Trial Monitoring & QA

Assuring Quality and Accuracy

Monitoring clinical trials ensures the protection of human rights and the reliability of the data collection
process. Several types of systematic activities are utilized in the monitoring process so that each trial is
conducted according to study protocol and in compliance with Good Clinical Practice (GCP), institutional, state
and federal regulations.

Our experienced quality assurance team supports both industry sponsored and investigator-initiated clinical
trials through monitoring services including:

• Internal monitoring and quality assurance for both industry sponsored and investigator-initiated studies
• External monitoring of clinical trials at other institutional sites
• Quality assurance preparation for an external FDA, sponsor, or IRB audit
• Verifying adherence to current protocol based on sponsor requirements and regulations
• Evaluating research participant safety and data accuracy
• Generating detailed monitoring reports and communicating findings to the investigator
• Developing Standard Operating Procedures (SOPs) and Corrective and Preventative Action (CAPA) plans
• Providing training resources to study staff