Illustrative scenario · CROs
Seizure and sleep context between neurology visits
A CRO running an epilepsy study wanted richer between-visit data for its sponsor.
Challenge
The scenario's data and workflow challenges
- Paper seizure diaries were incomplete and arrived late.
- Sites had no context on sleep or triggers.
Data sources
Data sources in the illustrative workflow
- Seizure diaries
- Wearable sleep
- Medication adherence check-ins
Approach
The proposed collection and integration approach
1
Digital diary
Patients and caregivers logged events in the app.
2
Sleep data
Wearables added nightly sleep context.
3
Site view
Sites saw completeness and flagged gaps.
Workflow
- Site activation
- Patient onboarding
- Daily diary
- Completeness review
- Sponsor export
Outputs
Illustrative outputs for each team
- CRO clinical ops
- Diary completeness by site
- Sponsor
- Harmonized between-visit dataset
- Sites
- Fewer data queries
Outcomes
Results, once confirmed
We only publish measured outcomes that have been confirmed and approved.
- Outcomes are reviewed with the program and published only after confirmation.
- Diary completeness tracked for review
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