The do’s and don’ts of define.xml
Discover the 6 dos and don’ts of creating compliant define.xml files for FDA submission with…
CertaraJune 27, 2025
Increasing Productivity In Pharma R&D Starts With Data
This article discusses the growing volume of raw data collected during clinical research, and how…
CertaraJune 25, 2025
SEND V4.0 – What to expect and when to expect it
April 24, 2025 As the Standard for Exchange of Nonclinical Data (SEND) continues to evolve…
CertaraApril 24, 2025
Managing clinical metadata for your vendors, studies, and datasets
April 21, 2025 Clinical research is witnessing an evolution, driven by the increasing complexities of…
Gilbert HunterApril 21, 2025
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…
Peggy ZornMarch 19, 2025
Gain nonclinical drug safety insights with real-time data analysis
February 24, 2025 Efficient drug development relies on informed decision-making. For toxicologists, having timely access…
CertaraFebruary 24, 2025
The history of Pinnacle 21
February 21, 2025 It was late 2007. Mad Men was the hottest show on TV.…
CertaraFebruary 21, 2025
