Web-based Randomization System

Home Web-based Randomization System

Central randomization of patients is an important attribute of multi-centre clinical trials. MFPL has developed and implemented a computerized, web-based randomization service. MFPL’s IWRS software is yet another powerful and valuable asset in our toolkit that enables sponsors to not only configure subject enrolment and randomization process but also manage global IP supply chains, using an intuitive web-browser interface. This service permits patient randomization into one of two or more treatment arms at any time without incurring the need for personnel continuously present at the central site at all times.

Our IWRS is Easy to Use. The Randomizer is accessible anytime,

anywhere and via any device that has a modern web browser and is connected to the Internet. Site randomize subjects with only a few clicks and are immediately notified of the treatment allocation.

The system is Comprehensive which fully support open and double-blinded trials. It provides a customizable role-based access control, email notifications and built-in reporting functions. For statisticians, the Randomizer provides a simulation tool which can be used to test a trial design or to generate randomization lists.

All transactions are Secure & Validated with audit trail and the list of randomizations can be downloaded and analyzed at any time by authorized users. Our Interactive Response Technology (IRT), covers IWRS which is a full-fledged Randomization and IP Supply Management solution that tracks your product throughout the entire clinical trial (including dispensing). The system serves a dual purpose. First, it eliminates selection-bias and limits the predictability of treatment allocation and enables treatment group balance. Second, it optimizes clinical supplies management and inventory tracking ensuring that right investigational products are available and assigned to the right subject at the right time. The IWRS can be used in any type of clinical trial, including medical devices. It is a cost-effective alternative that can be used independently of your EDC. The IWRS can also integrate with other systems automatically (including our EDC System, allowing you to use the tool independently while maintaining a communication with an external vendor’s tool.

Key features:

  • Performs the core function of patient registration, enrolment, and randomization.
  • Implement complex randomization methodologies using validated randomization sequences.
  • Define randomization blocks across various strata; adjust cohorts, and of course, maintain the study blind.
  • Algorithm-based subject medication dosing and dispensation.
  • Perform inventory management, drug accountability, and drug reconciliation under one roof.
  • Align supply strategy to eliminate over-stock and stock-outs. Define thresholds & reorder quantities.
  • Automated alerts for subject status tracking and replenishment requirements.
  • Live dashboards & status reports for increased visibility.
  • Quick deployment and Integration.
  • Manage Patient Diaries
  • Manage Out-bound calls and reminders
  • System Security and Back-up