Quality & Compliance — IDDCR Global Research
Quality & Compliance
Rigorous quality management and regulatory compliance at the heart of everything we do.
Our Quality Framework
Quality and regulatory compliance are the foundation of everything we do at IDDCR. Our quality management system is designed to ensure that every study we deliver meets the highest standards of scientific integrity, data quality and regulatory compliance.
Standards & Certifications
ICH GCP E6(R2)
All clinical operations conducted in full compliance with ICH Good Clinical Practice guidelines.
ISO 9001:2015
Quality management system certified to ISO 9001:2015 across all service lines.
21 CFR Part 11
Electronic records and signatures managed in compliance with FDA 21 CFR Part 11 requirements.
GDPR Compliant
Data privacy and protection practices aligned with GDPR requirements for all EU subject data.
Quality Pillars
Inspection Readiness
Our processes and documentation are maintained to support regulatory inspection readiness at all times.
CAPA Management
Structured corrective and preventive action processes ensure issues are resolved and recurrence is prevented.
Risk-Based Monitoring
We apply risk-based approaches to quality oversight, focusing resources where they have the greatest impact.
Continuous Improvement
Regular quality reviews and lessons-learned processes drive ongoing improvement across all service lines.
Quality You Can Rely On
Contact us to learn more about our quality management system and how we ensure regulatory compliance across all studies.
Request a Proposal