What It Actually Takes: Lessons from Production USDM Adoption and the Path to Digital Data Flow

About this session

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

The Digital Data Flow vision promises end-to-end automation grounded in USDM, but the path from unstructured protocols to conformant, operationally useful structured data is far more complex than it appears. Drawing on real-world production USDM use, this presentation maps the engineering and domain challenges organizations should anticipate: semantic ambiguity in protocol documents, the gap between valid USDM and useful USDM, the vocabulary alignment problems that emerge at scale, and the validation rigor required before downstream systems can reliably consume structured protocol data. We share what the ecosystem still needs (from tooling gaps to standard extensions) and illustrate the downstream workflows that become possible when these challenges are solved: automated consent generation, screening derivation, and cross-system interoperability.

Speaker

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  Bill Lynch

  Chief Technology Officer · HumanTrue

  Speaker