Quality Assurance

iGATE Clinical Research has an independent quality assurance team that performs the following functions:

Roles of the Quality Assurance Team:

• SOP management: The quality assurance group develops, reviews and updates our standard operating procedures (SOPs) to ensure compliance with current regulatory standards and for continuous quality improvement purposes
• Development of training programs to ensure employees are trained on the company processes and applicable regulatory standards and guidelines. GCP training of investigator teams and at investigator meetings is done as required
• Internal audits: Our quality assurance group conducts independent audits to evaluate compliance with applicable standard operating procedures and regulatory requirements. Audits may be performed at various stages of project conduct in order to facilitate appropriate intervention and preventive or corrective actions as required

The QA Audit Program Involves:

• Internal audits of iGATE CR procedures, systems and personnel records
• Quality assurance audits of study documents
• Quality assurance audits of regulatory application documents
• Database audits to inspect the data cleaning process
• Clinical site audits to evaluate site activity and the iGATE CR monitoring process
• Site preparation for anticipated sponsor or FDA inspections
• Central laboratory process audits to satisfy the requirements of accreditation
• Audits of external vendors