We have a dedicated Quality Assurance Department to ensure that your projects will receive the highest level of quality and continuous improvement by implementing Quality Management Systems. Our Quality Assurance Department is equipped with comprehensive set of standard operating procedures. Our team maintains an optimal level of knowledge through continuous education and training. Our quality assurance team has competency of predicting and preventing all non compliance at the early stages of development to ensure data integrity and accuracy. Our quality management team have approach to implement the quality management system by understanding the need for required compliance as per regulatory requirement.
This department is completely independent and provide the support to project teams to conduct high quality clinical research. They have all required technical expertise to ensure that the appropriate quality systems are in place to provide utmost data quality and integrity in accordance with ICH GCP, Protocol, SOP and regulatory requirement. Our quality management team also performs internal audits coupled with site audit to ensure compliance with ICH GCP, Protocol, SOP and regulatory requirement.
We are specialized in managing following quality assurance activities during entire project management cycle:
1. Management of The Quality Systems
2. Conduct and Reporting of Internal and on Site Audits
3. Vendor Qualifications
4. Conduct and Reporting of Mock Regulatory Onsite Inspections
5. Investigator Training for Management of Inspections by Regulatory Agencies
6. SOP Preparation
7. CAPA Implementation and Compliance