Building a Strong Foundation: Robust Metadata Repository (MDR) Framework for Automated Standard Compliant Data Mapping

Pharmaceutical and biotechnology companies operate within a constantly evolving regulatory landscape, where adherence to standards set by organizations like the Clinical Data Interchange Standards Consortium (CDISC) is crucial for submitting clinical trial data. In the area of clinical trial data management, information can originate from various sources and be stored across different platforms, systems, and […]

Importance of “Table, Listing and Figures” Automation in Clinical Trials

Tables, Listings, and Figures (TLFs) help to analyse and summarize datasets of a clinical study into an easily readable format. Statistical programmers along with inputs from biostatisticians create these TLFs. Once Lead statistician review/validate them, medical writers use the TLFs to create documents like clinical study reports (CSRs). Some TLFs are straight forward and easy […]