CDISC Archives

Blog

P21 Enterprise Expands Regulatory Validation Capabilities with Support for the Tobacco Implementation Guide v1.0

Pinnacle 21 supports TIG v1.0, the CDISC Tobacco Implementation Guide for FDA CTP, enabling automated…

Certara2026 年 1 月 30 日

Blog

How to build standardized eCRFs across multiple EDC systems

Discover how to build standardized eCRFs across multiple EDC systems to improve data quality, accelerate…

Certara2025 年 12 月 12 日

Blog

7 key annotated CRF regulatory submission requirements you should know

Discover 7 key aCRF regulatory submission requirements for delivering high-quality annotated CRFs, including real-world examples…

Gilbert Hunter2025 年 12 月 10 日

Blog

阐明 CDISC、SDTM 和 ADaM

Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…

Certara2025 年 10 月 16 日

Blog

关于 SDTM 您需要了解的一切

Find out all you need to know about CDISC SDTM, from the SDTM implementation guide…

Certara2025 年 10 月 16 日

Blog

The SDTM Mapping Process Simplified

2025 年 10 月 15 日 SDTM mapping can be one of the most challenging programming problems in…

Certara2025 年 10 月 15 日

Guide

Top 10 Things to Know About ADNCA for Non-Compartmental Analysis

Learn how to transition from non-standard ADPC datasets to the CDISC ADNCA ADaM standard. Improve…

Certara2025 年 9 月 11 日

Blog

Define.xml 递交的 Do’s 与 Don’ts

Discover the 6 dos and don’ts of creating compliant define.xml files for FDA submission with…

Certara2025 年 6 月 27 日

Blog

Exploring Common CDISC ADaM Conformance Findings

2025 年 3 月 27 日 ADaM data are required by the FDA and PMDA and accepted by…

Certara2025 年 3 月 27 日

Video

Pinnacle 21 – Data standardization and validation for faster analysis and submission

Certara2025 年 3 月 3 日

CDISC

P21 Enterprise Expands Regulatory Validation Capabilities with Support for the Tobacco Implementation Guide v1.0

How to build standardized eCRFs across multiple EDC systems

7 key annotated CRF regulatory submission requirements you should know

阐明 CDISC、SDTM 和 ADaM

关于 SDTM 您需要了解的一切

The SDTM Mapping Process Simplified

Top 10 Things to Know About ADNCA for Non-Compartmental Analysis

Define.xml 递交的 Do’s 与 Don’ts

Exploring Common CDISC ADaM Conformance Findings

Pinnacle 21 – Data standardization and validation for faster analysis and submission

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