Results / Clinical research study setup
US CLINICAL RESEARCH ORGANIZATION · OPERATIONS

Protocol data prepared for study setup review.

Coordinators at a US clinical research organization were manually transferring protocol details into their study platform: visit schedules, procedures, windows, and structured fields. We built a proof of concept that extracts those details and prepares a reviewable study-setup packet.

The problem

A new study setup requires a dense protocol PDF to be converted into structured information: overview fields, visit schedules, procedures, and a matrix linking each procedure to its relevant visit. The work is repetitive but requires care. Visit windows expressed in weeks and months were also being converted into days manually in a purpose-built Excel sheet for each study.

What we built

We delivered a scoped proof of concept that processes a real protocol from start to finish. Narrative pages use text extraction. Schedule-of-activities tables use visual extraction so visit columns, procedure rows, and footnotes remain available. The workflow produces structured study-setup data, an Excel workbook, and a Word outline for review by the CRIO team.

ONE PROTOCOL, ONE PASS
Protocol PDF
Read & triaged
Setup packet
59overview fields
13visits scheduled
169matrix rows

The workflow does not write to the live CRIO environment. It prepares materials for a qualified person to check before any system update is considered.

What the site team said

Coordinators reviewed the output jointly. The visit-window conversion alone replaces the Excel sheet one coordinator previously created to convert weeks and months into days. With the corrected procedure matrix, the team estimated a saving of approximately 45 minutes per study setup.

Next phase

The proof of concept intentionally ends at review. The proposed next phase is a workflow that creates and updates the study shell in CRIO, retaining a human review step before any data is committed.

Is study setup consuming time that should go to higher-value coordination work?

We can review one structured-document workflow, identify its review requirements, and define a realistic first implementation boundary.

Discuss your workflow