Critical to a successful clinical trial is the efficient management and monitoring of clinical sites. Pharsh Pharma has an exceptional track record in risk-based clinical trial monitoring that ensures scientific excellence and data integrity across all sites.

Pharsh Pharma engages a diverse range of specialised people to perform all aspects of site management and monitoring throughout our operational regional hubs.

Our regional clinical research associates (CRAs) focus on developing strong site relationships while ensuring adherence to data quality, subject safety, and early issue resolution throughout the course of the trial. Comprehensive monitoring plans are crafted to address trial complexity and sponsor requirements, and often combine traditional monitoring visits with robust site management and remote monitoring tactics.

Clinical Trial Monitoring activities include:

• Full service monitor visits – qualification, initiation, routine, and close-out
• Comprehensive monitor plans
• In country expertise for feasibility or regulatory submissions
• Thorough review of site records
• Timely completion of visit reports
• Quality review of monitor reports
• Source document verification as per monitor plans
• Rapid query resolution
• Site training and support
• Site management support and documentation
• Periodic remote EDC review
• Drug accountability
• Co-monitoring

Risk-Based Monitoring

Pharsh Pharma has taken a leadership role in the application of risk-based monitoring, the streamlined approach to monitoring clinical trials increasingly preferred by regulatory bodies. Pharsh Pharma’s application of risk-based monitoring has seen our sponsors receive higher quality data at a lower cost. The results generated by Pharsh Pharma are delivered in a timely fashion due to the centralization of information. The multi-site comparisons and centralized data collection allows for the identification of outliers, the early identification of risks and the immediate resolution of site issues.

Some of our clinical site management services include:

• Site selection and feasibility
• Development of recruitment criteria
• Managing patient recruitment
• Inbuilt quality assurance mechanisms
• Assurance of Good Clinical Practice (GCP)
• Communication with sites
• Customizable training based on the needs of the study
• Managing of local ethics review processes