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…
Simona Colucci2025 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…
Mahumood Hameed2025 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…
Evan Richardson2025 年 2 月 3 日
GlobalSubmit 4.0 Webinars
The world of electronic regulatory submissions is about to change with the introduction of eCTD…
Danielle Pillsbury2024 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…
Danielle Pillsbury2024 年 12 月 3 日
Clinical Metadata Standardization: Evaluating the Importance of a Metadata Repository in Clinical Trials
Whether you’re considering a metadata repository or want to learn about clinical metadata standardization, our…
Danielle Pillsbury2024 年 11 月 22 日
