ClinPhone® RTSM

Perceptive Informatics provides automated randomization and supplies management through its ClinPhone RTSM (Randomization and Trial Supply Management) solution. Our services are offered by the industry's most experience and trusted provider of IVR (Interactive Voice Response) and IWR (Interactive Web Response) technologies.

As part of the ClinPhone RTSM suite, Perceptive offers flexible web applications to empower study teams with increased control to perform a comprehensive range of supplies and site management activities.

Randomization

Our experts understand that randomization is critical to the success of your trial. Our randomization methodologies and algorithms have been used in over 3,000 clinical trials, helping pharmaceutical sponsors to achieve treatment group balance, eliminate selection bias and limit the predictability of treatment allocations.

We support clients with a unique consultative service of unmatched quality designed to meet the specific needs of individual studies. With support from in-house statistical experts, you can choose from a vast selection of validated algorithms or work with the team to develop a custom algorithm to support your study design. Services include:

  • Comprehensive spectrum of validated randomization methods
  • Centralized emergency code break via IVR and IWR
  • Simulations and consulting to optimize the randomization methods
  • Real-time study recruitment reporting
  • Randomization methodologies for adaptive trial designs

Trial Supply Management

Our Trial Supply Management solution enables pharmaceutical sponsors to manage trial supplies more easily and efficiently by automating the restocking of sites and depots throughout the supply chain. Continued investment by Perceptive in research and development puts our Trial Supply Management solution at the forefront of delivery of advanced methods for solving difficult supply issues such as managing adaptive trial designs, titration regimens or medication pooling across multiple protocols.

Our dedicated team of supply chain specialists offer expert advice regarding optimal ways to put in place robust inventory control and solve your studies' medication management challenges. Services include:

  • Automated site and depot medication inventory control
  • Real-time reporting of patient progress, medication assignments, supply location and status
  • Unique supply algorithms to optimize efficient use of available supplies and provide unbeatable blinding measures – particularly valuable where expiration dates are an important factor in your trial
  • Expiration date management and relabeling at depots and sites
  • Pack-type substitution and multi-pack "box" handling within shipments
  • Trial supply management for adaptive designs
  • Integration with the ClinPhone® Drug Accountability solution for full tracking of supplies from shipment to returns

RTSM Web Applications

As part of the ClinPhone RTSM solution, our web-based tools provide extended functionality and place increased administrative and management control in the hands of study teams.

Supplies Administration

The Supplies Administration tool provides clinical supply teams with an enhanced ability to control and manage their trial supplies including inventory release, expiry date management, supplies transfer and qualified person (QP) release. Key features include:

  • Expiry 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

Site Management

The Site Management tool allows study personnel to view site-level status in real-time and take appropriate actions pertaining to their sites. Key features include:

  • 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

Site Inventory Management *NEW*

With our new Site Inventory Management tool, site users can see the status of their supplies much more easily and take actions more efficiently than ever before. Key features include:

  • Instant overview of supplies at the site: find out “what’s in transit, available for use, or currently in quarantine?”
  • Register the arrival of multiple consignments at once, marking all supplies as available, damaged or quarantined
  • Mark multiple medication packs as damaged or missing with a few simple clicks
  • Filter and sort by any column in the table to rapidly locate the consignment or pack of interest
  • Multi-lingual capability according to IWR language requirements

See Also:

  • ClinPhone Compact to find out if your study can benefit from our ready-made solution for quick, easy and cost-effective RTSM
  • ClinPhone MedSim to learn about how you can realize cost savings by accurately estimating supply needs
  • ClinPhone Drug Accountability to explore how Perceptive’s solution can be used to manage the entire accountability, reconciliation, returns and destruction process
  • RTSM Reporting to see how you can answer key questions through intelligent analysis and presentation of your study's RTSM data
  • Perceptive MyTrials Overview to discover how the combination of our products brings increased value and utility to your studies