ISO9001:2015
Certification
Our commitment to high quality patient interviews has been independently verified. ISO certification reaffirms CLINIGMA®'s exceptional commitment to quality, ICH-GCP compliant interview solutions—enabling our clients to present trustworthy and complete patient experience data to regulatory authorities.
ISO9001:2015 certified
CLINIGMA® is ISO9001:2015 certified in:
“Designing, conducting, analyzing and reporting patient interviews in relation to clinical trials.” – DNV-GL
We achieved ISO9001:2015 certification in 2019 and recertification in 2025. This external validation formally recognizes our quality management system.
CLINIGMA® consistently delivers excellence in in-trial interview services and solutions. Our certification assures clients of our enduring commitment to quality, regulatory compliance, and innovation in the conduct and reporting of in-trial interviews.
Commitment to excellence
CLINIGMA® continues to assure stakeholders of its ongoing focus on quality and innovation according to regulatory standards. We prioritize customer satisfaction through continuous improvement, proactively identifying risks and solutions for robust and ICH-GCP compliant regulatory submissions.
Quality management system
Our quality assurance team implements a robust QMS that ensures consistent service delivery and process efficiency.
Risk-based thinking
We proactively identify risks and opportunities to enhance service reliability and performance.
Regulatory compliance
Our audit trails show how interview data is transformed into evidence for regulatory submissions in compliance with ICH-GCP.
Audits and inspections
CLINIGMA® ensures quality through regular audits and inspections, enhancing transparency and compliance.
Corrective and preventive actions
Our robust CAPA process identifies, investigates, and resolves quality issues, ensuring continuous improvement.
Client satisfaction
Our focus is on meeting and exceeding client expectations through continuous improvements.
A trusted interview provider
CLINIGMA® conducts high-quality, ICH-GCP compliant in-trial patient interviews. Discover how we make global patient research easy for you.
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