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

Alexion Pharmaceuticals advances mRNA lipid nanoparticle development with Certara QSP modeling

Alexion Pharmaceuticals

Alkermes predicts hepatic impairment and DDI risk with Certara's Simcyp PBPK modeling

Alkermes

ATHN achieves FDA-ready real-world data standardization with Certara

American Thrombosis and Hemostasis Network (ATHN)

Christine Gerber

Senior Project Manager

Arvinas accelerates discovery research with Certara’s D360

Arvinas

Keith Hornberger

Director of Chemistry

Novartis streamlines asciminib NDA submission with Certara's PBPK modeling

Asciminib

Biogen streamlines study metadata management with Certara Pinnacle 21

Biogen

Todd Bazin

Head, Data Standards

Biohaven Pharmaceuticals accelerates Nurtec approval and migraine care with Certara clinical pharmacology and PBPK modeling

Biohaven Pharmaceuticals

Richard Bertz

Senior Vice President, Clinical Pharmacology & Pharmacometrics

a biotech startup company achieves greater flexibility and efficiency with Certara Phoenix Cloud

Biotech Startup Company

Bristol Myers Squibb clarifies liso-cel kinetics with Certara modeling

Bristol Myers Squibb

CDR-Life achieves cost-effective clinical development with Certara's QSP modeling solutions

CDR-Life

Melissa Vrohlings

Translational Science Leader

Charles River streamlines global PK workflows with Certara

Charles River

Jocelyn Webb

Charles River

Adopting CDISC Standards Our Journey With CDISC

Clinical Data Interchange Standards Consortium (CDISC)

CDISC enables a university to achieve faster, compliant study builds with Certara Pinnacle 21

Clinical Data Interchange Standards Consortium (CDISC)

Ryan Miller

Business Development Manager

Dizal Pharma Achieves FDA Approval for Sunvozertinib with Certara

Dizal Pharma

Kan Chen

Vice President of Clinical Pharmacology

European Medicines Agency achieves compliant clinical data disclosure with Certara

European Medicines Agency

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

Galderma

Galderma achieves FDA approval for AKLIEF with Certara's Simcyp PBPK Simulator

Galderma

Nathalie Wagner

Senior Clinical PK Manager

Genentech informs Polivy DDI labeling without clinical trials with Certara's Simcyp PBPK Simulator

Genentech

Genmab accelerates non-clinical drug development with Certara SEND Explorer

Genmab

a global biopharmaceutical company accelerates clinical trial design with Certara Pinnacle 21

Global Biopharmaceutical Company

a global biotechnology company improves gene therapy trial design with Certara Evidence and Access

Global Biotechnology Company

a global pharmaceutical company accelerates drug launch value communication with Certara BaseCase

Global Pharmaceutical Company

a global pharmaceutical company streamlines complex patient profiles and narrative templates with Certara

Global Pharmaceutical Company

GRIN Therapeutics achieves personalized pediatric epilepsy dosing with Certara PBPK modeling

GRIN Therapeutics

Pierandrea Muglia

Founder

Enhancing HEOR Global Knowledge Sharing

Health Economics and Outcomes Research (HEOR)

Ichnos Glenmark Innovation optimizes first-in-human dosing with Certara QSP modeling

Ichnos Glenmark Innovation

Mario Perro

Head of Biologics Research

Ionis Pharmaceuticals accelerates Donidalorsen BLA submission with Certara exposure-response modeling

Ionis Pharmaceuticals

Italfarmaco achieves FDA approval for Givinostat with Certara’s pharmacometric and regulatory support

Italfarmaco

KalVista Pharmaceuticals achieves FDA NDA acceptance for a novel HAE treatment with Certara

KalVista Pharmaceuticals

a large biotech streamlines Investigator’s Brochures with Certara project management

Large Biotech Company

a small clinical-stage biotech accelerates clinical development and cuts costs with Certara QSP modeling

Large Biotech Company

a biotechnological company streamlines data compliance and management with Certara Phoenix Cloud

Large Biotechnological Company

Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints

Large Pharmaceutical Company

a large pharmaceutical company lifts clinical hold with Certara’s CMC writing support

Large Pharmaceutical Company

a leading biopharmaceutical company accelerates FDA RTOR submission with Certara project management services

Leading Biopharmaceutical Company

a pharmaceutical company delivers timely EMA safety responses with Certara

Leading Pharmaceutical Company

a leading pharmaceutical company validates surrogate endpoints for NSCLC with Certara CODEx

Leading Pharmaceutical Company

Longcharm Biomedicine Technology streamlines clinical regulatory review with Certara Pinnacle 21 Enterprise

Longcharm Biomedicine Technology

Liming Fang

Deputy General Manager

MacroGenics achieves streamlined clinical data validation with Certara’s Pinnacle 21 Enterprise

MacroGenics

Daner Li

Director, Clinical Programming

Medtronic demonstrates the economic value of minimally invasive spinal surgery with Certara BaseCase

Medtronic

Carolin Miltenburger

Senior Director, Global Health Economics & Reimbursement

Merck & Co. advances pediatric oncology dosing with Certara ADC modeling

Merck & Co.

a mid-size biopharmaceutical company achieves rapid ADC approval for two indications with Certara modeling and data rescue

Mid-Size Biopharmaceutical Company

Delivering DSUR Excellence for Multinational Biopharma

Multinational Biopharma Company

Nobelpharma achieves orphan drug dose optimization with Certara

Nobelpharma

Otsuka achieves faster, lower-cost value communication tool development with Certara BaseCase

Otsuka

Heidi Waters

Director of Outcomes Management

Pharmacyclics achieves FDA-recognized DDI dosing guidance with Certara's Simcyp Simulator

Pharmacylics

Prelude Therapeutics reduces QC submission review from hours to minutes with Certara GlobalSubmit eCTD Software

Prelude Therapeutics

Jessica Pung

Associate Director of Regulatory Operations

a private gene therapy company defines its path-to-market strategy with Certara

Private Gene Therapy Company

RedHill Biopharma accelerates Phase 3 readiness for RHB-204 with Certara translational pharmacology consulting

RedHill Biopharma

Regeneron Pharmaceuticals predicts COVID-19 treatment impact with Certara's agent-based modeling

Regeneron Pharmaceuticals

Sanofi achieves clearer health economics communication in Colombia with Certara BaseCase

Sanofi

a small biopharmaceutical company achieves stable, high-performance modeling with Certara Phoenix Cloud

Small Biopharmaceutical Company

a small biotech firm achieves FDA-ready virology dataset organization with Certara SAS programming

Small Biotech Firm

a small biotechnology company achieves on-time IND and CTA submissions with Certara

Small Biotechnology Company

Sutro Biopharma gains confidence in pediatric AML dose selection with Certara QSP modeling

Sutro Biopharma

Anne Borgman

Chief Marketing Officer

a top 10 global biopharma company streamlines non-EDC data management with Certara Pinnacle 21 Data Exchange

Top 10 Global Biopharma Company

TrialAssure delivers faster, compliant clinical document anonymization with Certara

TrialAssure

Xentria advances sarcoidosis drug development with Certara's PK modeling and medical writing expertise

Xentria

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