Rho Federal Systems Division, Inc.
Rho is a global contract research organization (CRO) dedicated to advancing science, improving patient outcomes, and bringing new treatments to market through collaborative and innovative clinical development services. With over 40 years of experience, Rho emphasizes connection, scientific rigor, and a culture of cohesion to deliver smarter, more efficient clinical trials across various therapeutic areas and phases. The company provides comprehensive services including clinical delivery, project management, operations monitoring, risk-based quality management, pharmacovigilance, biometrics, biostatistics, statistical programming, regulatory strategy, and quality assurance. Rho also offers expertise in protocol development, analytical method validation, and regulatory consulting, supporting all phases of drug development and registration. Recognized for its leadership, innovation, and workplace excellence, Rho has received numerous awards such as the Best Places to Work, CRO Leadership Awards, and industry recognitions for growth and operational excellence. The company actively contributes to industry insights through blogs and publications on topics like clinical protocol development, data standardization, regulatory strategies, and analytical methods, demonstrating its commitment to advancing clinical research standards and practices.
Industries
Nr. of Employees
large (251-1000)
Rho Federal Systems Division, Inc.
Products
Interactive safety monitoring visualization suite
Configurable interactive charts and linked tables for safety surveillance (adverse event explorer, timelines, histograms, outlier trackers, shift plots) that accept CDISC-formatted inputs and enable drill-down to subject-level records.
Open-source axis automation macro for statistical graphics
Macro to automatically compute chart axis ranges and tick marks from input data to standardize axis configuration and reduce manual adjustments.
Reusable web-based data visualization library
Reusable charting library for building interactive clinical data visualizations and dashboards for web deployment.
Interactive safety monitoring visualization suite
Configurable interactive charts and linked tables for safety surveillance (adverse event explorer, timelines, histograms, outlier trackers, shift plots) that accept CDISC-formatted inputs and enable drill-down to subject-level records.
Open-source axis automation macro for statistical graphics
Macro to automatically compute chart axis ranges and tick marks from input data to standardize axis configuration and reduce manual adjustments.
Reusable web-based data visualization library
Reusable charting library for building interactive clinical data visualizations and dashboards for web deployment.
Services
Full-service clinical trial execution
Operational management of trials across phases and geographies, including startup, monitoring, safety oversight, and closeout.
Biometrics services (biostatistics, statistical programming, data management)
Statistical planning, analysis, programming for ADaM/SDTM, and clinical data management with emphasis on traceability and submission readiness.
Regulatory strategy and submission support
Design of regulatory pathways, preparation of marketing applications and meeting materials, and submission publishing across regions.
Pharmacovigilance and medical monitoring
Safety surveillance, adverse event reporting, safety signal assessment, and support for safety monitoring committees.
Quality assurance and risk-based oversight
QA systems, audits, and risk-based monitoring programs to ensure GCP and regulatory compliance throughout study conduct.
Decentralized trial planning and operationalization
Protocol planning and operational workflows for hybrid and decentralized trials, including vendor coordination for telehealth and home health services.
Full-service clinical trial execution
Operational management of trials across phases and geographies, including startup, monitoring, safety oversight, and closeout.
Biometrics services (biostatistics, statistical programming, data management)
Statistical planning, analysis, programming for ADaM/SDTM, and clinical data management with emphasis on traceability and submission readiness.
Regulatory strategy and submission support
Design of regulatory pathways, preparation of marketing applications and meeting materials, and submission publishing across regions.
Pharmacovigilance and medical monitoring
Safety surveillance, adverse event reporting, safety signal assessment, and support for safety monitoring committees.
Quality assurance and risk-based oversight
QA systems, audits, and risk-based monitoring programs to ensure GCP and regulatory compliance throughout study conduct.
Decentralized trial planning and operationalization
Protocol planning and operational workflows for hybrid and decentralized trials, including vendor coordination for telehealth and home health services.
Expertise Areas
- Clinical trial management and monitoring
- Protocol and synopsis authoring with integrated product planning
- Biostatistics and statistical programming
- Statistical analysis planning and interim analysis
Key Technologies
- CDISC standards (SDTM, ADaM)
- Statistical programming
- Interactive data visualization dashboards
- ePRO and electronic data capture systems