Services

Quality Management

 

CCDRD AG developed its quality management system based on the requirements of the ICH Guideline for Good Clinical Practice. Standard Operating Procedures (SOPs) are maintained covering all aspects of preparation, management, monitoring, evaluation and reporting of clinical trials – including archiving of trial-related documents.

 

Besides maintenance of CCDRD’s SOP system the following overall tasks belong to the responsibilities of QMD: defining the training schedule for CCDRD’s staff and maintenance of the personal training files, evaluation and approval of subcontractors, conducting external and internal audits, deviation and change management, addressing and tracking of corrective and preventive actions.

 

All essential documents generated in the course of a clinical trial such as clinical study protocol, information for subjects and informed consent, case report forms as well as the clinical study report including the whole set of appendices such as pharmacokinetic, statistical and analytical report are checked thoroughly in order to ensure the validity and proper documentation of study results.