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
The Complete Guide to CDISC Standards Management
Learn how to easily manage and validate against CDISC data standards our complete guide to…
Simona Colucci2024 年 10 月 30 日
Adopting CDISC Standards: Our Journey With CDISC
In this case study, we explore our 23-year partnership with CDISC and we look at…
Simona Colucci2024 年 10 月 8 日
Using Define-XML for Faster, Better Quality and More Efficient Studies
We explore progressive uses of Define-XML in trials, and why you should design submission datasets…
Simona Colucci2024 年 9 月 25 日
How to Use CDISC’s ODM Standard for CRF Design
Over the last decade, our industry has become familiar with Clinical Data Interchange Standards Consortium…
Simona Colucci2024 年 9 月 25 日
Why Should You Use LOINC Codes For SDTM?
2024 年 9 月 16 日 In this blog, we take a detailed look at LOINC Codes and…
Simona Colucci2024 年 9 月 16 日
The SDTM Mapping Process Simplified
SDTM mapping can be one of the most challenging programming problems in a clinical trial…
Simona Colucci2024 年 9 月 16 日
What Are SDTM Supplemental Qualifiers?
We touched on the SDTM supplemental qualifier in the SDTM mapping process simplified. In this…
Simona Colucci2024 年 9 月 16 日
Define.xml Submission Checklist
Learn how to create a compliant Define.xml submission package with our Define.xml submission checklist, and…
Simona Colucci2024 年 8 月 29 日
