The integration of machine learning-based & LLM based AI into clinical trial data management & clinical operations remains elusive, not just operational and technological challenges. The promise of AI transforming clinical trials is yet to unfold. Here

Auto-coding, the process of automatically assigning standardized codes to clinical trial data, has primarily relied on string matching techniques. When data terms match exactly with those in the dictionary such as MedDRA, coding is straightforward and accurate.

Remember when it seemed like clinical trials had to be slow and full of tedious paperwork? We all believed that manual data entry and constant human oversight were essential to ensure everything was accurate and safe. But

The adoption of Large Language Models (LLMs), is on the horizon in clinical trial, promising significant productivity improvements in both data management and clinical operations. While AI shows great potential, its integration into clinical workflows faces several

nadmin March 6, 2024 0 Comments

While working with define.xml, usually we are focused on its creation for submission to regulatory agencies. The key advantage towards adopting this burdensome standard is that it is machine readable. Well, recently I tested the machine readability

nadmin March 6, 2024 0 Comments

CDASH is positioned as a standard to collect data to provide traceability from data collection to SDTM. It comes with recommendations for data collection for 16 common data domains, such as demographics and adverse events. The documentation includes

nadmin March 6, 2024 0 Comments

FDA submission requirements to use CDISC's SEND data standard is going to be applicable for studies starting end of this year (and end of next year for certain study types). Now is a good time for CROs

nadmin March 6, 2024 0 Comments

SAS has a powerful alternative - SQL procedure – to traditional data step processing. A large group of SAS programmers love to use Proc SQL, especially those with databases or computer science background. I started using Proc

nadmin March 6, 2024 0 Comments

In 2013 CDISC came out with define XML specification version 2.0. Unlike previous version 1.0, which was focused on SDTM, version 2.0 define.xml is designed equally well for SDTM, SEND and ADaM. Define.xml version 2.0 is now

nadmin March 6, 2024 0 Comments

Define.pdf can be a great supplement to define.xml for multiple reasons. Apache FOP software (http://xmlgraphics.apache.org/fop/) can beautifully render the define.xml to define.pdf when used with proper stylesheet file. We have developed a stylesheet file xml2fo.xsl by modeling