Regulatory compliance and patient safety are not just your priorities, they’re ours, too.
Protecting the rights of patients
Our clinical research associates have experience working in dialysis facilities, understand the needs and care of renal patients and are committed to patient protection in clinical trials. Our CRAs have direct access to more patient information, leading to a higher level of data quality review. Our CRAs will:
- Confirm patient eligibility
- Verify patient informed consent and compliance
- Manage reporting of adverse events
- See what other monitors don’t
Frenova’s clinical research associates understand the complexities of renal research and provide an on-the-ground team to ensure the integrity, safety and compliance of your study.
Verifying protocol and regulatory compliance
Our team 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
No other clinical development services provider has a more intimate understanding of patients and caregivers affected by kidney disease and its comorbid conditions than Frenova.