The History and Development of Pinnacle 21
Pinnacle 21 has evolved and knowledge of its software has become an indispensable skill of every statistical programmer who works with CDISC standards.
Pinnacle 21 has evolved and knowledge of its software has become an indispensable skill of every statistical programmer who works with CDISC standards.
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.
In this video Quanticate explores the creation of two ADaM datasets; ADPC and ADPP for Pharmacokinetic (PK) Analysis in clinical trials
This Quanticate blog reviews the evolving standards of CDISC SDTM Therapeutic Area Domains