Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3
On November 29th 2021, CDISC released updated versions of SDTM and ADaM, including standardized structures…
Danielle Pillsbury2021年12月16日
Industry Metrics for CDISC Controlled Terminology
Sergiy Sirichenko summarizes industry metrics across many studies and sponsors to produce an overall picture…
Certara2021年11月17日
New Pinnacle 21 Community Validation Engine: FDA (1907.2)
In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing…
Certara2020年9月13日
Exploring Common CDISC ADaM Dataset Conformance Findings
What you need to know when validating your CDISC ADAM datasets During the regulatory review…
Danielle Pillsbury2020年9月3日
The supplementary domain in SDTM: good, bad and ugly
All you need to know about the supplementary domain in SDTM The supplementary domain in…
Danielle Pillsbury2020年7月2日
Data Validation in Clinical Research: Confusing Rules Explained
What should you do when faced with confusing findings during data validation in clinical research? …
Danielle Pillsbury2020年4月30日
Common Questions about Define-XML and the Stylesheet
In this blog, we answer common questions about Define-XML and the Stylesheet, including all you…
Certara2019年8月22日
Introducing P21 Community 3.0
2019年5月7日 We are thrilled to announce that P21 Community 3.0 is available for immediate…
Certara2019年5月7日
New Pinnacle 21 Enterprise 4.0 Eases Concern about PMDA Submissions
2019年4月2日 Released March 31, the new P21 Enterprise 4.0 provides more options for…
Certara2019年4月2日
What’s New in Enterprise 3.4 Q&A
Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded…
Certara2018年5月17日
