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Quality Assurance  
 

Quality Assurance (QA) is an independent function that reports to the top management. The goal of QA is to promote excellence by ensuring adherence to ICH – GCP and SOPs. The team ensures that the ethical conduct of the clinical study, documentation and reporting of the data is in compliance with ICH-GCP and regulatory guide lines.

The documentation is facilitated by use of checklists and forms for reporting observations and deviations. The QA team also prepares audit reports and compliance reports.

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 generated. The verification process is specified and justified with the in-house systems, procedures and applicable regulatory guidelines.

 
 
Role of Quality Assurance
 
CAPA management
Working with clinical operations to design and execute clinical trial oversight plans.
Working with clinical operations to ensure output of high quality trial data from clinical sites.
Assuring management about quality and practices of clinical trials at sites
 
SOPs
     
All SOPs are well define with all the system and the process to perform during the conduct of the clinical trail at Asiatic
SOPs have been audited by various sponsor companies from US and Europe
SOPs at Asiatic are reviewed, approved and controlled by Quality Assurance
 
Quality Assurance departments also play an important role in the protocol review procedure
 
The QA team ensures that the staff is trained periodically for the current regulatory guidelines for following the Good Clinical Practices.

Staff orientation is conducted regularly. Technical skills are enforced by attendance at conferences, workshops and seminars. All phases of internal and external training are documented and archived.
 
 
Quality Assurance Audit Program at Asiatic
 
Internal and external audit programs for systems, procedures and personnel records
Quality Assurance audits of documents and the raw data generated during the study
Quality Assurance audits of regulatory application and documents
Database audits to inspect the data cleaning process
Clinical site audits to evaluate site activity
Site preparation for anticipated sponsor or regulatory inspections
Central laboratory process audits to satisfy the requirements of accreditation
Audits of external vendors
Training
 
 
 
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