Frequently Asked 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.