What Breaks First When You Go DDF?

About this session

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

Honestly, we thought structured protocols would be the easy part. The technology was ready USDM, ICH M11 alignment, API driven study builds. What caught us off guard was everything else. This presentation walks through what actually happened when we moved from Word-based protocols to DDF-enabled digital authoring. Some things worked immediately: syntax templates caught ambiguities our teams had been reconciling manually for years. Semantic search surfaced prior studies we had forgotten existed. Automated EDC configuration cut weeks from our timelines. Other things required iteration‚ getting authors comfortable with structured fields, convincing stakeholders that upstream investment pays downstream dividends, integrating with systems that weren't quite ready. We share real metrics alongside real friction points. No theoretical frameworks here; just practical lessons from an implementation still evolving. If you're considering DDF adoption or stuck midway through, this session offers a candid look at the path forward.

Speakers

• UJ

  Udiksha Jaiswal

  Sycamore Informatics

  Speaker

• BQ

  Bill Qubeck

  Sycamore Informatics

  Speaker