Quality AssuranceCCBR Clinical Research conducts all clinical trial activities in compliance with ICH/GCP guidelines, the Clinical Trial Directive, relevant local regulations and guidelines as well as the clinical trial specific requirements.
Additionally, CCBR has a team of Quality Assurance Auditors that regularly conduct internal audits as part of the CCBR Quality Management System. Internal audits are conducted according to internal audit plans that define the audit scope, required documentation, applicable SOPs and supporting documentation.
In the event that CCBR is audited by Sponsors and/or third parties and/or inspected by the Regulatory Authorities, an assigned CCBR Quality Assurance Auditor will assist the site, as needed.
On a day-to-day basis, the Central Quality Assurance personnel, and also the Local Quality personnel play an important role in every day quality aspects at the sites.
Current quality status:
- 25 - 30 Audits (Sponsors and/or third parties) per year
- FDA: 5 inspections so far resulting in blank FDA 483 Forms
- EMA: 3 inspections so far resulting in no significant findings
- Local Regulatory Authorities: 11 inspections so far resulting in no significant findings