pharmaceutical Company

Enabling Personalized Therapy with PBPK Modeling for Pediatric Epilepsy

GRIN Therapeutics

Pierandrea Muglia

Founder

Enhancing HEOR Global Knowledge Sharing

Health Economics and Outcomes Research (HEOR)

QSP Modeling Optimizes FIH Dose Selection for Multiple Myeloma Therapy

Ichnos Glenmark Innovation

Mario Perro

Head of Biologics Research

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Ionis Pharmaceuticals

Optimizing Dosing and Regulatory Outcomes in Duchenne Muscular Dystrophy (DMD) Drug Development

Italfarmaco

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

KalVista Pharmaceuticals

Large Biotech Streamlines Investigator’s Brochures with Certara’s Project Management Expertise

Large Biotech Company

Optimizing Clinical Development: Saving Time and Costs

Large Biotech Company

Streamlining Biotech Data Compliance and Management with Certara’s Phoenix Hosted

Large Biotechnological Company

Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints

Large Pharmaceutical Company

CMC Writing Support Helps Client Lift Clinical Hold

Large Pharmaceutical Company

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

Leading Biopharmaceutical Company

Delivering High-Quality, Timely Responses to EMA Safety Queries

Leading Pharmaceutical Company

Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints

Leading Pharmaceutical Company

How Chinese CRO, Zhejiang Longcharm Biomedical Technology Uses Pinnacle 21 Enterprise to Optimize Sponsors’ Non-clinical and Clinical Regulatory Affairs

Longcharm Biomedicine Technology

Liming Fang

Deputy General Manager

MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

MacroGenics

Daner Li

Director, Clinical Programming

Medtronic Demonstrating the economic value of minimally invasive spinal surgery on the iPad

Medtronic

Carolin Miltenburger

Senior Director, Global Health Economics & Reimbursement

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Merck & Co.

Accelerated ADC Approval Through Expert Modeling and Data Rescue

Mid-Size Biopharmaceutical Company

Delivering DSUR Excellence for Multinational Biopharma

Multinational Biopharma Company

Dose Optimization Using Population PK for an Orphan Drug

Nobelpharma

Using customer engagement technology to create value communication tools for ABILIFY MAINTENA® (aripiprazole)

Otsuka

Heidi Waters

Director of Outcomes Management

DDI Regulatory Poster Child using the Simcyp Simulator Ibrutinib (Imbruvica®)

Pharmacylics

Prelude Therapeutics reduces their quality control (QC) process for regulatory submissions from hours to minutes with Certara’s GlobalSubmit eCTD Software

Prelude Therapeutics

Jessica Pung

Associate Director of Regulatory Operations

Defining path-to-market strategy through a data-driven and scientific approach

Private Gene Therapy Company

Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease

RedHill Biopharma

Agent-Based Model Predicts Impact of Monoclonal Antibody Treatment, Prophylaxis & Vaccines on Viral Transmission during Pandemic

Regeneron Pharmaceuticals

Transforming Health Economics Communication for a Global Biopharmaceutical Company in Colombia

Sanofi

Unlocking Success with Phoenix Hosted Real-World Customer Stories

Small Biopharmaceutical Company

Organizing Complex Virology Datasets into FDA-Ready Format using SAS Programming

Small Biotech Firm

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

Small Biotechnology Company

Model-Informed Confidence in Oncology Dose Selection

Sutro Biopharma

Anne Borgman

Chief Marketing Officer

How a top 10 pharma fought the rising tide of non-EDC data

Top 10 Global Biopharma Company

How Certara and TrialAssure Partner to Deliver Faster, Compliant Anonymization for Global Sponsors

TrialAssure

Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program

Xentria

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