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
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
