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.
Attendees will 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 will 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.
Attendees will have the opportunity to ask questions specifically related to their own organizational projects or specific challenges, and how best to address them.
Register to learn about the need for standardization and hear from CDISC themselves, including their guidance and approach to standards adoption.
Rhonda Facile, Vice President, Partnerships and Development, CDISC
Rhonda has over 30 years of experience in global clinical and standards development. She works with global stakeholders, including regulatory authorities, pharma, vendors, academics and SDOs in collaborative initiatives that extend and connect the CDISC standards. Their ultimate underlying goal is to work towards getting treatments to patients that need them.
Coretta (Thomas) Robinson, Program Manager, The University of Alabama (UAB)
Coretta has nearly 20 years’ experience in clinical trials management. She provides oversight and coordination on all aspects of clinical research projects. Coretta is responsible for coordinating and overseeing data collection and quality assurance, as well as developing reports and presenting evaluation findings to internal and external stakeholders. In data analysis, her role involves manipulating data, performing validation and edit checks, programming clinical data, automating data loads and analysis and ensuring rigorous quality controls. She develops methods for standard operating procedures (SOPs) and case report forms (CRFs) and is now leading the way in the Clinical Data Interchange Standards Consortium (CDISC) and standards adoption at UAB.
Russ Telford, Director of Biostatistics and Clinical Data Management, The University of Utah
Russell Telford, MAS, MA, BA is a Biostatistician at the University of Utah. He has more than nine years of experience in clinical research and eight years of experience in education. He currently serves as the Director of Biostatistics and Clinical Data Management. Prior to his current role, Russell was the Biostatistics Manager and a Biostatistician providing direct support to clinical research projects. He has expertise with a wide variety of systems and processes related to Good Clinical Data Management Practice (GCDMP) and statistical methods. Russell leads both clinical data management and statistical staff that provide direct support to research projects.
Ed Chappell, Solutions Consultant, Formedix
Ed Chappell has been working as a Solutions Consultant with Formedix for over 13 years. He has authored and now presents Formedix’s training courses for SEND, SDTM, Define-XML, ODM-XML, Define-XML and Dataset-XML. Ed was heavily involved in the development of the ryze dataset mapper and works closely with customers on SDTM dataset mapping. As an expert in clinical data programming, Ed also supports customers with Interim Analysis (IA) SDTM and the US Food and Drug Administration (FDA) SDTM clinical trial submissions.
Mark Wheeldon, CEO, Formedix
Mark Wheeldon is the Founder and CEO of Formedix. He is an active supporter of the Clinical Data Interchange Standards Consortium (CDISC) which Formedix has been a member of since its inception two decades ago. Mark is a member of the CDISC Industry Advisory Council (CAC), and strongly believes that a more efficient end-to-end clinical trial process lies in the successful implementation of data standards and clinical trial automation technologies.
Who Should Attend?
This webinar will benefit those responsible for or involved in the selection of a clinical metadata repository. It will also benefit those looking to introduce standardization into their clinical trial design and build process. This includes people working on data standards, data management, regulatory compliance (including CDISC) and governance in pharmas, biotechs, CROs, universities and medical device organizations, including:
- Regulatory Affairs
- Clinical Operations
- Clinical Affairs
- Project Management
What You Will Learn
In this webinar attendees will 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
Want to design and build clinical trials faster with less effort? Now you can, with our new clinical metadata repository (CMDR) and automation cloud platform, ryze. We’ve automated manual, labor-intensive processes, and given you the tools to standardize study build and integrate 3rd party platforms.
Simply house your standards and study library in the central MDR, then easily find, manage, and reuse content. Even import content from EDCs and e-clinical systems into ryze. You can design studies for leading EDCs – and see exactly how forms look in ryze without having to build your study.
Instantly convert datasets to SDTM, and make submission deliverables with the click of a button. And all effortlessly in line with CDISC standards. ryze is built on CDISC compliant templates, so compliance is enforced throughout study build. Plus, ryze is a cloud-based off-the-shelf suite, so there’s zero install and it’s ready to go when you are!
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