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Definition according to GCP
A systematic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data were
recorded, analyzed and accurately reported according to the protocol, sponsor's standard
operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).
Our service
- study process audit
- study document audit
- general system audit
For more information please contact our
Quality Assurance Manager Dr. med. Udo Romberg. |
