Asiatic is committed to provide quality service in all aspects of the clinical trial. We have a dedicated QA team that is functionally independent and yet forms an integral part of our operations.

This independent team consists of experienced professionals and directly reports to the management. The team ensures that the ethical conduct of the clinical study, documentation and reporting of the data in compliance with ICH-GCP guide lines.

The documentation is facilitated by methods such as use of checklists and forms, details of action taken, dates the individuals responsibilities etc. The team assures that all observations and findings are verified for the credibility of the data and that the conclusions presented are correctly derived from the raw data. The verification process is specified and justified.

SOPs

We have developed our own SOPs in consultation with Research Resources Inc from the US. Our SOPs have been whetted by sponsors from the US and Europe.

The SOPs find their application in the following Area:

• Document control
• Training
• Quality Assurance procedures for different areas
• Safety criteria
• Internal quality control, etc.

The QA Audit Program Involves:

• Internal audits of Asiatic 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 Asiatic monitoring process
• Site preparation for anticipated sponsor or inspections
• Central laboratory process audits to satisfy the requirements of accreditation
• Audits of external vendors

Training

• Staff orientation is conducted regularly, wherein they are taught theoretical as well as practical skills. Technical skills are enforced by attendance at conferences, workshops and seminars. All phases of internal and external training are documented and archived.