Clinical Trial Feasibility Intelligence

The Zonra model
identifies where
enrollment fails
before it does.

Zonra applies a proprietary feasibility framework to rare and genetic disease programmes, giving sponsors the intelligence to act on site strategy, patient identification, and geographic scope before any spend is committed.

80%
of trials fail to meet
enrollment timelines
up to $8M
lost per day of
enrollment delay
55%
of trials terminated
due to poor enrollment
80% of trials fail to meet their enrollment timeline
55% of trials are terminated due to poor enrollment
Enrollment delays cost sponsors up to $8M per day
Rare diseases in children: 72% are genetic in origin
Gene therapy programmes in active development: 400 globally
In ultra-rare disease fewer than 1 in 2,000 patients are diagnosed
Fewer than 20% of candidate sites qualify for gene therapy programs
80% of trials fail to meet their enrollment timeline
55% of trials are terminated due to poor enrollment
Enrollment delays cost sponsors up to $8M per day
Rare diseases in children: 72% are genetic in origin
Gene therapy programmes in active development: 400 globally
In ultra-rare disease fewer than 1 in 2,000 patients are diagnosed
Fewer than 20% of candidate sites qualify for gene therapy programs
The Zonra framework

Four analytical layers.
One enrollment risk score.

Every programme runs through the same four-layer framework. The output is a scored risk profile with site-level recommendations, ready to act on.

Layer 01
Patient pool intelligence

Diagnosed and undiagnosed population estimates, genotype stratification, geographic clustering, and patient registry gap analysis. The model locates where patients are before site selection begins.

Layer 02
Site capability assessment

Gene therapy infrastructure readiness, long-term follow-up capacity, vector handling requirements, investigator experience scoring, and competing trial load. Sites are ranked globally.

Layer 03
Competitive landscape mapping

Active and planned trials competing for the same patient pool. Sponsor profiles, projected enrollment timelines, and patient access pressure modeled across each geography.

Layer 04
Enrollment Risk Index

A composite score synthesising all four layers, with site-level and region-level mitigation recommendations. A decision-ready intelligence document, not a research summary.

How it works

Access the intelligence
before the clock starts.

01
Programme scoping

Disease area, development stage, geography, and known constraints. The framework is calibrated to your programme, not applied as a template.

02
Framework analysis

All four layers run across your programme, drawing on epidemiological registries, published literature, proprietary site data, and competitive intelligence sources.

03
Intelligence delivery

A structured intelligence document with your Enrollment Risk Index, a scored site list, and mitigation recommendations. Followed by a live readout with your team.

04
Timeline

Three to four weeks from scope call to delivery, within pre-IND and pre-CRO engagement windows.

Zonra Feasibility Analysis
Standard engagement · 3 to 4 weeks
Patient pool intelligence model
Core
Site capability scoring, global
Core
Competitive landscape mapping
Core
Enrollment Risk Index with recommendations
Core
Africa site and patient mapping
Extended
LTFU infrastructure readiness module
Extended
Regulatory pathway brief, FDORA and diversity
Extended

The intelligence produced in each engagement contributes to the Zonra site and patient database, improving model accuracy across future programmes.

Begin an engagement
Extended capability

The Zonra model covers geographies that standard feasibility tools ignore.

Most feasibility databases are built on Western site networks. For sponsors whose programmes require diverse patient populations, or who are exploring sites beyond Europe and North America, the standard model has a structural gap.

Zonra's extended coverage includes Africa site and patient mapping — qualified investigator identification, site readiness assessment, and patient registry analysis across African geographies. Built on primary research, not inherited assumptions.

Discuss extended coverage
400+
gene therapy
programmes globally
55%
of trials terminated
for poor enrollment
20%
of sites qualify
for gene therapy
$8M
lost per day of
enrollment delay
Who engages Zonra

Programmes where the cost
of uncertainty is highest.

01
Pre-Series B biotechs

Gene therapy and rare disease developers approaching pivotal studies. The Zonra model validates enrollment feasibility before the programme is locked in.

02
Academic spinouts

Rare disease programmes moving from academic discovery into clinical development. Zonra provides the enrollment evidence base that IND submissions require.

03
Sponsors navigating diversity requirements

Programmes required to demonstrate diverse patient enrollment under FDORA or similar mandates. Zonra identifies qualified sites and patient populations in underrepresented geographies.

Know before
you commit.

Tell us about your programme. Zonra will scope the right engagement for your disease area, geography, and development stage.

mariam@zonra.bio Connect on LinkedIn