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Rho has a dynamic and experienced employee-based clinical monitoring group with vast therapeutic experience. Our clinical professionals are fully committed to quality and provide unsurpassed clinical monitoring and site management services. Regionally located CRAs provide additional flexibility and region-specific expertise while reducing travel time. We focus on subject safety and data quality.
Unlike our larger competitors, we provide personalized clinical services and maintain a very low turnover rate. Our monitoring teams build trusting relationships with assigned sites through effective communication, training, organization, and adherence with GCP and regulatory standards.
Our clinical staff works seamlessly with Rho's data management group, as well as external data management groups, to ensure the highest possible data quality throughout the study. Frequent, open communication between clinical operations and data management staff regarding all data management processes, including CRF design, edit check development, and query development, produces key quality control measures throughout the life of the project.
Our services are comprehensive and include:
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Clinical Monitoring
- Investigator identification and selection
- Identification and management of central laboratories
- Identification and management of central IRBs
- Regulatory document review and collection
- Site contract, budget negotiation, grant administration
- On-site training
- Site qualification, initiation, closeout
- Interim site monitoring
- Drug accountability
- Second clinical review
- Data query resolution
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Documentation Development
- Study reference manuals
- Site regulatory binder preparation
- Regulatory document collection plan
- Informed consent development (Regulatory Affairs)
- Clinical monitoring plan
- Source document development
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Investigator Meetings
- Preparation
- Management
- Presentations
- Training
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Clinical Project Management
- Proactive management approach
- Open, honest communication
- Sponsor/CRO team meetings
- Ongoing study tracking and reporting to client
- Verify that all goals and timelines are strategically managed to meet or exceed expected results
- Delivery of on-time projects
- Safety System
- Clinical Trial Management System (CTMS)
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Education, experience, and thorough training are all part of Rho's equation for quality clinical operations services. Every CRA participates in a rigorous project-specific training program before the start of each new trial, as well as comprehensive CRA training at the start of their employment at Rho. Continuing education is a vibrant aspect of our corporate culture, resulting in nearly half of our CRAs having completed a postgraduate degree. Our therapeutic experience includes:
- Infectious Disease
- Autoimmune Disease
- Respiratory Disease
- Virology (HIV)
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- CNS (epilepsy, stroke, traumatic brain injury, ADHD, memory loss, and neuropathic pain)
- Cardiovascular
- Gastrointestinal
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- Psychiatric
- Oncology
- Hematology
- Anti-fungal
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