Using SDTM Data to Produce Patient Narratives
In this blog, we look at how medical writers can use SDTM data produced by…
CertaraApril 15, 2025
Exploring Common CDISC ADaM Conformance Findings
March 27, 2025 ADaM data are required by the FDA and PMDA and accepted by…
CertaraMarch 27, 2025
FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format
March 19, 2025 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…
CertaraMarch 19, 2025
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline
We look at the growing regulatory trend of rolling NDA and BLA submissions to help…
CertaraFebruary 3, 2025
GlobalSubmit 4.0 Webinars
The world of electronic regulatory submissions is about to change with the introduction of eCTD…
CertaraDecember 3, 2024
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know
December 3, 2024 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…
CertaraDecember 3, 2024
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…
CertaraNovember 22, 2024
