The need for standardization and CDISC: Insights from The University of Alabama, The University of Utah & CDISC
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The Clinical Data Interchange Standards Consortium (CDISC) compliance is now mandatory for clinical trial submissions to the US Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA). And for many academic institutions, this is now a condition of their grant funding. However, adopting CDISC standards isn’t just a necessity. It’s an important investment that enables more meaningful research, and easier data analysis, with deeper insights.
In addition, those who take steps to implement standards benefit from reuse. Rather than designing new studies from scratch, content can be reused across future studies and standards, enabling significant time and resource efficiencies.
Hear how the University of Alabama (UAB) and the University of Utah are tackling CDISC compliance and embracing the benefits of standardization. Experts from both universities tell the story of their compliance journey — their starting point; what they were looking to achieve; what they needed help with; the challenges they faced; what they achieved; and future aspirations.
You can learn about:
- The Clinical Data Interchange Standards Consortium (CDISC):
- Understanding compliance and why it’s needed for clinical trial submissions
- How to adopt and use CDISC standards
- Get guidance from the organization that sets the standards
- The need for standardization in trials
- The benefits of standardization in clinical trial design and build
- How technology can help with CDISC compliance and standardization
- Use case insights from the University of Alabama (UAB) and the University of Utah
Rhonda Facile – Vice President, Partnerships and Development, CDISC
Coretta (Thomas) Robinson – Program Manager, The University of Alabama
Russ Telford – Director of Biostatistics and Clinical Data Management, The University of Utah
Mark Wheeldon – CEO, Formedix
Ed Chappell – Solutions Consultant, Formedix
Organizations using our clinical trial software
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