A Guide to Utilizing USDM from Study Concept to Study Execution

About this session

Part of Session 6, Track B: Study Design/USDM (Chair: Kent Letourneau, ICON).

Leveraging USDM does not have to start at the point of authoring a protocol but can start earlier in the Study Design process. Utilizing lessons learned in building a USDM based product suite, this presentation will explore how USDM can be utilized from defining a study, to authoring a protocol and supporting documents, and finally to enabling downstream system automation. We will discuss the challenges in building a USDM based product along with the adaptions we have explored to support capturing data in the study design space, study cost space, and operational study data space. Additionally, we will share real world end user and system integration challenges which are important to consider and plan for to enable the Digital Data Flow vision to reach its potential.

Speakers

• CD

  Christopher Damato

  Evinova AG

  Speaker

• AS

  Ali Soltani

  Evinova AG

  Speaker

• KL

  Kent Letourneau

  ICON

  Chair