Illustrative scenario · Pharma & biotech
Long-term follow-up after a one-time therapy
After a one-time gene therapy, a sponsor must follow patients for many years.
Challenge
The scenario's data and workflow challenges
- Site-based follow-up is costly and patients drift away over time.
- Long gaps between contacts mean late awareness of changes.
Data sources
Data sources in the illustrative workflow
- Structured PROs
- Site and lab records
- Optional wearables
Approach
The proposed collection and integration approach
1
Remote check-ins
Scheduled structured check-ins replaced some site contacts.
2
Change alerts
Study teams were told when reported measures changed.
3
Retention view
Engagement tracked per patient and per site.
Workflow
- Treatment
- Enrollment in app
- Scheduled check-ins
- Change review
- Annual dataset
Outputs
Illustrative outputs for each team
- Medical affairs
- Long-term follow-up dataset
- Study team
- Retention and change alerts
- Patients
- Fewer site trips
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.
- Retention tracked for review
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