3 Things You Should Know About ADaM Standards
Learn the key aspects of ADaM standards, including the difference between SDTM and ADaM and…
CertaraApril 27, 2026
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…
CertaraJanuary 30, 2026
How to build standardized eCRFs across multiple EDC systems
Discover how to build standardized eCRFs across multiple EDC systems to improve data quality, accelerate…
CertaraDecember 12, 2025
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 HunterDecember 10, 2025
Demystifying CDISC, SDTM, and ADaM
Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…
CertaraOctober 16, 2025
Everything You Need to Know About SDTM
Find out all you need to know about CDISC SDTM, from the SDTM implementation guide…
CertaraOctober 16, 2025
The SDTM Mapping Process Simplified
October 15, 2025 SDTM mapping can be one of the most challenging programming problems in…
CertaraOctober 15, 2025
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…
CertaraSeptember 11, 2025
The Do’s and Don’ts of Define.xml
Discover the 6 dos and don’ts of creating compliant define.xml files for FDA submission with…
CertaraJune 27, 2025
Exploring Common CDISC ADaM Conformance Findings
March 27, 2025 ADaM data are required by the FDA and PMDA and accepted by…
CertaraMarch 27, 2025
