Our Clinical Monitoring department is driven by our seasoned staff of career Clinical Research Associates (CRAs). Rho CRAs bring vast clinical experience to each trial.
Our Clinical Monitoring department is driven by our seasoned staff of career Clinical Research Associates (CRAs). Rho CRAs bring vast clinical experience to each trial. Averaging over a decade of experience, many have graduate-level credentials and professional experience in life sciences gained before joining our team. Many of our CRAs have worked as RNs, LPNs, or MDs and have experience in the medical technology industry. Our CRAs have a practical knowledge of disease states and are provided training and educational components to maintain their knowledge base.
Rho's lead CRAs develop and manage highly functional monitoring teams. Our teams have been successful at identifying protocol, informed consent form, and site contract road blocks. We build strong relationships with site staff, working with them to resolve enrollment barriers. As clinical experts, they help manage study protocols while complying with regulatory requirements, industry guidelines, and standard operating procedures. At the same time, our CRAs work closely with the project's Clinical Data Management and Product Safety leads to ensure clinical data management and safety queries are addressed in a timely manner.
Our Clinical Monitoring capabilities include:
- Identification and selection of investigators
- Identification and management of central institutional review boards
- Regulatory document review and collection
- Site contract, budget negotiation, and grant administration
- On-site training
- Site qualification, initiation, and closeout
- Interim site monitoring
- Drug accountability
- Second clinical review
- Data query resolution