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QC/QA

A clinical trial is under continuous evaluation and verification by Quality Control (QC) group in order to ensure compliance with Good Clinical Practice, the Pharmaceutical Affairs Law and Protocol. At the same time, an audit is conducted on a clinical trial as part of Quality Assurance (QA) to maintain reliability of a clinical trial.

QC activities
1. Preparation of Standard Operating Procedures for QC
2. Verification of activities and documents for requesting investigation at sites, contracting and completion of a clinical trial
3. Verification of activities and documents for collection, evaluation, and communication of safety information
4. Verification of activities and documents for control of investigational drug
5. Verification of activities and documents for handling of clinical data such as Case Report Forms
6. Verification of monitoring reports
7. Verification of contents of Clinical Study Report
8. Proper Storage of records of all activities mentioned above

QA activities
1.System audit
2. Audit of an investigational site
3.Internal audit on contract monitoring
4. Sending an auditor to a sponsor
5. Consultation on quality assurance system
6.Preparation of audit SOP/check list