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Trusted Since 1999 — 25+ Years of Excellence

Your Research,
Our Expertise

Full-service contract research organization delivering comprehensive clinical trial solutions — from regulatory approval to data management and beyond.

FDA
GCP
CDISC
GDPR
KVKK
25+
Years of Clinical Research
100+
Dedicated Professionals
300+
Clinical Studies Completed
IIV
All Study Phases Covered
Helios EDC Demo

Technology Platform

Helios EDC

Our proprietary electronic data capture ecosystem with built-in compliance, validated per FDA 21 CFR Part 11 and GAMP 5 guidelines.

Computerized System Validation (CSV)

IQ/OQ/PQ validated, 21 CFR Part 11 compliant, full audit trail

Rapid Study Deployment

Pre-built templates, drag-and-drop CRF design

ePRO, eConsent & Randomization

Patient-reported outcomes, electronic consent, double-blind randomization

Real-Time Monitoring & SDV

Live dashboards, automated queries, instant validation

Post-Market Surveillance (MDR)

Medical device performance and safety monitoring

Trusted by leading global pharmaceutical and medical device companies

20+Global Pharma Partners
I–IVAll Study Phases
25+Years of Partnership

Why MonitorCRO

Building Trust Through Experience

Trusted Local Partner

Trusted Local Partner

Deep understanding of Turkish regulatory landscape, Ministry of Health requirements, and local clinical trial ecosystem.

Integrated Technology

Integrated Technology

Our Helios EDC platform delivers faster study deployment, real-time insights, and seamless data management under one roof.

100+ Expert Team

100+ Expert Team

Full-time professionals across clinical operations, regulatory affairs, data management, medical writing, and quality assurance.

Frequently Asked Questions

Got Questions?

MonitorCRO is a full-service CRO offering clinical operations, regulatory affairs, medical writing, data management & biostatistics (powered by Helios EDC), pharmacovigilance, and quality assurance. All services comply with ICH-GCP.

Helios EDC is our proprietary electronic data capture platform — fully validated per FDA 21 CFR Part 11 and GAMP 5, with ePRO, eConsent, randomization, real-time monitoring, and computerized system validation (CSV) packages.

ISO 9001 (Quality Management), ISO 27001 (Information Security), ICH-GCP compliance, KVKK/GDPR compliance, CDISC Gold Membership, and FDA 21 CFR Part 11 validated systems.

Yes. Since 1999, we have partnered with leading global pharmaceutical companies and medical device manufacturers to conduct clinical trials across all phases.

Pediatric/neonatology, orphan drugs & rare diseases, medical device studies, early phase trials, compassionate use programs, and general medicine including bioequivalence research.

Ready to Partner With Us?

Let's discuss how our 25+ years of expertise can support your next study.