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
