Quanticate Blog

The History and Development of Pinnacle 21

by Clinical Programming Team

October 16, 2020

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.

A Guide to CDISC SDTM Standards, Theory and Application

by Clinical Programming Team

April 14, 2020

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

Integration of CDISC ADaM Datasets for ISS/ISE Submissions

by Clinical Programming Team

February 3, 2020

Integration of CDISC ADaM Datasets for ISS/ISE Submissions

In this article we share our experience of a recent integration using the ADaM standards in order to ensure the safety and effectiveness of interventions.

Why do a 3rd of Regulatory Submissions fail the Technical Rejection Criteria?

by Clinical Programming Team

August 6, 2018

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...

First Steps in Laboratory Dataset in SAS

by Clinical Programming Team

June 27, 2018

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...