A Guide to CDISC SDTM Standards, Theory and Application
This blog provides a background on CDISC SDTM Standards, and the advantages of SDTM's application
This blog provides a background on CDISC SDTM Standards, and the advantages of SDTM's application
This blog post looks at the FDA's Technical Rejection Criteria for Study Data and despite demographic dataset (DM for SDTM submissions), define.xml, the Subject-Level Analysis Dataset (ADSL for ADaM submissions) and Trial summary (TS) being...
The laboratory dataset is one of the core safety datasets and, at first glance, it could appear intimidating. This article will illustrate checks that are worth applying at the very beginning of programming work – these could be in addition...
A Quanticate blog post exploring Analysis Data Model and ADaM Datasets, and how it is widely used in the submission of clinical trial information.
A Quanticate blog post highlighting guidelines for creating Custom or Non-Standard CDISC STDM Domains.
In this video Quanticate explores the creation of two ADaM datasets; ADPC and ADPP for Pharmacokinetic (PK) Analysis in clinical trials
Quanticate's latest blog explores generating CDISC Compliant PK Workflows as part of Pharmacokinetic Analyses.
When using SAS Business Intelligence in Clinical Trials, this infographic explores the process of how data arrives into the Web Report Studio
This Quanticate blog reviews the evolving standards of CDISC SDTM Therapeutic Area Domains
Following on from the previous blog posts on Integrated Summaries we can explore the use of CDISC SDTM for Cost and Quality efficient ISS/ISE studies