While our mission is to set THE standard in on-site monitoring, we believe this is best accomplished with locally-based monitors. Our service region is limited so that we continue to maintain the quality, longstanding business relationships we have developed with each study center. 

Knowledge is key and we know this extends far beyond the protocol. We believe an understanding of local healthcare practices, site personnel, IRB policies, and institutional procedures all contribute to our success in setting THE standard!

• Complete on-site trial monitoring services including pre-study, initiation, routine monitoring and study closeout proceedings
• Emphasis on GCP
• Phase I-IV trials
• Extensive EDC experience with multiple vendors
• Contract/budget design and negotiation
• Site Identification services available
• Laptop use at all site visits
• Daily or hourly rates available

Pre-Study Site Evaluation

• Our local presence provides advantages when assessing facilities, equipment, protocol logistics, and site-staff workloads
• Versus the facility alone, we thoroughly review site processes, and the ability to effectively enroll subjects in a given protocol

Initiation

• Protocol-specific, detailed slide presentations emphasizing compliance
• We conduct an in-depth review of all protocol procedures, including laboratory, special procedures,  drug dispensing and accountability, and data transmission systems in conjunction and sponsor standard operating procedures

Routine Monitoring

• 100% source-data verification unless alternative plan outlined by Sponsor
• Thorough review of all source data and processes
• Post-visit discussion with investigator so study status is clearly communicated
• Feedback to sponsor of all trial-related issues