Case Study

Securing Pimicotinib Approval: How Abbisko Therapeutics Successfully Completed its NMPA and FDA Submissions with Pinnacle 21 Enterprise

Learn how Abbisko Therapeutics improved regulatory readiness and accelerated its path to submission readiness, securing…

CertaraSeptember 30, 2026

Webinar

From Excel to Enterprise: A Sponsor’s Journey to Modern Clinical Metadata Management

Trevor MankusSeptember 23, 2026

Fact Sheet

External Data Accelerator: Your standards-first team and technology for conformant vendor data

Our tech-enabled team embeds standards and validation from day one, so your data lands clean,…

CertaraSeptember 15, 2026

Guide

A Best Practice Guide to Validation in Clinical Data Management

Learn best practices for software validation in research settings with this guide to validation in…

Danielle PillsburySeptember 2, 2026

Fact Sheet

Go beyond basic validation: Achieve submission-ready datasets with Pinnacle 21 Enterprise

Explore how Pinnacle 21 Enterprise simplifies dataset validation, enhances compliance, and prepares you for regulatory…

CertaraJuly 30, 2026

On-Demand Webinar

Change without chaos: Orchestrating CDISC & terminology updates

Watch our webinar on managing CDISC standard convergence, controlled terminology updates & change management with…

Rajesh SahaJuly 29, 2026

On-Demand Webinar

Unlock the Power of SEND Data: From FDA Compliance to Global Regulatory Readiness for Preclinical Data [Korean Webinar with Biotoxtech]

CertaraJuly 22, 2026

Blog

Cracking the code on NCA: How Pinnacle 21 helps de-risk PK analyses

Learn how Pinnacle 21, strong data foundations, and better workflows reduce risk in PK noncompartmental…

Wendy YoungJuly 7, 2026

Blog

Why ask your CRO to use Pinnacle 21 Enterprise?

Why sponsors should require CROs to use Pinnacle 21 Enterprise - reduce compliance risk &…

CertaraMay 22, 2026

Blog

Everything you need to know about CRFs in clinical trials

Read about the basics of CRFs and eCRF design, why annotated CRFs should be standardized…

Gilbert HunterMay 22, 2026

Certara Products – Pinnacle 21

Securing Pimicotinib Approval: How Abbisko Therapeutics Successfully Completed its NMPA and FDA Submissions with Pinnacle 21 Enterprise

From Excel to Enterprise: A Sponsor’s Journey to Modern Clinical Metadata Management

External Data Accelerator: Your standards-first team and technology for conformant vendor data

A Best Practice Guide to Validation in Clinical Data Management

Go beyond basic validation: Achieve submission-ready datasets with Pinnacle 21 Enterprise

Change without chaos: Orchestrating CDISC & terminology updates

Unlock the Power of SEND Data: From FDA Compliance to Global Regulatory Readiness for Preclinical Data [Korean Webinar with Biotoxtech]

Cracking the code on NCA: How Pinnacle 21 helps de-risk PK analyses

Why ask your CRO to use Pinnacle 21 Enterprise?

Everything you need to know about CRFs in clinical trials

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