Benefits of Automating, Accelerating and Unifying the SDTM Conversion Process

In light of regulatory requirements, CDISC SDTM is now the leading standard for representing clinical data. Still, the use of SDTM poses many challenges. Since EDC systems can't automatically generate SDTM datasets, converting the raw clinical data is a manual, lengthy and error-prone process. Additionally, the fact SDTM is set to support a broad array of clinical data elements means it is extensible and often open for interpretation which in turn creates many SDTM inconsistencies across studies. These inconsistencies together with the lengthy timelines of converting the data, prevent sponsors from performing cross-study analysis, increase regulatory submission costs and greatly defeats the purpose of using SDTM from the first place.

In this session, we will examine current industry trends and progress made in automating, accelerating and unifying the SDTM conversion process and in enabling true cross-study analysis within organizations.
Presented by
Eyal Wultz

President, Bioforum Group


Jeffery Doten
Professional Services Project Manager. Medrio

Jeffery Doten is a Professional Services Project Manager at Medrio. Jeffery is an educator, health promotion specialist, and technology enthusiast. He has a Public Health background and has worked in technology since 2008. Over the last 4 years, his focus has been on Clinical Technology software, working with EDC and IWRX platforms to help studies build software, stay on schedule and collect great data. At Medrio, Jeffery’s primary responsibilities center on user education and custom project management.

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