Archive


Category: cdisc

  • 4 Reasons Why You Shouldn’t Ignore CDISC Data Standards

    A quick recap: Who are CDISC and what do they do? The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the impact of clinical research data by establishing and promoting the use of data standards. Basically, these standards make clinical data easier to understand and interpret. “We develop and advance data […]

  • Formedix Partnered with CDISC to Give Free Access to CDASH-Compliant eCRFs

    Formedix and CDISC Join Forces to Provide Free Access to Ready-to-Use, CDASH-Compliant eCRFs for Accelerated Clinical Trial Set-Up Formedix, a leading provider of clinical trial software solutions, has collaborated with CDISC, the global clinical research data standards development organization, to create a novel portal providing free access to ready-to-use, CDASH-compliant, annotated electronic case report forms (eCRFs). […]

  • An overview of CDISC standards

    Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it could transform our business by enabling the rapid design and build of clinical trials. We quickly focused our company around the use of CDISC standards, and are now industry leaders […]

  • 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 and ADaM standardize the structures to use when collecting and submitting data, but what about the data values themselves? This article gives an overview of CDISC’s standardized controlled terminology and how it […]

  • How do CDISC standards fit into the drug development process?

    Introduction The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential. And so are data standards! The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to […]

  • How do CDISC standards fit into the drug development process?

    Introduction The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential. And so are data standards! The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to […]

  • 3 things you should know about ADaM standards

    One of the most important standards when it comes to clinical trial submission is the Analysis Data Model (ADaM). It outlines how to create analysis datasets and associated metadata. This in turn allows a statistical programmer to generate tables, listings, and figures (TLFs) more easily and ensures traceability. That means that reviewers can review and approve […]