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. （纳斯达克股票代码：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
