Overview
A Dynamic Landscape Demands a Disciplined, Flexible CRO Partner Clinical trial management and monitoring must adapt with the new complexities which we are facing in modern clinical trials. By implementing quality risk management systems such as Risk Mitigation Plans and protocol evaluations, KYAMCH-BRS collaborates to maintain focus and flexibility with specific attention to the study objective, design, complexity, size and endpoints1. Striking the delicate balance between centralized and on-site monitoring needs, as well as careful consideration of targeted source data verification, our monitoring teams are equipped to readily facilitate the new dynamics of clinical research sites with a focus on precise and meaningful data.
Monitoring Strategies
KYAMCH-BRS implementing effective risk mitigation at study start is a focus for the CRA team. Multifunctional and communicative relationships across Clinical Operations serve as the backbone for CRAs, and the monitoring emphasis is rooted in subject safety, data integrity, and risk assessment. KYAMCH-BRS understand the study objectives, efficacy and safety variables, and the Lead CRA outlines how the CRA team should proactively identify and manage the study according to critical data and processes. With the oversight, support, and training from Clinical Trial Management, CRA teams use site quality indicators to emphasize patient safety and data integrity. We create a centralized monitoring plan review team within Clinical Monitoring so our approach is consistent, yet flexible enough for study-specific considerations and implementation. KYAMCH-BRS Mitigation Risk through Real-time Metrics, System and Process Efficiencies.
Clinical Monitoring Distinction
KYAMCH-BRS Clinical Monitoring focuses on global consistency, support, guidance, training and oversight. KYAMCH-BRS CRAs are dedicated to ensuring site compliance, risk mitigation, and building strong site staff relationships. Through our dedicated Clinical Monitoring model, including CRA recruitment and selection, initial and ongoing training, study and site resourcing, line management support and quality oversight, and continued development, KYAMCH-BRS CRAs provide unparalleled monitoring performance for all phases of today’s clinical research trials.
