1. Define scope and the patient need
Start with the therapy and the patient journey, not the features. Write down which patients the program serves, which barriers it addresses (access, onboarding, injection training, financial navigation, follow-up), and what the program will deliberately not do. A one-page scope agreed by medical, market access, compliance and the operator prevents most later rework.
- Therapy area, eligible population and expected enrolment channels
- Services in scope: education, reminders, nurse calls, refill coordination, logistics
- Non-promotional boundaries reviewed by medical and compliance
- Markets and languages (Arabic-first for Saudi patients)
2. Enrolment and consent
Enrolment is where trust is won or lost. Patients should understand what the program offers, who runs it, which data is collected and how to withdraw. Consent should be recorded per purpose and be easy to revisit, aligned with the Saudi Personal Data Protection Law (PDPL).
- Referral routes: physician, pharmacy, hotline or self-enrolment
- Purpose-specific consent with a clear withdrawal path
- Identity and eligibility checks proportionate to the program
- Data hosted and processed according to agreed residency requirements
3. Onboarding
The first weeks on therapy carry the most questions. Plan a welcome sequence, training content and a first contact by a nurse educator, and decide which events trigger a human follow-up rather than an automated message.
4. Ongoing adherence support
Combine reminders, patient-reported check-ins and educator outreach. Define escalation rules in advance — for example missed doses or a reported side effect — so the team knows who acts and how quickly. Keep the program measurable by logging each touchpoint.
| Role | Main responsibility |
|---|---|
| Patient | Reminders, check-ins, education, contacting the team |
| Nurse educator | Onboarding, outreach, triage of reported issues |
| Treating physician | Clinical decisions; receives agreed summaries |
| Program manager | Operations, quality, service levels |
| Sponsor | Aggregated, de-identified reporting only |
5. Safety reporting
Any program that talks to patients will receive adverse event information. Agree with the sponsor's pharmacovigilance team how events are captured, routed and reconciled, the reporting timelines, and how staff are trained. Build the routing into the workflow rather than relying on manual forwarding.
6. Sponsor reporting and measures
Agree the measures before launch so data is captured from day one. Typical operational measures include enrolment, time to first contact, retention on program, touchpoints completed and reported issues resolved. Clinical or economic outcome claims need a separate evaluation design.
Launch-readiness checklist
- Signed scope and non-promotional review
- Consent wording approved in Arabic and English
- Pharmacovigilance routing tested end to end
- Escalation rules and service levels documented
- Staff trained and roles assigned
- Reporting dashboard agreed with the sponsor
- Data residency and access controls confirmed
Related: compare platform options on the PSP Connect page, model scenarios in the PSP value estimator, and review hosting requirements in the Data Residency & Compliance Checklist.
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