Clinical Audit and Monitoring

It is of utmost importance to establish auditing processes and quality assurance at the beginning of a clinical study. Quality has to be built in at every step of clinical development process: right from designing of a protocol & case report forms to preparing and submission of reports.

We are known for our:

• Professional monitoring
• ICH – GCP compliant SOPs
• High quality data
• Detail oriented efficient monitoring
• Regular communication and feedback to the sponsor
• Experience in all phases ( I thru IV) of development including BA/BE/PK studies

Our ICH – GCP compliant standard operating procedures include

outlines and methods for all visit types including:

• Pre-investigational site visits (PISV)
• Site initiation visits (SIV)
• Site monitoring visits (SMV)
• Site closure visits (SCV)

Additional specialty services:

• Development of SOPs and STPs compliant with regulatory and other relevant guidelines through extensive review of literature
• Review of existing SOPs to ensure clinical effectiveness