A New 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, Medpace 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.
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. CRAs 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, the Lead CRA and 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, even at a site by site level. Essential statistical monitoring and targeted centralized data review meetings are performed throughout the applicable time points of the study, respective of the risk level at that particular stage.
Risk Mitigation through Real-time Metrics, System and Process Efficiencies
Using a centralized monitoring approach as applicable, ClinTrak SM CTMS allows Medpace CRAs real-time access for focused data review with targeted action items based on a site quality indicator dashboard. Each CRA is equipped with the hands-on tools necessary to monitor through our proprietary software systems. These systems evolve with the changing needs of the end user for streamlining effective monitoring in a risk-based environment.
Clinical Monitoring Distinction
Medpace Clinical Monitoring focuses on global consistency, support, guidance, training and oversight. Medpace CRAs are dedicated to an average of two protocols at a time, so they channel all effort to process excellence, understanding the intricate issues of the protocol and indication (disease), ensuring site compliance, risk mitigation, and building strong site staff relationships.
We believe excellence in those areas are the hallmarks of a solid CRA team. 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, Medpace CRAs provide unparalleled monitoring performance for all phases of today’s clinical research trials.
- FDA. Guidance for industry: Oversight of clinical investigations – A risk-based approach to monitoring [August 2013 Procedural].
- Reference: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) [09November2016]