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,
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
Formedix is an all-in-one fully integrated platform to design and build your clinical trial – without any coding knowledge.
Made for pharmas, biotechs and CROs, the Formedix metadata repository and clinical trial automation software makes it quick and easy to find, manage, reuse and share your metadata. The result? You can design, build and submit your trials much faster than before.
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