Quality Assurance

At WEF Clinical, our QA team is committed to excellence, ensuring that all our teams consistently perform at the highest standards. We leverage this expertise to provide comprehensive quality assurance services, helping clients develop or update their quality systems and procedures, and conducting third-party audits.

Our QA team is composed of professionals with extensive experience in clinical research and in-depth knowledge of GCP guidelines and regulations. We are also well-versed in IT quality compliance and applying a robust Agile methodology for software development and validation.

Our Service Offerings Include:

• System Audits: Evaluating SOPs, processes, and staff training.
• Clinical Site Audits: Ensuring compliance and quality at clinical sites.
• Trial Master File Audits: Reviewing essential documents for completeness and accuracy.
• Protocol and ICF Audits: Ensuring protocols and informed consent forms meet regulatory standards.
• Clinical Study Document Audits: Verifying the accuracy and compliance of study documents.
• Clinical Database Audits: Ensuring data integrity within clinical databases.
• Laboratory Audits: Assessing lab practices and compliance.
• Vendor Audits: Evaluating third-party vendors for adherence to quality standards.
• Regulatory Inspection Support: Assisting clients in preparing for inspections by regulatory bodies.
• GCP Training Services: Providing comprehensive training on Good Clinical Practice.

Our mission is to ensure that every aspect of your clinical research meets the highest standards of quality and regulatory compliance.