FAQ
Frequently Asked Questions
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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.
Early phase trials, Phase II to IV studies, medical device studies, pediatric and neonatology, orphan drugs and rare diseases, and PK and bioequivalence research.