1. 🎯 Sprint Summary
| Sprint | Sprint 10.3 · Clinical Research Platform (RCT) |
| Duration | 19 Aug - 8 Sep 2030 |
| Module | Clinical research recruitment platform |
| Goal | 3 university partners onboarded · IRB workflow live · MOH research permits processed · ≥ 2 active RCTs recruiting · GCP audit clean |
| Capacity | 6 FTE + Founder 0.8 + Doc Zam 0.5 + Research Advisor + Compliance Lead 0.5 |
| Velocity | 90 SP |
| Demo | 8 Sep 2030 |
2. 🧩 Module Scope
- De-identified patient pool — explicit opt-in · pseudonymisation · cohort filter for eligibility
- IRB workflow — protocol submission · ethics committee tracking · approval audit
- MOH research permit — application + tracking workflow · NMRR (National Medical Research Register)
- GCP compliance audit trail — every consent · withdrawal · adverse event logged
- Eligibility matching — automated screening based on inclusion/exclusion criteria
- Researcher portal — university dashboard · cohort analytics · trial enrollment
- 3 university partnerships — UM (cardiology RCT) · UKM (oncology RCT) · USM (diabetes RCT)
- Patient communication — opt-in via mobile app · transparent consent UX
3. 🚦 Pre-Sprint Gate
- Sprint 10.2 closeout · 10K+ employees enrolled
- 3 university LOIs signed (UM, UKM, USM)
- Research advisor onboarded (Prof Dr Adeeba Kamarulzaman)
- NMRR integration sandbox access granted
- GCP compliance external auditor engaged
- Patient consent UX reviewed by advisor + ethics
4. 📅 Day-by-Day Plan
D1-2Mon-Tue 19-20 Aug · Kickoff + De-Identification Pipeline
Pseudonymisation · opt-in flow.
Pseudonymisation · opt-in flow.
D3-4Wed-Thu 21-22 Aug · IRB Workflow + NMRR Integration
Protocol submission · NMRR API.
Protocol submission · NMRR API.
D5Fri 23 Aug · Mid-Sprint Demo #1
De-identification + IRB demo.
De-identification + IRB demo.
D6-7Mon-Tue 26-27 Aug · Eligibility Matching + Researcher Portal
Automated screening · university dashboard.
Automated screening · university dashboard.
D8-9Wed-Thu 28-29 Aug · GCP Audit Trail + Adverse Event Logging
Comprehensive audit · regulator reporting prep.
Comprehensive audit · regulator reporting prep.
D10Fri 30 Aug · Mid-Sprint Demo #2
Researcher portal end-to-end.
Researcher portal end-to-end.
D11-12Mon-Tue 2-3 Sep · UM + UKM RCT Live
First two trials recruiting · cardiology + oncology.
First two trials recruiting · cardiology + oncology.
D13Wed 4 Sep · USM RCT Live · Patient Consent UX
Diabetes RCT live · advisor review of consent UX.
Diabetes RCT live · advisor review of consent UX.
D14Thu 5 Sep · GCP External Audit
3-day GCP compliance audit · clean report deliverable.
3-day GCP compliance audit · clean report deliverable.
D15Fri 6 Sep · Stability + 100-Patient Test
≥ 100 patients enrolled across 3 RCTs.
≥ 100 patients enrolled across 3 RCTs.
+Mon 8 Sep · Sprint Demo + Retro
3-university joint announcement · 10.4 prep.
3-university joint announcement · 10.4 prep.
5. 📦 Deliverables
| FR | Item | SP |
|---|---|---|
| FR-10.3.1 | De-identified patient pool · pseudonymisation | 13 |
| FR-10.3.2 | IRB workflow · ethics committee tracking | 13 |
| FR-10.3.3 | NMRR integration · MOH research permit | 8 |
| FR-10.3.4 | GCP audit trail · adverse event logging | 13 |
| FR-10.3.5 | Automated eligibility matching | 8 |
| FR-10.3.6 | Researcher portal · cohort analytics | 8 |
| FR-10.3.7 | 3 university RCTs live and recruiting | 13 |
| FR-10.3.8 | GCP external audit clean | 8 |
| FR-10.3.9 | ≥ 100 patients enrolled across 3 RCTs | 5 |
| TOTAL | 89 SP |
6. 👥 Team Capacity
| Role | Allocation | Focus |
|---|---|---|
| Eng Lead / BE | 1.0 FTE | De-identification · GCP audit trail |
| BE Dev 2 | 1.0 FTE | NMRR integration · eligibility matching |
| FE Dev | 1.0 FTE | Researcher portal · patient consent UX |
| DevOps | 0.5 FTE | GCP audit infra · monitoring |
| Founder | 0.8 FTE | University BD · advisor coordination |
| Doc Zam | 0.5 FTE | Clinical oversight · advisor liaison |
| Research Advisor | 0.5 FTE | GCP standards · ethics review |
| Compliance Lead | 0.5 FTE | GCP audit · NMRR coordination |
7. 🔔 Sprint Ceremonies
- Mon 19 Aug 9am — Sprint Planning + Research Advisor Intro (90 min)
- Daily 9am — Standup
- Fri 23 + Fri 30 Aug 4pm — Mid-sprint demos
- Wed 4 Sep 2pm — Consent UX advisor review (90 min)
- Thu 5 Sep — GCP external audit (3 days)
- Mon 8 Sep 9am — Sprint Demo + 3-University Joint Announcement (90 min)
- Mon 8 Sep 11am — Retro + 10.4 plan
8. 🩺 Sign-off Items
- 3 university RCTs live and recruiting (UM · UKM · USM)
- ≥ 100 patients enrolled across 3 RCTs
- IRB workflow validated by 3 university ethics committees
- NMRR integration tested with MOH
- GCP external audit clean · zero major findings
- De-identification verified by external privacy auditor
- Patient consent UX reviewed by ethics advisor · approved
- Adverse event logging tested with mock incidents
9. 🎬 Demo Schedule — 8 Sep 2030
| Time | Segment |
|---|---|
| 0-10 | v4.0 update · employer wellness metrics · why research B2B |
| 10-25 | De-identification pipeline · pseudonymisation walkthrough |
| 25-40 | IRB workflow · ethics committee tracking demo |
| 40-55 | Researcher portal · UM cardiology RCT recruitment |
| 55-70 | Patient consent UX · opt-in flow demo |
| 70-80 | 3-university joint announcement · principal investigators speak |
| 80-90 | Founder closing · 10.4 pharma trial walkthrough |
10. 🛡️ Contingency
| Risk | Trigger | Response |
|---|---|---|
| IRB approval delay | Ethics committee slow | Phase exit at 2 RCTs · 3rd in 10.4 |
| GCP audit findings | Critical compliance gaps | Hot-fix · re-audit · slip cert if needed |
| Patient enrollment low | < 50 in week 3 | Marketing push via mobile app · trial visibility |
| NMRR integration issues | MOH sandbox unstable | Manual NMRR submission fallback |
| University BD delay | Contract negotiation slow | Anchor LOIs · contract signature post-launch |