CRA Solutions maintains that monitoring is a function of auditing. Our CRAs are trained to use the MRM Step Monitoring Method™ tools to standardize monitoring across all subjects and to secure GCP compliance using Corrective Action Preventative Action (CAPA) Plans.
Most non-compliance is attributable to lack of training and preparation, so in order to minimize the potential for non-compliance, CRA Solutions performs protocol feasibility assessments and source document gap analysis prior to trial initiation. The source document gap analysis allows us to identify “at risk” (data that is not part of standard medical documentation practices) and prepare sites to conduct a successful trial.
CRA Solutions partner Medical Research Management (MRM) provides monitors with training and expertise, including study specific competency and core knowledge assessments. Our CRAs are selected from the MRM 140 Hour CRA Certificate Program and the Advanced Quality Monitoring seminar. CRAs are tested for competency, core knowledge, and thorough understanding of FDA/ICH GCP. CRA Solutions, Inc. manages the MRM CRA Fellowship Program™, offering a cost-effective solution to the clinical research budget.