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
The Clinical Data Interchange Standards Consortium is an organization dedicated to helping improve medical research by driving interoperability through data standardization. Formedix has been strong advocates for the use of CDISC data
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,
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, SEND
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 a
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