Veridian Pharma · OBS-PMR-001
Long-term safety surveillance of verexitide in T2DM
PASS-style 5-year real-world safety registry, contracted by EMA commitment. Database lock executed on schedule; CSR drafting underway.
Sit-rep
Status
Database lock
Health
On track
Forecast end
Oct 18, 2026
+3d vs plan
Projected EAC
14.8M USD
-200k USD vs contract
Live activity
No activity yetKey performance indicators
Threshold colour is supplementary to the on-target / at-risk / breached label.
- Enrolment
- 4,800 / 4,800 (100%)
- Patient-years accrued
- 12,140
- Loss-to-follow-up
- 6.4%
- Query aging (>14d)
- 2 open
- Protocol deviations
- 88
- Projected DBL variance
- 0 days
- Budget burn
- 93%
- Forecast EAC
- $14.8M
Timeline & milestones
Bar shows planned span; tick marks current forecast end. Markers are colour-coded by milestone status (labels in tooltip / table below).
| Milestone | Planned | Actual / forecast | Variance | Status |
|---|---|---|---|---|
| FPI | Sep 1, 2020 | Sep 9, 2020 | +8d | Complete |
| 25% enrolment | Jun 30, 2021 | Jul 4, 2021 | +4d | Complete |
| 50% enrolment | Feb 28, 2022 | Feb 15, 2022 | -13d | Complete |
| 75% enrolment | Oct 15, 2022 | Oct 2, 2022 | -13d | Complete |
| LPI | Jun 30, 2023 | Jun 22, 2023 | -8d | Complete |
| LPLV | Mar 31, 2026 | Mar 28, 2026 | -3d | Complete |
| Database lock | May 15, 2026 | May 15, 2026 | — | Complete |
| CSR draft | Jul 30, 2026 | Aug 2, 2026 | +3d | In progress |
| CSR final | Oct 15, 2026 | Oct 18, 2026 | +3d | Planned |
| Severity | Title | Owner | Mitigation | Status |
|---|---|---|---|---|
| Medium | Vendor archive handoff for 6-year retention obligation | Records Lead | Long-term archive contract executed; index re-verified. | Mitigating |
| Low | Late-arriving AE narratives at DB lock | Pharmacovigilance Lead | All narratives QC-cleared; lock executed without amendment. | Closed |
| Low | Publication concurrency with sponsor PR cycle | Medical Writing Lead | Joint editorial calendar agreed. | Mitigating |
Resources
| Role | Headcount | FTE | Monthly rate | Monthly cost |
|---|---|---|---|---|
| CRA | 2 | 0.5 | 18k USD | 9k USD |
| Data Management | 3 | 1.5 | 16k USD | 23k USD |
| Pharmacovigilance | 2 | 1.0 | 18k USD | 18k USD |
| Biostatistics | 2 | 1.4 | 23k USD | 32k USD |
| Medical Writing | 2 | 1.2 | 20k USD | 24k USD |
| Total | 11 | 5.6 | — | 106k USD |
Financials
Contracted budget
15.0M USD
EBV spent
13.9M USD
93% of contract
EAC (estimate at completion)
14.8M USD
-200k USD vs contract
Burn vs time elapsed
93% / 94%
broadly aligned
Recent activity
Provenance events (24h)
124
Staging items pending
2
Signatures (7d)
9
View provenance for this study →View staged records for this study →
Study goals
Quantify long-term MACE and renal AESI rates against label assumptions
Deliver final CSR within EMA-committed timeline
Publish primary outcome in a peer-reviewed journal within 12 months of CSR final
Maintain regulator-grade ALCOA+ traceability across 12,000 patient-years