Clinical trial protocols remain largely static documents, requiring research sites to manually interpret, translate, and re-enter protocol details across systems and workflows. This creates duplication, delays, and variability in downstream activities such as clinical trial management system calendar builds, Medicare coverage analysis, budget development, contract review, and patient outreach configuration. This session will explore how digital data standards and digitization methods can help convert protocol content into structured, machine-readable data that support more standardized, efficient, and reusable site workflows. Panelists will discuss emerging standards, sponsor and contract research organization adoption considerations, and the practical implications of moving to data-driven protocol execution. Using site-centered operational examples, the session will examine where digital protocols can reduce manual effort, improve consistency, and support faster study activation. Attendees will leave with practical considerations for evaluating digital protocol readiness and identifying workflows that may benefit from structured protocol data.

Using site-centered operational examples, the session will examine where digital protocols can reduce manual effort, improve consistency, and support faster study activation. Attendees will leave with practical considerations for evaluating digital protocol readiness and identifying workflows that may benefit from structured protocol data.

CEU: 1.0 ACRP

Speakers:

• Bill Illis, Workstream Leader, Digital Data Flow (Protocol Digitalization), TransCelerate BioPharma Inc.

• James Wurdeman, SVP Product Lead, Advarra