Quality Assurance

Reliable data are the basis for any decision during product development and approval phase. Therefore INAMED established a Quality Management System which will safeguard the highest quality standards, throughout the entire clinical trial from protocol development up to the final study report. All state-of-the-art procedures and demands of international regulatory authorities, e.g. EMA and the FDA, are followed.

Thorough training and regular quality control ensure that the members of the study team fulfill all their obligations in accordance with regulatory, guideline and normative provisions and the SOPs of Inamed, in particular with the requirements of ICH-GCP. Amongst other measures, this is ensured by conducting internal pre-study kick-off meetings involving the entire study team and by developing and training of study specific working instructions.

Our Quality Assurance Unit is also responsible for the quality management system and conducts internal company systems and project audits as well as vendor audits to ensure that vendors work to the same high quality standards.

Regular audits by external, independent 3rd parties and inspections by regulatory bodies and sponsors ensure the high quality standard is kept and continuously improved.

The team has extensive experience and routinely conducts GCP, Vendor, Study Specific, Site, TMF, Database / Data Management, and Clinical Study Report Audits.

Study Specific Audits
• Clinical Study Protocol Audit
• PIS/ICF Audit
• e(CRF) Design Audit
• Investigator Site Audit
• Trial Master File Audit
• Database/ Data Management Audit
• Statistics/TFLs Audit
• Clinical Study Report Audit

Vendor Audits
• Full Service CRO Audit
• Phase 1 Unit Audit
• Data Management and Statistics
• Archives
• IT/CSV
• Clinical Laboratories
• IMP Manufacturers
• Wholesale Distributors
• Translation Agencies

Other Services
• Mock GCP inspection
• System/process audits
• GCP training
• QMS support/ review/ admin
• Study documents QC/ review
• CSV documents – QA review
• Auditor training