The rate of regulatory change in clinical trials is rapidly increasing. With FDA deadlines in place for standardized electronic submissions (December 2016) and FDA support for define.xml V1.0 ending in March 2018, Formedix CDISC standards experts have been inundated with questions and panic fuelled standards support inquiries.
Formedix is delighted to host a series of free CDISC standards focused webinars to help you understand the structure and fundamentals of the standards and prepare for impending changes to how clinical trial data is submitted to the FDA.
Using CDISC to optimize both new & legacy studies
- How to use CDISC data acquisition metadata for both new and legacy studies
- What is Define-XML? How does it fit within an end-to-end trial?
And, how it is useful for new and legacy studies?
- How to establish an end-to-end library, what it really consists of and what CDISC standards should be used.
How to utilize CDASH in multi-vendor EDC systems
The webinar aims to confront issues and questions often asked of Formedix regarding this CDISC standard.
Topics to be discussed include:
- What is CDASH?
- Best Practice for Using CDASH
- How does CDASH map to SDTM?
- Practical CDASH Mapping Examples
- Advantages of Using CDASH in Your Clinical Trials
Discover Define XML – practical uses today and a technical deep dive
Kevin Burges, Technical Business and Standards Director (the company’s very own “Standards Guru”) and CEO, Mark Wheeldon address questions frequently asked of Formedix regarding define.xml, combined with real world knowledge and expertise.
- Creating and re-using Proprietary, CDISC SDTM and ADaM dataset libraries with Define
- Define-XML: The Myths and the Realities. Your Clinical Trials Automated. Everywhere.
- Study Start-up: Define-XML aided CRF design & specification process optimization
- Study Conduct and Analysis: Automated dataset validation with define.xml
- The role of Define-XML in Legacy and Proprietary EDC dataset conversions
- Define-XML 2.0 enhancements: What do they mean to you?
- Define-XML 2.0 enhancements: Technical Deep Dive.
Formedix and Medidata partner to discuss ‘end-to-end automation using CDISC’
We are partnering with Medidata Solutions to bring you an exclusive webinar discussing “End-to-end Automation Using CDISC”. Hear from the experts Mark Wheeldon, Formedix CEO and Joshua Pines, EMEA marketing for Medidata Solutions, about how we’ve partnered to implement CDISC together across the entire end-to-end clinical trial process.
You will learn:
- How to leverage CDISC PRM standard to facilitate standardization downstream
- How to automate 97% of your Medidata Rave’s EDC system build
- How to map Rave datasets to CDISC SDTM datasets
- How to reuse source Rave and target SDTM dataset designs
- How to achieve time and cost savings across the entire end-to-end process.
Formedix and OmniComm team up for CDASH to SDTM mapping presentation
Targeted at senior Clinical Data Management, Clinical Systems and Clinical Pharmacology staff, the hour-long webinar will discuss in-depth the key processes in the CDASH to SDTM mapping procedure.
Rich Davies of OmniComm and Ed Chappell of Formedix share their insight into this complex and vital process.
Over the course of the live 60-minute webinar, the experts will discuss:
- The importance of standardized eCRFs and datasets
- Creating forms, edit checks, and workflow programming to design and build studies in OmniComm TrialMaster.
- Utilizing and reusing standardized trial components in OmniComm TrialMaster
- Using OmniComm TrialMaster to map from CDASH to SDTM
- Establishing libraries of SDTM designs and mappings for reuse, source-to-target traceability reporting, generation of ETL code and advanced metadata validation.