The Journey to Study Data Tabulation Model and Beyond

Clinical Trials, Life Sciences, Medical Device, Medical Device Clinical Trials,
  • October 21, 2015

Learn from industry experts Neil Vivian (OmniComm) and Ed Chappell (Formedix) as they delve into the journey from CDASH to SDTM and beyond…

  • The importance of standardization of eCRFs and datasets
  • Creating forms, edit checks and workflow programming to design and build TrialMaster
  • Utilizing and re-using standardized trial components in TrialMaster
  • Using TrialMaster to map from CDASH to SDTM
  • Beyond SDTM: Establishing libraries of SDTM designs and mappings for reuse, source to target traceability reporting, generation of ETL code, and advanced metadata validation

Speakers

Neil Vivian, Senior Director of Business Solutions, OmniComm Systems

Neil has been with OmniComm Systems for 6+ years and created the original Business Requirements for the TrialMaster Export Utility which has been extended to allow the automated mapping of CDASH to SDTM.

Ed Chappell, Consultancy Team Lead, Formedix

Ed has been with Formedix for more than 7 years, starting out in define validation and template design before moving onto metadata library creation and data migration. Ed provides CDISC Standards expertise on implementation of ODM, Define-XML, CDASH and SDTM.

Who Should Attend?

  • Heads of Clinical Data Management
  • Heads of Phase I Clinics
  • Heads of Operations
  • Heads of Clinic Systems
  • Heads of Clinical Pharmacology

Xtalks Partners

OmniComm

OmniComm Systems is a leading strategic software solutions provider to the life sciences industry. OmniComm Systems is dedicated to helping the world’s Pharmaceutical, biotechnology, CROs, research and medical device organizations maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organization drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive eClincal solutions from Phase I through late phase clinical trials with an extensive experience with over 4,000 clinical trials.

Formedix

Formedix is a leading provider of clinical trial automation software and consultancy services. Its solutions enable the removal of manual, expensive and inefficient tasks from clinical study setup, EDC build, validation and submission publication processes. Formedix works closely with organizations like CDISC to develop and advance clinical data standards, and to automate the end-to-end clinical trial process.

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