Do you know where your supplies need to be?
Automated Randomization and Trial Supply Management
The acceleration of clinical research often means that studies must start with short lead times and with limited trial supplies. Further, the increasing complexity and global nature of studies makes the logistics of maintaining medication supplies at each study site more difficult and labor-intensive.
PAREXEL Informatics™ provides automated randomization and logistics management for clinical trials through its ClinPhone® RTSM (Randomization and Trial Supply Management) solutions. Randomization and supply processes are controlled by a central computer accessed via telephone (Interactive Voice Response, IVR) and web (Interactive Web Response, IWR) interfaces.
Our sophisticated randomization and trial supply management algorithms are the subject of continued research and development to optimize medication supply chain processes and provide the greatest drug savings and the most robust inventory control.
• Leading provider of randomization and trial supply management services
• Extensive range of validated randomization methods
• Automated inventory control
• Dispensing and titration management
• Comprehensive management of adaptive trials
• Emergency code break
• Real-time study recruitment and supply location/status reporting
• Global coverage with 24/7/365toll-free availability
• 24/7 in-house support help desk
PAREXEL® is an experienced provider of an extensive range of validated randomization methods including:
• Static blocked randomization lists
• Minimization with biased coin assignment
• Zelen’s method
Our in-house team of experienced industry statisticians provides consulting expertise including:
• Advice on treatment allocation schemes
• Simulations for balance on stratification factors and predictability of randomization schemes
• Dynamic randomization methods
• Custom randomization algorithms
• Open label study considerations
Trial Supply Management
PAREXEL has developed unrivaled sophistication in our ability to deliver targeted and efficient trial supply management. Our team of internal specialists provides expert advice and knowledge regarding the optimal approaches for individual studies. Our services include:
• Automated site and depot medication inventory control
• Management of complex dispensing protocols including titration studies
• Consulting on optimal supply chain management and medication kit configuration
• Pooling medication supplies across multiple protocols
• Real-time reporting of patient progress, medication assignments, supply location and status
• Expiry date management
• Management of QP release
• Integrated with the ClinPhone Drug Accountability solution for full tracking of supplies from shipment to returns
Emergency Code Break
Our 24 hour emergency code break service ensures that treatment details can be accessed promptly via the telephone from any location worldwide.
PAREXEL is a leading provider of integrated solutions. The ClinPhone RTSM solutions can be integrated with our own and other leading EDC and CTMS software applications.