Quality Assurance

Encode is committed to providing high quality services and ensuring compliance of its operations with regulatory requirements and international guidelines (International Conference on Harmonisation’s Good Clinical Practice Guideline). This is achieved through application of standard operating procedures governing every principal activity, training, monitoring and audits.

The responsibilities of Encode's Quality Assurance unit include:

• Development, review and maintenance of Encode’s procedural documents (standard operating procedures, etc.)
• Review/audit of clinical trial authorisation application dossiers and study documents for compliance with applicable regulations, guidelines and standard operating procedures, e.g.
• study protocols
• case report forms
• informed consent forms
• source data worksheets
• clinical study reports
• Performing audits at investigator sites, laboratories and pharmacies
• Internal audits and compliance assessments
• Vendor audits
• ICH GCP training
• Providing consultation and feedback to Encode management and employees for regulatory compliance and process improvement
• Serving as contact for external audits and regulatory inspections