A guide to CDISC standards used in the clinical research process. The Clinical Data Interchange Standards Consortium is an organization dedicated to helping to improve medical research by driving communication through
All you need to know about SDTM. The SDTM standard is a CDISC standard, and it means the Study Data Tabulation Model. If you want to know more about
9 SDTM Mapping Scenarios you need to know. One of the most challenging programming problems in a clinical trial involves SDTM mapping. That is mapping datasets from a non-CDISC structure to
Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for half my life now, ever since we realized how it could transform
How CDISC standards fit into the drug development process. The clinical trial process is a long, expensive, complicated one that often ends in failure. That means to have a successful outcome,
3 things you should know about ADaM standards. One of the most important standards when it comes to clinical trial submission, the Analysis Data Model (ADaM) outlines how to create analysis
Using NCI Controlled Terminology for Standardizing Data. The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM,
What CDISC standards are required for regulatory submissions? It’s a pretty safe bet that most people’s first introduction to CDISC is through the Study Data Tabulation Model (SDTM). This is
Using Define-XML for Dataset Design. In the past sponsors submitting to FDA were required to submit a PDF describing their submission datasets. As we all know PDF is great for viewing