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
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
Formatting Annotated Case Report Forms (aCRFs): Multiple copies and/or multiple versions of forms
Streamline aCRF formatting by mastering versions, repeated pages, and compliance essentials. Read the third blog…
Certara2020 年 10 月 9 日
