Appendix
Supporting detail without crowding the demo
The landing page now leads with the workflow. This appendix carries the heavier rationale, workflow notes, and pilot assumptions.
Problem framing
Frontline teams often capture potential adverse events in free-text operational notes. That creates missing minimum case facts, inconsistent seriousness routing, and avoidable reviewer rework. The result is slower handoff and weaker auditability in a workflow that should be fast, structured, and defensible.
- Potential adverse events often surface inside routine patient-support interactions rather than inside purpose-built safety software.
- When the first signal lands in free-text notes, reviewers inherit missing minimum case facts, inconsistent urgency cues, and avoidable reconstruction work.
- The first operational problem to solve is intake quality and handoff reliability, not a full downstream PV platform replacement.
Solution boundary
Safety Intake Desk introduces a single guided intake flow, reviewer queue, follow-up tasks, duplicate checks, and handoff export. It focuses on one pilot program and one primary intake channel so adoption, data quality, and cycle-time impact can be measured quickly.
- KISS: one program, one primary intake channel, one workflow slice.
- YAGNI: no full PV platform features in v1.
- DRY: one intake model reused across queue, tasks, export, and reporting.
- SOLID: separate intake capture, review decisions, tasking, and metrics into clear workflow responsibilities.
Workflow logic
The operating sequence stays intentionally narrow: capture, triage, follow-up, handoff, and audit visibility.
- Weeks 1-2: Discovery: Confirm pilot program, map current intake path, baseline completeness and turnaround metrics, and lock acceptance criteria.
- Weeks 3-5: Design: Define intake schema, queue states, follow-up rules, and handoff packet format with operations and reviewer stakeholders.
- Weeks 6-10: Build: Implement intake, queue, tasks, duplicate suggestions, audit trail, and dashboard instrumentation in a sidecar workflow module.
- Weeks 11-12: UAT + Training: Replay historical examples, validate edge cases, run role-based training, and complete privacy/access checks before go-live.
- Weeks 13-16: Pilot: Run production pilot, review weekly KPIs, tune field labels and rules, and decide expand, iterate, or stop.
Why this wedge
The MVP earns the right to expand only if it improves first-mile capture without pretending to replace the full safety stack.
- Right scope for v1: Solve first-mile capture and triage only. Keep regulatory submission, literature monitoring, and broader PV platform functions out of scope.
- Operations-first design: Start from existing patient/program context, require core intake fields, allow save-incomplete, and drive structured follow-up instead of abandoning partial cases.
- Reviewer-centered workflow: Queue states and decision points make reviewer work visible, measurable, and auditable while preserving qualified human judgment.
- Compliance-aware architecture: Use SSO, program-scoped access, field masking, and export-based handoff to fit sensitive-data workflows without forcing a core system rewrite.
Pilot delivery assumptions
A 12 to 16 week pilot remains realistic only if the architecture stays honest, the scope stays narrow, and success is measured tightly.
- Minimum-field completeness: >=95%. Share of intake cases containing required reporter, patient, product, and reaction fields at handoff.
- Reviewer assignment speed: <=1 hour serious, <=1 business day non-serious. Measures queue responsiveness and urgency routing performance.
- Duplicate handoff rate: <5%. Tracks data hygiene before downstream transfer.
- Eligible-user adoption: >=80%. Confirms the workflow is being used when events are eligible for intake.
Execution risks I would manage explicitly
Scope inflation
Keep submission tooling, literature review, and broader PV workflows explicitly out of v1.
User friction
Limit intake to minimum required facts and support save-incomplete instead of forcing full completion at first touch.
Integration drag
Treat the real product as a sidecar module and the static MVP as a communication artifact, not a fake production build.
Short version
Safety Intake Desk is a deliberately narrow MVP for first-mile adverse-event intake: capture the initial
signal cleanly, preserve incomplete drafts, route reviewer work visibly, and hand complete cases off without
pretending to replace the downstream PV system.