Clinical Trials are subject to a broad spectrum of quality requirements including aspects like distribution, labelling, packaging, and release by a Qualified Person.Tigermed’s QA department supports you in ensuring the quality and integrity of a trial and the reliability of implemented systems. Because there are often different third parties involved, our quality experts also help to mitigate the quality and risk of vendors to your clinical trial operations by providing audits, comprehensive staff training, and accurate SOP management.
Building and maintaining Quality Management Systems
Tigermed’s quality specialists help you set up, design, and/or improve your Quality Management System (QMS), providing your clinical development with a solid structure in terms of Standard Operating Procedures (SOP), processes and resources that allow you to streamline your clinical trials and cost-effectively mitigate potential quality issues. It is their vast clinical experience that enables our clients to identify and prevent issues that might otherwise turn into major bottlenecks at a later stage.
? Provide the clinical trial audit and system audit, ensure clinical trial operations validity and GCP compliance with GCP, Tigermed’s SOPs, and relevant regulations
? Distribute the audit report to auditors and suggest the auditor to reply with corrective and preventive actions for QA review
? Based on audit findings weprovidetraining in specific areas to avoid similar findings
? Organization, coordination and supervision of the Professional Skills training to CRAs and PMs