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PtCRIN aims to implement a QUALITY MANAGEMENT SYSTEM for Clinical Research and  ensure that overall process at multiple levels of the clinical research will be conducted in compliance with ICH and ISO 9001 standards (when applicable).

Established Quality Management standards will ensure high quality service, data integrity and proper study conduct. The quality Management System for Clinical trials includes processes, data and documentation associated with clinical research activities.

An excellent Center for clinical research must comply with the following requirements:
- Investigators must be science-driven, committed to carry out clinical trials from their one initiative and publish the obtained data in peer-review journals.
- Certification in Quality for clinical trial procedures; 
- Certification and training of all clinical trial staff in Good Clinical Practices;
- Reliability in terms of recruited patients.

Please contact us if you need help to build, review your current documentation or prepare new SOPs to implement a robust Quality  Management system that ensures high quality in your Clinical Research Center.




DATA CENTER CERTIFICATION
ECRIN-ERIC has a certification program of Data Centers for Clinical Research Units as part of the ECRIN quality services.
ECRIN Data Centre Certification is a process that identifies data centres providing high-quality, efficient and compliant data and information technology (IT) management for multinational clinical research. ECRIN strongly recommends the use of certified data centres for the multinational trials it supports.

Read more about Data Center Certification and contact your European Correspondent.