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…
Certara2025 年 6 月 27 日
Increasing Productivity In Pharma R&D Starts With Data
This article discusses the growing volume of raw data collected during clinical research, and how…
Certara2025 年 6 月 25 日
SEND V4.0 – What to expect and when to expect it
2025 年 4 月 24 日 As the Standard for Exchange of Nonclinical Data (SEND) continues to evolve…
Certara2025 年 4 月 24 日
Managing clinical metadata for your vendors, studies, and datasets
2025 年 4 月 21 日 Clinical research is witnessing an evolution, driven by the increasing complexities of…
Gilbert Hunter2025 年 4 月 21 日
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…
Certara2025 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…
Peggy Zorn2025 年 3 月 19 日
Gain nonclinical drug safety insights with real-time data analysis
2025 年 2 月 24 日 Efficient drug development relies on informed decision-making. For toxicologists, having timely access…
Certara2025 年 2 月 24 日
The history of Pinnacle 21
2025 年 2 月 21 日 It was late 2007. Mad Men was the hottest show on TV.…
Certara2025 年 2 月 21 日
