Monitoring

At CRA Solutions, we use the MRM Step Method to ensure high quality monitoring. The MRM Step Method is a systematic approach to monitor training that encourages critical thinking and thorough documentation. We understand that experience alone is not enough to guarantee effective monitoring, so we provide our CRAs with the tools, training, assessments, and support that they need to succeed. We offer risk-based monitoring with rapid turnarounds to meet your deadlines. Our leadership also has experience with eSource in combination with EDC. This is critical in developing an FDA compliant eSource clinical monitoring plan. We also offer monitoring oversight services and performance assessments.

Both ICH GCP, ISO 14155:2019 and federal regulations recognize the monitor’s key role in ensuring the quality and safety of clinical research. With our extensive experience in clinical trial rescue and Corrective Action Preventative Action (CAPA) plans, we have identified several common causes of inadequate monitoring that can lead to costly delays and deficiencies in a clinical trial:

• Inexperienced Project Managers
• Lack of an organized process for selecting and qualifying of monitors
• Inadequate training, mentoring and performance assessments
• Lack of standardized monitoring systems, tools, and problem-solving strategies
• Lack of therapeutic area training