Projection® IWRS - Interactive Web Randomization System

Projection® IWRS is an interactive web randomization system combining high performance with security and simplicity:

  • whether your study includes a few patients or several hundred, Projection® IWRS will match your needs.
  • Projection® IWRS is so intuitive it doesn't require any specific training.
It will work with any Internet browser and doesn't need to install anything on your computer. A simple Internet connection is enough.

Managing randomization

Projection® IWRS can randomize by different methods:

  • It can use a pre-established list of treatments to draw up a chronological treatments list,
  • It can include algorithms that balance treatment arms,
  • It can manage several stratification levels,
  • It can allocate treatments by country, by group of centers, or by center, and thereby:
    • simplify study logistics,
    • simplify labeling,
    • reduce shipment costs,
    • ...

Managing treatment packs

Projection® IWRS provides far more than simple interactive web randomization. It also offers end-to-end treatment pack management functionalities:

  • from pack ordering, which is triggered manually or automatically, to check that:
    • the green light has been given,
    • training has been completed,
    • regulatory documents have been signed,
    • ...
  • pack shipment to centers,
  • pack reception,
  • allocation to a patient: prescription printout,
  • stock management,
  • re-supply,
  • ...
Hospital investigators and pharmacists can at all times check instantly the stock situation in their center, and clinical research staff can see the stock situation in all centers. Provisional future stocks for the different centers can also be consulted.

General process

Traceability, security

Applicative security

Projection® IWRS guarantees total security in terms of access. All users are identified and granted system rights to match their profile (function).

Audit Trail

All access is tracked and logged, as are all changes made.

Patient safety

Projection® IWRS can check study inclusion and exclusion criteria, and will only dispense treatment packs if the patient complies.
Projection® IWRS manages drug expiry dates. A drug will only be allocated if its expiry date is compatible with the time necessary for its use.
Projection® IWRS provides real-time information about overall drug stocks for center and sponsor staff, and information on drug supplies dispensed to patients and stocks remaining. It can be used to recall or block a batch such that it will no longer be dispensed.

Guaranteeing success

The heart of this system, and its practical implementation in each clinical trial, have been validated as required by the regulations and in accordance with GAMP5 methodology.

Multilingual

Although Projection® IWRS can be set up to operate in English or French, randomization-specific pages can be prepared in a range of languages so that all users in multi-country studies see these pages in their native language.

Integration

Projection® IWRS can be used alone or integrated as an optional module of Projection® EDC.

In this case the module is fully integrated and often the randomization both creates the patient and is a prerequisite for entering patient data.

Regulatory compliance

Projection® IWRS is fully compliant with 21CFR Part 11. Data transmissions are encrypted through an SSL connection and all actions are monitored and logged (full audit trail).
Projection® IWRS includes electronic signature.

All Projection® System modules have been fully validated.

Arone's services

Arone can provide services around the IWRS:


Technical requirements

Projection® EDC is supported by Windows and Mac OS and runs smoothly on the most popular web browsers: Microsoft Internet Explorer, Mozilla Firefox, Apple Safari, Opera, Google Chrome, etc.