A guide to CDISC standards. The Clinical Data Interchange Standards Consortium is an organization dedicated to helping to improve medical research by driving communication through data standardization. This data standardization enables
What is clinical trial software? It’s software that’s used by CROs, biotechnology, and pharmaceutical companies to facilitate clinical trials from conception to finish. For example protocol management, CRF design, metadata
Multiple origins for a Value in Define-XML 2. There are many common questions people have when creating Define-XML metadata for their datasets. One of these revolves around how to handle
An overview of CDISC standards. 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
CDISC standards in 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, careful decision
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,
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
Differences between Define 1.0 and Define 2.0.