Regulatory Compliance

CLINIGMA^® conducts, analyzes, and reports patient interviews with the same rigor as clinical trial data—in full compliance with ICH-GCP and local regulations. By ensuring patient safety, data integrity, and traceability at every stage, we deliver regulatory-compliant patient experience data you can trust.

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Uncompromising standards for global patient research

As patient experience data is increasingly recognized as critical to regulatory decision-making, CLINIGMA^® treats all patient data in strict compliance with ICH-GCP, with our certified interview portal, robust Quality Management System, and expert team. With complete data traceability, regular internal and external audits, and a culture of continuous improvement, we deliver research solutions that uphold patient safety, data integrity, and regulatory compliance worldwide.

Regulatory excellence & ethical compliance

Our strict adherence to ICH-GCP E6(R3) ensures that every patient interaction is conducted to the highest global standards of clinical research. By embedding GCP principles into all processes and training, we safeguard participant rights, guarantee data integrity, and uphold scientific rigor—ensuring that our research consistently withstands regulatory scrutiny worldwide.

Source data traceability & regulatory standards

CLINIGMA^®’s FDA 21 CFR Part 11 and EMA-compliant systems ensure full source data traceability in line with ALCOA++ principles. Our platform delivers regulatory submission–ready data with built-in audit trails, secure electronic records, and validated signatures—meeting global inspection standards and guaranteeing data integrity for FDA, EMA, and international authorities.

Declaration of Helsinki & patient protection

Guided by the Declaration of Helsinki (latest revision, 2024), we place patient welfare at the center of all activities. Our ethical frameworks ensure informed consent, respect for autonomy, inclusion, and equitable treatment, with enhanced safeguards for vulnerable populations. Through independent ethics oversight and rigorous monitoring, we deliver regulatory-ready patient interview data that upholds the highest ethical and scientific standards for global submissions and publications.

International data privacy & compliance

Our GDPR-aligned and internationally compliant systems are built with privacy-by-design and privacy-by-default principles, supported by robust technical and organizational safeguards that go beyond regulatory minimums. We ensure secure global data processing, uphold participant rights, and enable compliant cross-border transfers through ongoing impact assessments and continuous monitoring—for ongoing data privacy and compliance standards you can trust.

Global expertise, local knowledge

We operate across multiple regions, maintaining a global presence while adapting to specific local regulatory requirements. CLINIGMA^®can seamlessly deliver consistently high quality ICH-GCP compliant interviews anywhere in the world.

300+

Qualitative
researchers worldwide

100+

Interview
languages available

For safe and ICH-GCP compliant
patient research

Find out how we can provide you with regulatory compliant global patient research.