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
Anonymization vs. Redaction of Clinical Trial Data
January 17, 2025 The vernacular for disclosing pharmaceutical clinical trial results to the public may…
CertaraJanuary 17, 2025
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
ICH M12 Guidelines & Your Drug-Drug Interaction Package
We have provided an overview of the key changes to the ICH M12 drug-drug interaction…
CertaraJune 19, 2024
Demystifying CDISC, SDTM, and ADaM
Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…
CertaraMay 22, 2024
What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?
Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…
CertaraFebruary 2, 2022
