With quality assurance central to any study, the independent Quality Assurance (QA) Department is centrally organised at CRS-Andernach and is responsible throughout the CRS.
The QA manager has extensive supervisory responsibilities for any project at CRS and reports directly to the company's President and CEO. He works independently of all other personnel conducting the study.
The QA Department is responsible for:
- Managing the standard operating procedures (SOPs) system by appraising SOPs and study-specific procedures for compliance with international quality standards, governing the design, performance, recording and reporting of clinical trials (ICH guidelines); assisting functional managers and CRS staff in the development of SOPs; approving all SOPs and monitoring the development, approval, periodic review, revision, version control and archiving of all SOPs,
- Performing internal audits of clinical trials (site audits and in-house audits); performing audits during clinical studies according to GCP & GMP and the respective legal requirements, including audits during planning (study protocol and related documents), performance (e.g. management, measurements, sample collection and handling) and reporting (study report),
- Conducting system audits in-house and at external clinical sites; vendor qualification function of other external providers
- Preparing inspections by sponsors and regulatory authorities; representing CRS vis-à-vis external organisations including the FDA, sponsors and other organisations; serving as a primary contact during all audits and generating responses to audit reports.
Carried out separately from the Quality Assurance Department, Quality Control (QC) is performed during every stage of data-handling in all departments. It covers all essential procedures such as Clinical Realisation, Clinical Data Management (CDM) and Medical Writing.
Example: Study data are a part of multiple quality control reviews, which means that each CRF (case report form) file is thoroughly checked by the QC team to ensure the accuracy, consistency and protocol adherence of the data prior to release to CDM.