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Quality Management Systems

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Overview

Tigermed QA Team is independent of clinical trial operations, composed of numerous experienced professionals. Its 3rd party’s perspective can help to assess the quality and risk of the clinical trial operation, data, statistics, vendors etc. QA Department is to guarantee the clients’ project with efficient clinical audit, comprehensive staff training, and perfect SOP management.

 

Building and Maintaining Quality Management Systems

Tigermed’s quality specialists can 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.

 

Auditing

  • 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

 

Training

  • Based on audit findings we provide training in specific areas to avoid similar findings
  • Organization, coordination and supervision of the Professional Skills training to CRAs and PMs