Clinical Trials Data Monitoring

At ICRS, our experienced team of Clinical Research Associates (CRAs) works in close collaboration with clinical trial management to ensure the success and efficiency of your trial. ICRS CRAs regularly monitor Investigator Initiated and Industry Sponsored clinical trials around the globe, from study start-up to closeout. With a focus on early identification and rapid resolution of issues and incorporation of Risk-Based Quality Data Monitoring, ICRS works to ensure the highest quality review of data and effective interaction with study sites.

Our CRAs conduct centralized and on-site clinical trials data monitoring visits throughout the study to:

• Ensure adequate protection of the rights of human subjects and the safety of all subjects involved in the clinical trial
• Assess investigator compliance with the protocol and regulations
• Identify any deviations from the clinical study plan
• Review source documentation and case report forms for accuracy, completeness, and timeliness
• Resolve data queries
• Conduct interim analyses as requested by clients
• Prepare study sites and sponsors for FDA inspections that may occur during or after the course of the clinical study

Quality Data Monitoring

We develop quality clinical trials data monitoring plans that incorporate the principles of Risk-Based Monitoring, including real-time analysis of data and risk indicators. Our comprehensive monitoring plans also address the trial complexity and sponsor requirements, often combining traditional monitoring visits with robust site management and remote monitoring tactics. This combination not only helps mitigate risk to data integrity by allowing for more efficient on-site monitoring, it also works to improve data quality, reduce investigator burden, and accelerate database lock.

Let ICRS provide customized and cost-effective monitoring for your clinical trial!