Enabling data science to support cell therapy clinical trials. In this case study, Ian Hollingsworth, the Programme Manager for the ATTC (Advanced Therapy Treatment Centres), looks at the collaborative partnership that
All you need to know about SDTM. The SDTM standard is a CDISC standard, and it means Study Data Tabulation Model. If you want to know more about CDISC standards
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
Introduction to CDISC standards. The Clinical Data Interchange Standards Consortium is an organization dedicated to helping improve medical research by driving interoperability through data standardization. Formedix have been strong advocates for the use
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 datasets and
Using NCI Controlled Terminology for Standardizing Data. Use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND and
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