Zonra provides enrollment risk modeling for gene therapy trials in rare and ultra-rare disease — stress-testing site strategy before sponsors engage a CRO or activate a single site.
It is rarely predicted. Sponsors spend millions activating sites before anyone has modeled whether the patients can actually be found.
Most sponsors assess enrollment viability after CRO selection and site contracting. By then, reversing course costs $500K+. The problem was baked in from the start.
In disorders with fewer than 500 diagnosed patients globally, standard site metrics are useless. Genotype stratification, undiagnosed ratios, and geographic clustering are the real variables.
Long-term follow-up requirements, vector manufacturing constraints, and specialized administration capabilities filter the eligible site list from hundreds to single digits.
The most genetically diverse continent on earth — with the highest undiagnosed rare disease burden — is absent from every feasibility model built on Western site databases.
Our feasibility report models every variable that predicts enrollment failure — delivered before CRO engagement, before site activation, before the clock starts running.
Diagnosed vs. undiagnosed ratio, genotype distribution, geographic clustering, and registry gap analysis. We find where the patients are before you look for sites.
Gene therapy infrastructure readiness, LTFU program capacity, investigator experience index, and competing trial load — scored across every candidate site globally.
Active and planned trials competing for the same patient pool, with sponsor mapping and projected enrollment timeline pressure.
A scored summary with specific mitigation recommendations by site, region, and patient identification strategy. Actionable, not theoretical.
That is not a data gap. That is a structural failure — and it is costing sponsors the most scientifically valuable populations on earth. Africa's unmatched genetic diversity is a research asset that has been systematically ignored.
Zonra's long-term mission is to build the feasibility infrastructure that makes African sites investable for rare and genetic disease programs — from site identification and investigator mapping to registry development and regulatory pathway guidance.
Talk to us about Africa strategy →Zonra works with organizations where enrollment failure is existential — not just expensive.
Gene therapy and rare disease developers approaching pivotal studies who need to validate enrollment feasibility before investor scrutiny intensifies. Your runway depends on your trial timeline.
University-originated rare disease programs transitioning to clinical development. You have the science. Zonra gives you the enrollment evidence base for IND submissions and grant applications.
Global programs exploring African sites for the first time. Zonra maps patient populations, qualified sites, and regulatory pathways — so your Africa expansion is evidence-based from day one.
Tell us about your program. We'll scope a feasibility report that tells you exactly where your enrollment risk lives — before it becomes a crisis.