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Quality Guarantee

Vasile Astarastoaie
The Quality Assurance system guarantees that the studies and the data recording are performed in compliance with the harmonized European legislation (ICH), respecting the Good Clinical Practice and Good Laboratory Practice guidelines and the Helsinki Declaration.

The elaboration and revision of standard operating procedures are in accordance with the quality assurance system. A number of over 60 standard operating procedure are followed when clinical studies are performed withinof the Center for Drug Evaluation.

The Quality Assurance system guarantees:
  • Compliance with Clinical Study Protocol and Standard Operation Procedures;
  • Assistance in implementing regulatory requirements, comprehension of and compliance with guidelines;
  • Permanent staff training;
  • Periodical audit of every structure involved and inspection preparation;
  • Qualification/validation of all the working systems:
    • equipment and devices;
    • (bio)analytical methods;
    • bio-statistical system.
  • Error Prevention.
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