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Rho
RAND™
, an interactive voice response (IVR) and/or Web user interface, is a Sponsor-customized randomization, patient diary, and notification system that leverages state-of-the-art technology for managing clinical trials.Rho
RAND™
is a fully validated framework that allows the rapid development of study-specific applications. Rho
RAND™
provides 24-hour, 7 day-a-week multilingual central randomization across multiple clinical studies.
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Key Functions
- Subject enrollment and screening
- Randomization
- Drug assignment
- Diary entry and assessments
- Investigator notification
- Emergency code break
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Medication and inventory management
- Request initial study kits with automatic generation of shipment requests when site inventories are low
- Confirm receipt and condition of study kits, simplifying damaged kit documentation
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Key Features
- Programming tailored to individual trial needs
- Multiple randomization algorithms, including adaptive procedures for dynamic allocation of treatment assignments
- Rapid system updates for instantaneous changes in dose tiers and sample sizes
- Event-triggered administrator alerts
- Blinded and unblinded fax, email, and digital pager notification to multiple recipients
- Real-time reports
- Full software validation in compliance with FDA 21 CFR Part 11 regulations
- Secure user authentication and verification of subject eligibility
- Dedicated, secure server hardware and remote network backup
- Trial data is protected in a highly resilient primary server site and remote disaster recovery site hosted and supported by Rho
- Detailed audit trail and transaction logging
- International toll-free access
- Support for most languages in the Americas and Western Europe
- Successful implementation in multinational studies
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Services
- Preparation of trial-specific manuals and worksheets
- Participation in system training sessions
- Multilingual Help Desk
- 24/7/365 support team
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Benefits
- Dual access through user-friendly phone and Web user interfaces allows users to choose their preferred method to access the system
- Reduce time spent managing medication shipments. With Rho's automatically generated shipment request forms and drug receipt confirmation procedures, managing large inventories and shipments becomes a simple task
- Built-in security features ensure randomization database is secure
- Rho's primary and disaster recovery server sites keep your system running in the event of power failure
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