Clinical Trial Monitoring

TKL offers an experienced team of regionally based monitors, all with more than 5 years of clinical trial monitoring experience. Our clinical research associates (CRAs) are focused on early identification and rapid resolution of issues. TKL’s historical turnover rate for CRAs is half the industry average, delivering continuity and stable teams for your projects resulting in higher quality and lower query rates.

Clinical Trial Monitoring activities include:

• Focused attention on identifying and escalating adverse-event (AE) issues
• On-time comprehensive trip reports
• Quality Control (QC) visits and on-going formal training programs
• Prestudy site evaluation/investigator assessments
• Comprehensive monitoring plans
• Site initiation, interim monitoring and closeout visits
• 100% source document to Case Report Form (CRF) review
• Drug/device accountability
• Co-monitoring