Quality Assurance
Our rigorous quality assurance processes ensure every aspect of our global operations comply with ICH-GCP and local data privacy laws—to protect patient safety and data integrity for regulatory submissions.
For ICH-GCP compliant solutions
CLINIGMA® conducts, analyzes, and reports patient interviews with the same rigor as clinical trial source data—in full compliance with ICH-GCP and local privacy laws. By ensuring patient safety, data integrity, and traceability at every stage, we deliver regulatory-compliant patient experience data you can trust.
Our QA systems and experienced team provide you with high-quality patient interview data anywhere in the world
Experienced quality assurance team
Our quality assurance team combines deep knowledge of industry best-practice and world-class certifications to solve complex challenges with precision and efficiency.
Through our ongoing commitment to quality and innovation, we maintain and exceed regulatory standards.
Deep industry knowledge
Forward thinking approach
Excellence in quality management
We turn risk into opportunity. Our risk-based approach identifies and mitigates challenges before they arise, ensuring your research stays on track.
Through innovative tools, rigorous procedures, and real-time client feedback from customer satisfaction evaluations, we exceed expectations.
Turning risks into opportunities
Listening to client feedback
Rigorous quality standards
Our rigorous quality assurance processes guarantee that every clinical trial interview meets the highest standards of safety, accuracy, and integrity.
Comprehensive quality assurance frameworks for all patient experience data
Assurance patient experience data meets evolving regulatory standards
Validation of data collection methods and analytical approaches
Audit-ready documentation and traceability systems
Compliance with ICH-GCP and other regulatory standards
Data security & privacy
Our investment in IT systems and processes ensure your patient experience data is always protected and secure.
GDPR, HIPAA, PIPL, CNIL-compliant data handling and storage systems
Secure data transfer and collaboration platforms
Patient consent management and privacy protection
protocols
Robust patient safety reporting systems
Regulatory-grade cybersecurity measures
Integrated IT Practices
Security and quality are the foundations of our IT processes. Through a proactive, solutions-driven approach, we ensure that every interaction on the CLINIGMA® Portal is seamless, reliable, and patient-centric. Our commitment to continuous improvement means you can rely on CLINIGMA® to deliver excellence through:
Defined IT standards and requirements that establish clear guidelines for technology implementation
Comprehensive supplier assessments ensuring our partners meet our rigorous quality standards
Robust access controls protecting sensitive data while maintaining efficient workflows
Regular audit trail and user access reviews maintaining system integrity and security
Our compliance commitment
Our experts navigate complex requirements with ease to safeguard your interview data.
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