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
Best Practices for Annotated CRFs
In this webinar, Amy Garrett reviews published guidance from regulatory agencies and provides best practices…
Certara2020 年 7 月 30 日
Understanding the Duplicate Records Validation Rules
In this blog, we clarify the meaning & purpose of the duplicate records validation rules,…
Certara2020 年 7 月 7 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…
Certara2020 年 7 月 2 日
Mapping Considerations for Screen Failure, Not Assigned, and Not Treated Subjects
In this blog, we clarify the best practices when mapping data for screen failure, not assigned,…
Certara2020 年 6 月 18 日
