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
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Why do a 3rd of Regulatory Submissions fail the Technical Rejection Criteria?
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...
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First Steps in Laboratory Dataset in SAS
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...
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Creating Custom or Non-Standard CDISC SDTM Domains
A Quanticate blog post highlighting guidelines for creating Custom or Non-Standard CDISC STDM Domains.
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![The Creation of ADaM Datasets for Pharmacokinetic (PK) Analysis [Video]](https://www.quanticate.com/hs-fs/hubfs/Live%20Webinar%20Featured%20Image.jpg?width=800&name=Live%20Webinar%20Featured%20Image.jpg)
The Creation of ADaM Datasets for Pharmacokinetic (PK) Analysis [Video]
In this video Quanticate explores the creation of two ADaM datasets; ADPC and ADPP for Pharmacokinetic (PK) Analysis in clinical trials
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SAS Business Intelligence - A Perceptive Vision in Clinical Trials
When using SAS Business Intelligence in Clinical Trials, this infographic explores the process of how data arrives into the Web Report Studio
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CDISC SDTM Therapeutic Area Domains - a Rapidly Evolving Standard?
This Quanticate blog reviews the evolving standards of CDISC SDTM Therapeutic Area Domains
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Using CDISC SDTM to Improve Cost and Quality in Integrated Summaries
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
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