FlexRandomizer® Specifications Overview

The FlexRandomizer solution leverages Cytel’s renowned expertise in computational statistics, adaptive trial methodologies, and enterprise deployment know-how. This validated solution uses Web services to enable seamless integration with your existing applications.

The CytelRAND® Engine

At the heart of the FlexRandomizer solution is the CytelRAND Engine for centralized randomization. The engine implements the sophisticated randomization methods necessary to achieve better treatment and site balance. Modular in design, the engine can incorporate newer randomization methods as required.

The CytelRAND Engine can be configured for a particular clinical workflows via a set of defined business rules. Examples include ‘forced randomization’ policies, handling inventory constraints at clinical sites, or emergency unblinding procedures.

Key Features

• Reliable, continuous, real-time, flexible randomization providing better patient treatment balance and reduced bias

• Accommodates a wide variety of trial parameters, and designs including adaptive, blinded, double blinded, multistage and crossover studies

• Integrates within an existing eClinical environment - plugs into your IVRS applications, web-based forms, inventory tracking, and patient information databases
  
  
• Sophisticated algorithms handle large, complex stratifications for pure Random Permuted Block Designs, Simon and Pocock’s Minimization, and Efron’s Biased Coin methods
  
  
• Validated methods to handle ‘forced randomizations’, inventory stock-outs, incorrect assignment updating, treatment assignment and label generation
  
  
• Flexibility to modify protocol schemes at run time - add/drop centers, treatment arms, generate new ranges, and others
  
  
• Concurrency control and roll back procedures for handling simultaneous requests