Data Standards Archives

Case Study

Biogen Transforms Study Metadata Management with Certara’s Metadata Repository

Discover how study metadata management, paired with CDISC standards, transformed Biogen’s clinical trial processes and…

CertaraSeptember 5, 2025

Press Release

Certara Launches Pinnacle 21® Enterprise Plus to Deliver Regulatory Submissions Faster

Pinnacle 21® Enterprise Plus delivers a 50% reduction in time spent drafting mapping specifications, according…

CertaraSeptember 4, 2025

Blog

Accelerate your SDTM Mapping with Pinnacle 21 Enterprise Plus

Streamline your SDTM mapping with Pinnacle 21 Enterprise. Discover how innovation and efficiency enhance data…

CertaraAugust 13, 2025

Press Coverage

Increasing Productivity In Pharma R&D Starts With Data

This article discusses the growing volume of raw data collected during clinical research, and how…

CertaraJune 25, 2025

On-Demand Webinar

Modernizing NCA Workflows: The Power of ADNCA for Regulatory-Ready Pharmacokinetic Analysis

CertaraJune 11, 2025

Blog

Using SDTM Data to Produce Patient Narratives

In this blog, we look at how medical writers can use SDTM data produced by…

CertaraApril 15, 2025

Blog

Exploring Common CDISC ADaM Conformance Findings

March 27, 2025 ADaM data are required by the FDA and PMDA and accepted by…

CertaraMarch 27, 2025

Blog

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

March 19, 2025 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…

CertaraMarch 19, 2025

Blog

Rolling NDA and BLA Submissions: Accelerate Your Review Timeline

We look at the growing regulatory trend of rolling NDA and BLA submissions to help…

CertaraFebruary 3, 2025

On-Demand Webinar

GlobalSubmit eCTD 4.0 Webinars

The world of electronic regulatory submissions is about to change with the introduction of eCTD…

CertaraDecember 3, 2024

Data Standards

Biogen Transforms Study Metadata Management with Certara’s Metadata Repository

Certara Launches Pinnacle 21® Enterprise Plus to Deliver Regulatory Submissions Faster

Accelerate your SDTM Mapping with Pinnacle 21 Enterprise Plus

Increasing Productivity In Pharma R&D Starts With Data

Modernizing NCA Workflows: The Power of ADNCA for Regulatory-Ready Pharmacokinetic Analysis

Using SDTM Data to Produce Patient Narratives

Exploring Common CDISC ADaM Conformance Findings

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

Rolling NDA and BLA Submissions: Accelerate Your Review Timeline

GlobalSubmit eCTD 4.0 Webinars

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