The eCTD Submission Process: Tips and Tricks for Drug Development Success
Our experts compiled the tips and best practices you need to know for a successful…
Certara2022 年 11 月 22 日
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
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
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
