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RELIABLE OUTCOME 
DELIVERED ON TIME 

We guide medical device innovation safely through clinical and regulatory pathways. 

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ABOUT US

Ilita CRO is a certified, full-service Clinical Research Organization specializing in medical devices, biotechnology, and digital health.​​

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OUR MISSION 

Our mission is simple yet ambitious:

To make professional, reliable CRO and regulatory services accessible to companies of all sizes — without ever compromising the quality, accuracy, or integrity of the outcome.

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KEY VALUES 

FINANCIAL
EFFICIENCY

78% OF STUDIES COMPLETED WITHIN BUDGET 

TIMELY
DELIVERY

OVER 85% OF STUDIES COMPLETED ON OR AHEAD OF Schedule

USABILITY EXCELLENCE

100% ACCEPTANCE OF USABILITY REPORTS BY THE FDA

STREAMLINED
PROCESSES 

PRE-SUBMISSIONS WITHOUT DELAYING CLINICAL PLANS

REGULATORY
SUCCESS

REGULATORY SUBMISSIONS WITH ZERO NSE

SERVICES

Strategic Planning

Indication Analysis
Regulatory Pathway Design
Timeline Optimization
Risk Mitigation Plan

Protocol Development & Feasibility 

Protocol Design 
AI Powered Site Selection
Feasibility Assessment
Widespread International Reach

Site Management Excellence

Patient Recruitment and Retention Support
On-Site and Remote Monitoring 
Logistic Support 

Data Masters 

EDC Programming 
Data Management
Medical Review 
Standardized Dictionary Coding (MedDRA & WHODrug)
CDISC Submission Support 

Regulatory Support

Pre-Submission Consultation 
510K Application Preparation
Technical Documentation Assistance 
FDA Correspondence Management
EU? 

Usability Studies

We design and manage usability studies that ensure your medical device is intuitive, safe, and compliant with global regulatory expectations. From protocol development to final reporting, our experts guide you through every step of the formative and summative evaluation process.  

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LETS TAKE THE NEXT STEP 

Have a project in mind or just want to explore possibilities?

We’d love to hear about your device and help you plan its path to market.

CONTACT 

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ITALY 

Email: benital@ilita-cro.com

​WhatsApp: +1 330 285 7222

​Mobile: +39 328 382 6690

ISRAEL

Email: rafaelw@ilita-cro.com

​Mobile: +972 52 229 0161​​​​​​

ADDRESS
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ITALY 

Via Giuseppe Casaregis 13, Genova

U.S. 

163 N. 22nd Street, Columbus, Ohio

ISRAEL

8 Nahal Alexander St., Tsur Yitskhak

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Reliable  Outcome .
Delivered on Time.

 

 

© 2025 by Ilita

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