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
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
Formatting Annotated Case Report Forms (aCRFs): Document properties, bookmarking and table of contents
Discover essential tips for formatting annotated CRFs, from dual bookmarking to document properties. Read the…
Certara2020 年 9 月 10 日
Exploring Common CDISC ADaM Dataset Conformance Findings
What you need to know when validating your CDISC ADAM datasets During the regulatory review…
Certara2020 年 9 月 3 日
Formatting Annotated Case Report Forms (aCRFs): Part 1
Discover essential tips for formatting aCRFs with clarity and regulatory compliance in mind. Read the…
Certara2020 年 8 月 12 日
