Increasing Productivity In Pharma R&D Starts With Data
This article discusses the growing volume of raw data collected during clinical research, and how…
Certara2025 年 6 月 25 日
Using SDTM Data to Produce Patient Narratives
In this blog, we look at how medical writers can use SDTM data produced by…
Certara2025 年 4 月 15 日
Exploring Common CDISC ADaM Conformance Findings
2025 年 3 月 27 日 ADaM data are required by the FDA and PMDA and accepted by…
Certara2025 年 3 月 27 日
FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format
2025 年 3 月 19 日 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…
Certara2025 年 3 月 19 日
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline
We look at the growing regulatory trend of rolling NDA and BLA submissions to help…
Certara2025 年 2 月 3 日
GlobalSubmit 4.0 Webinars
The world of electronic regulatory submissions is about to change with the introduction of eCTD…
Certara2024 年 12 月 3 日
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know
2024 年 12 月 3 日 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…
Certara2024 年 12 月 3 日
