1. 🎯 Sprint Summary
| Sprint | Sprint 10.4 · Pharma Trial Network |
| Duration | 9 - 29 Sep 2030 |
| Module | Pharma trial network |
| Goal | 5 active trials live · per-site digital protocol · NPRA reporting · ≥ 500 trial patients · adverse event SLA |
| Capacity | 6 FTE + Founder 1.0 + Doc Zam 0.5 + Pharma BD 1.0 + Compliance Lead 0.5 |
| Velocity | 95 SP |
| Demo | 29 Sep 2030 |
2. 🧩 Module Scope
- Per-site digital trial protocol — investigator dashboards · patient enrollment workflow
- Adverse event monitoring — automated SAE detection · regulator alert · NPRA reporting
- Pharma sponsor portal — site overview · enrollment metrics · safety reports
- Regulatory reporting — NPRA + FDA + EMA submission workflows
- Per-trial randomisation engine — secure block randomisation · audit-grade
- 5 trials onboarded — Pfizer (cardio) · Roche (onco) · Novartis (DM) · AstraZeneca (resp) · MOH-MY (anti-TB)
- Trial patient consent UX — multi-language · readability tested · withdrawal option
- GCP + ICH-E6 compliance — comprehensive audit trail
3. 🚦 Pre-Sprint Gate
- Sprint 10.3 closeout · 3 university RCTs stable
- 5 pharma sponsor MOUs signed
- NPRA pharma trial sponsor accreditation
- Pharma BD lead onboarded
- Per-trial randomisation engine spec approved
4. 📅 Day-by-Day Plan
D1-2Mon-Tue 9-10 Sep · Kickoff + Per-Site Protocol
Sprint planning · investigator dashboard scaffolding.
Sprint planning · investigator dashboard scaffolding.
D3-4Wed-Thu 11-12 Sep · Adverse Event Monitoring + NPRA
SAE detection · NPRA reporting workflow.
SAE detection · NPRA reporting workflow.
D5Fri 13 Sep · Mid-Sprint Demo #1
Per-site protocol + AE monitoring demo.
Per-site protocol + AE monitoring demo.
D6-7Mon-Tue 16-17 Sep · Pharma Sponsor Portal + Reporting
Sponsor dashboard · safety reports · regulatory submission.
Sponsor dashboard · safety reports · regulatory submission.
D8-9Wed-Thu 18-19 Sep · Randomisation Engine + Consent UX
Block randomisation · multi-language consent.
Block randomisation · multi-language consent.
D10Fri 20 Sep · Mid-Sprint Demo #2
Sponsor portal end-to-end.
Sponsor portal end-to-end.
D11-12Mon-Tue 23-24 Sep · Pfizer + Roche Trials Live
2 trials recruiting.
2 trials recruiting.
D13Wed 25 Sep · Novartis + AstraZeneca Trials Live
2 more trials live · 4 total.
2 more trials live · 4 total.
D14Thu 26 Sep · MOH-MY Anti-TB Trial Live
5th trial live · MOH-MY anchor.
5th trial live · MOH-MY anchor.
D15Fri 27 Sep · GCP + ICH-E6 Audit
External audit · 5-site coverage.
External audit · 5-site coverage.
+Mon 29 Sep · Sprint Demo + Retro
5-pharma joint announcement · 10.5 prep.
5-pharma joint announcement · 10.5 prep.
5. 📦 Deliverables
| FR | Item | SP |
|---|---|---|
| FR-10.4.1 | Per-site digital trial protocol | 13 |
| FR-10.4.2 | Adverse event monitoring · NPRA reporting | 13 |
| FR-10.4.3 | Pharma sponsor portal · safety reports | 8 |
| FR-10.4.4 | NPRA + FDA + EMA reporting workflows | 8 |
| FR-10.4.5 | Block randomisation engine (audit-grade) | 8 |
| FR-10.4.6 | 5 pharma trials onboarded and recruiting | 13 |
| FR-10.4.7 | Multi-language trial patient consent UX | 5 |
| FR-10.4.8 | GCP + ICH-E6 external audit clean | 8 |
| FR-10.4.9 | ≥ 500 trial patients enrolled | 5 |
| TOTAL | 81 SP |
6. 👥 Team Capacity
| Role | Allocation | Focus |
|---|---|---|
| Eng Lead / BE | 1.0 FTE | Per-site protocol · randomisation engine |
| BE Dev 2 | 1.0 FTE | Adverse event monitoring · NPRA integration |
| FE Dev | 1.0 FTE | Sponsor portal · investigator dashboard |
| DevOps | 0.5 FTE | Audit-grade infra · monitoring |
| Founder | 1.0 FTE (heavy) | 5-pharma BD · MOH-MY anchor |
| Doc Zam | 0.5 FTE | Clinical safety oversight · AE protocol |
| Pharma BD Lead | 1.0 FTE | 5-sponsor contract close |
| Compliance Lead | 0.5 FTE | GCP + ICH-E6 audit · regulatory coordination |
7. 🔔 Sprint Ceremonies
- Mon 9 Sep 9am — Sprint Planning + 5-pharma BD kickoff (120 min)
- Daily 9am — Standup
- Fri 13 + Fri 20 Sep 4pm — Mid-sprint demos
- Thu 26 Sep 4pm — MOH-MY anti-TB trial launch ceremony
- Fri 27 Sep — GCP + ICH-E6 external audit (1 day)
- Mon 29 Sep 9am — Sprint Demo + 5-Pharma Joint Announcement (120 min)
- Mon 29 Sep 11am — Retro + 10.5 plan
8. 🩺 Sign-off Items
- 5 pharma trials live · ≥ 500 patients enrolled
- Per-site digital protocol verified by 5 sponsors
- AE monitoring · NPRA reporting tested with mock SAEs
- Block randomisation engine audit-grade · clean integrity proof
- Multi-language consent UX tested across 4 ASEAN languages
- GCP + ICH-E6 external audit clean
- NPRA + FDA + EMA reporting workflows verified
- 5-pharma sponsor public attestation
9. 🎬 Demo Schedule — 29 Sep 2030
| Time | Segment |
|---|---|
| 0-10 | v4.0 update · research RCT metrics · why pharma B2B |
| 10-25 | Per-site digital protocol · Pfizer cardio trial demo |
| 25-40 | Adverse event monitoring · automated SAE detection demo |
| 40-55 | Pharma sponsor portal · Roche oncology dashboard |
| 55-70 | Block randomisation engine · audit-grade verification |
| 70-85 | 5-pharma joint announcement · Pfizer/Roche/Novartis/AstraZeneca/MOH-MY |
| 85-95 | Founder closing · 10.5 ASEAN AI standard walkthrough |
10. 🛡️ Contingency
| Risk | Trigger | Response |
|---|---|---|
| Pharma sponsor delay | Slow contract | Phase exit at 3 trials · 4-5 in 10.5 |
| SAE detection regression | Missed adverse event | Conservative thresholds · mandatory dual-review · advisor escalation |
| NPRA integration issues | Sandbox unstable | Manual reporting fallback · escalate |
| Randomisation integrity | Audit flag | Lock randomisation seeds · post-hoc audit · regulator review |
| Trial patient enrollment slow | < 300 by demo day | Increase site count · mobile app trial visibility |