New PMDA Validation Rules 3.0 Explained
In this blog, we explore what you need to know about the update to the…
Certara2022年3月2日
P21 Releases New PMDA Validation Engine
New PMDA Engine Pinnacle 21 is happy to announce the latest Validation Engine for submissions…
Certara2021年12月20日
Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3
On November 29th 2021, CDISC released updated versions of SDTM and ADaM, including standardized structures…
Certara2021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
Certara Completes Acquisition of Pinnacle 21
PRINCETON, N.J., Oct. 04, 2021 - Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in biosimulation,…
Simona Colucci2021年10月4日
Preparing Vaccine Studies for Regulatory Submissions
In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…
Certara2021年9月10日
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?
TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical…
Certara2021年9月10日
Controlled Terminology Best Practices
Simplify Controlled Terminology with expert insights from Sarah Angelo. Overcome challenges, ensure compliance, and improve…
Certara2021年3月3日
Formatting Annotated Case Report Forms (aCRFs): Not Submitted Annotations and SDRG
Simplify aCRFs with insights on “Not Submitted” annotations, reviewer’s guide tips, and define origin column…
Certara2020年11月13日
Preparing CDISC Submissions for China’s NMPA
China’s NMPA now accepts CDISC submissions. To support this initiative, Pinnacle 21 has released a…
Certara2020年10月30日
