Optimal Control & Flexibility
RTSM Web Applications
PAREXEL Informatics™ offers flexible web applications to empower study teams with active control and oversight of their RTSM (Randomization and Trial Supply Management) operations. As part of the ClinPhone® RTSM solution, Supplies Administration, Site Management, Inventory Management for Site Users and Notification Viewer are web-based tools with extended functionality to place increased administrative and management control in the hands of study teams. Through intuitive interfaces, the applications enable study leaders, supply teams, CRAs and site-based users to efficiently perform a comprehensive range of supplies and site management activities.
The Supplies Administration tool provides clinical supply teams with an enhanced ability to control and manage their trial supplies including inventory release, expiration date management, supplies transfer and qualified person (QP) release. Through the Supplies Administration tool, users can manually transfer stock between depots or sites, override pack status and change supply strategies through an intuitive interface. The ability to tightly control supplies and rapidly respond to emerging situations helps supply personnel overcome any challenges experienced in the supply chain. In particular, the application can be valuable for studies with plans for mid-study drug production or adding more countries, and resolve medication expiration or stability issues
• Expiration date management for site and depot supplies
• Transfer of supplies between depots and/or sites
• Supply strategy adjustments including adoption of new strategies
• Management of QP release and inventory release processes
• Management of supplies status across the entire supply chain
• Take direct actions to ensure smooth day-to-day running of study sites and site-related supplies across the globe
• Optimal user experiences enabled through an intuitive interface delivering highly targeted and relevant information
• “Click and go” interface for maximum efficiency in implementation
• Filter and sort by any column in the table to rapidly locate the item of interest
• Available in all languages used by IWR
• Allows users to play a proactive role in supply management and make optimal use of study supplies
• Ability to rapidly respond to urgent situations where medication needs to be immediately withdrawn, replaced or transferred
• Total visibility into QP release status to enhance management of this complex process across multiple countries
The Site Management tool allows study personnel to view site-level status in real-time and take appropriate actions pertaining to their sites. By exposing the full site management functionality to study teams through a convenient web application, it enables proactive monitoring and effective oversight of study sites throughout the entire trial process.
Key Features & Benefits
• Access to current site status as well as decision-support data regarding screening, randomization and supplies
• Change study configuration settings such as screening and/or randomization windows and limits
• Trigger activation, deactivation and reactivation of sites
• Open or close screening and/or randomization of sites
• Facilitates proactive monitoring and sound decision making based on accurate, real-time site status and performance information
Site Inventory Management
The Inventory Management tool provides study personnel with an instant view of the status of supplies related to their site. It makes the management of trial supplies at clinical sites much easier and enables efficiency when taking actions. These actions include the registration of supplies upon arrival, dealing with quarantine requirements, and handling damaged or missing medication.
Key Features & Benefits
• Access to current supplies status at site including both consignments/shipments and medication packs/kits
• Handles both individually numbered and non-numbered (open-label) supplies
• Register consignments/shipments on arrival at site and place into quarantine if required. Place individual packs/kits in-to quarantine or mark them as damaged or missing
• Improved management of site-level supplies through the use of accurate, real-time status information
The Notification Viewer allows users unprecedented access to their entire transaction confirmation history – removing the need for them to contact the PAREXEL® Customer Care team to get copies of notifications: saving them time.
• Powerful search facilities – locate the item you want quickly by searching within the subject line or body text across multiple studies and date ranges
• Secure environment which automatically complies with all blinding restrictions
• Print notifications or export as pdf
These web applications empower study teams to take a proactive role in their RTSM studies. By giving direct and increased control to the users, manual requests are eliminated, errors or delays are minimized, and ultimately the overall trial process is streamlined. Comprised of highly configurable and pre-validated components, these solutions provide our leading RTSM functionality to users through easy-to-use and intuitive web interfaces.