Layer 01 — Patient Pool Intelligence
Tell us about your programme
Disease area *required
Gene Therapy — Ultra-Rare
fewer than 1:50,000 patients
Gene Therapy — Rare Disease
1:2,000 – 1:50,000 patients
Rare Genetic Disease
monogenic or chromosomal
Rare Metabolic / Enzyme
LSDs, metabolic disorders
Rare Neurological
CNS, neuromuscular
Other Rare Disease
haematology, immunology, other
Development stage *required
Pre-IND
discovery to IND filing
IND-Ready
IND filed or imminent
Phase 1 / 1-2
first-in-human planned
Phase 2/3 Pivotal
registration-enabling
Pre-CRO Selection
evaluating CRO partners
Continue to Geography →
Layer 01–02 — Geography & Site Scope
Where will the trial run?
Primary trial geography *required
United States Only
FDA-regulated sites
US + Europe
FDA + EMA sites
Global (Standard)
US, EU, Asia-Pacific
Global + AfricaExtended
includes African site mapping
Africa-FocusedExtended
Nigeria and sub-Saharan Africa
Emerging Markets
LATAM, MENA, SE Asia
Diversity mandate
FDORA Diversity Action Plan Required
FDA mandate for diverse enrollment · race/ethnicity targets required
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Continue to Site Profile →
Layer 02 — Site Capability Assessment
Site & therapy requirements
Therapy modality *required
AAV Gene Therapy
adeno-associated viral vector
Lentiviral / Ex Vivo
cell-based gene therapy
mRNA / ASO / RNA
nucleic acid therapy
Small Molecule / Enzyme
ERT, substrate reduction
Cell Therapy / CAR-T
autologous or allogeneic
Other / Undecided
multiple or TBD
Long-term follow-up required?
LTFU Monitoring Required (≥ 5 years)
standard for gene therapy — major site capability constraint
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Continue to Constraints →
Layer 03 — Competitive Landscape & Constraints
Known constraints & competitive context
Competing trials in same indication?
Active or Planned Competing Trials Known
other sponsors targeting the same patient pool
Patient registry available?
Patient Registry or Natural History Study Exists
formal registry or NHS / other cohort data available
Timeline pressure *required
Urgent
FPI target < 12 months
Moderate
12–24 months to FPI
Flexible
> 24 months to FPI
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Generate Enrollment Risk Index →
Layer 04 — Enrollment Risk Index
Your enrollment risk profile
This Enrollment Risk Index is a directional pre-assessment generated by Zonra's feasibility framework. Scores are based on programme parameters and known epidemiological and site capability factors. A full Zonra engagement includes comprehensive patient pool modelling, global site database analysis, competitive landscape mapping, and a live readout with your team — delivered within 3–4 weeks. Zonra Inc. · Delaware, USA · zonra.bio · mariam@zonra.bio