Clinical Trials Without Bias

Continuous bias monitoring for your trial data. Issues detected automatically, explained clearly, corrected before submission.

Bias Threatens Trial Validity

From demographic underrepresentation to methodological flaws, bias compromises scientific validity, distorts treatment effects, and triggers regulatory rejection. Most issues remain invisible until submission—when it's too late.

80%+

of clinical trials contain systematic bias

~$0.5M

cost per Phase III trial amendment due to bias

30%

potential cost reduction with bias correction

Cost of Late Discovery

What it costs when bias is caught at submission vs. during the trial

At FDA/EMA Review
Post-hoc analyses$200K - $500K
Advisory committee prep$500K - $1.5M
Delay costs (12-18 mo)$1M - $3M
Bridging study (if required)$3M - $8M
Total potential cost$2M - $10M+
During Trial (Clinequal)
Protocol adjustment$50K - $150K
Targeted re-enrollment$100K - $300K
Retention interventions$50K - $200K
Bridging studyAvoided
Total typical cost$200K - $650K

Estimates based on Phase II/III trials. Actual costs vary by therapeutic area, trial size, and regulatory jurisdiction.

Business and Clinical Impact

Financial Risk

Clinical trials cost $17M (Phase I) to $200M (Phase III) on average. Bias-driven trial amendments add further costs, and studies with high risk of bias show exaggerated treatment effects that fail to replicate, wasting development investment.

Regulatory Scrutiny

FDA and EMA increasingly require documented evidence of representative enrollment and robust methodology. Trials with inadequate randomization, poor blinding, or unrepresentative populations face rejection.

75

Documented Bias Types

Manual review catches some. Regulatory checklists flag a few more. Clinequal systematically detects all of them.

Detected automatically. Explained clearly.

How It Works

Your trial data flows through four stages. Bias is caught early, explained clearly, and corrected before it becomes a regulatory problem.

Detect

Continuous scanning across 21 trial-relevant bias types. Issues surface as they emerge, not at submission.

Explain

Explainable AI traces each bias to its root cause—site selection, protocol design, or enrollment patterns.

Simulate

Model corrections before implementing them. See how changes affect bias metrics in real time.

Report

Audit-ready documentation for regulatory submission, aligned with Cochrane methodology.

Interactive Demo

See It in Action

Explore bias detection on sample clinical trial datasets. No signup required.

clinequal.com/demo
Try the Demo

2 sample trials • ~2 min walkthrough

Recognition & Achievements

Selected from 495 applicants for Fit4Start Luxembourg. Winner of the US-Italy Hackathon and Startcup Campania Social Impact Prize.

July 2025

That's a Hackathon! Winner

US-Italy Hackathon for Innovative Business Ideas

Naples

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October 2025

Social Impact Prize

Startcup Campania

5th Place Overall

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December 2025

National Pitch

Premio Nazionale Innovazione

Ferrara

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2025

Fit4Start Finalist

Luxembourg Accelerator Program

Luxembourg

Academic Collaborations

Politecnico di MilanoUniversità di Napoli Federico IILuxembourg Institute of Science and TechnologyLinköping UniversityUniversity of OxfordUniversity of LuxembourgKTH Royal Institute of TechnologyKarolinska Institute

Leadership Team

Expertise spanning AI/ML, bioinformatics, healthcare data science, software engineering, and regulatory compliance. Advised by scientists in the top 2% most cited globally.

Andrea de Giorgio

Andrea de Giorgio

CEO

PhD Industrial Engineering (KTH), 10+ years AI/ML, serial entrepreneur

Felicia Burtscher

Felicia Burtscher

CPO

MSc Bioinformatics (Imperial), MBA, 10+ years healthcare data science

Nicola Luigi Bragazzi

Nicola Luigi Bragazzi

CSO

MD, PhD, 1,000+ publications, top 2% most cited scientists, Cochrane Reviewer

Pasquale Junior Montò

Pasquale Junior Montò

CTO

BSc Computer Science, technical architect of the Clinequal platform

Enrico De Cupertinis

Enrico De Cupertinis

CCO

Doctor in Design for Community, branding & digital marketing expert

Eleonora Di Napoli

Eleonora Di Napoli

CFO

Master's Economics, Management & Sustainability, ESG specialist

Reduce Regulatory Risk with Representative Datasets

Schedule a consultation to see how Clinequal addresses bias in your trial data before submission.

info@clinequal.com