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Quality assurance

Iris Pharma ensures that your clinical trials are performed to the highest standards, in compliance with the ICH-GCP requirements, European guidelines and applicable local regulatory laws. Iris Pharma maintains its own Standard Operating Procedures (SOPs), which govern all critical activities in trial management, submission, monitoring and clinical writing. According to your requirements, we can also follow your own SOPs.

 

Our Quality Assurance department ensures SOP management, internal quality control (checking of the trial master file), and audit of the Investigational Medicinal Product (IMP) suppliers and investigational sites.