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
