Regulatory compliance is not just your priority, it’s ours, too.
Our clinical research associates are experienced working in dialysis facilities and understand the care of patients living with ESRD. This level of awareness helps ensure sites are fully engaged from the onset to meet expectations all the way to study close-out. Choose the team that will deliver. Our CRAs will:
- Confirm patient eligibility
- Verify patient informed consent and compliance
- Manage reporting of adverse events
- Identify issues that inexperienced CRAs cannot
Frenova’s clinical research associates understand the complexities of renal research and provide an experienced team to ensure the integrity, safety and compliance of your study.
Verifying protocol and regulatory compliance
Our team provides comprehensive document management to verify your research study is meeting the highest standards of conduct and is prepared for meticulous inspection. Our CRAs will work closely with you and the sites to:
- Develop study procedures
- Review training and source documents
- Monitor regulatory compliance
- Verify regulatory documentation is maintained
- Audit eTMFs and sites
Through investigations and interventions for a clinical study managed by another CRO with poor monitoring, Frenova raised the level of quality, finances, efficiency, and human resource management.
No other clinical development services provider has a more intimate understanding of patients affected by kidney disease and its comorbid conditions than we do.