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.
Clinical Data Quality is of the utmost importance when working towards a regulatory submission. These 4 methods are a must have in the new digital era.
This blog provides a background on CDISC SDTM Standards, and the advantages of SDTM's application
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.
Quanticate explores how a big SAS code can be made straightforward and easy to understand, with techniques and best practices to achieve this in your SAS programs.
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...
This Quanticate blog examines the implement of electronic data capture (EDC) systems in clinical trials by highlighting the benefits of moving away from paper-based studies, the thought behind the EDC database design and role of outsourcing
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.