FlexRandomizer®
Cytel's Flexible Randomization Solution

Assuring patient treatment balance for even the most complex clinical trials

Dynamic randomization techniques used in clinical trials can eliminate patient selection bias while guaranteeing treatment balance, especially as trial designs grow in complexity.

The biases and imbalances caused by static randomization schemes can cause loss of statistical power, resulting in the premature termination of promising research.  This is a problem, in particular, for small to moderately-sized studies with numerous prognostic factors.

Flexible randomization supports static, dynamic and response-adaptive techniques in a centralized and integrated manner applicable to all trials in clinical development program.

The FlexRandomizer® Flexible Randomization Suite

Cytel’s FlexRandomizer is a proven, scalable solution for reliable, real-time, and centralized randomization for all clinical trials.  Functioning within an existing clinical technology infrastructure, it handles randomization across the study lifecycle: planning, operations, monitoring, and analysis.

FlexRandomizer leverages Cytel’s renowned expertise in computational statistics, adaptive trial methodologies, and enterprise deployment know-how.  The solution is an integrated web services set accessible from your existing applications.

FlexRandomizer's open and extensible web services architecture plugs into your existing interactive voice response systems (IVRS), web user interfaces, inventory tracking systems, and patient information databases.

Architecture

At the heart of the solution is the FlexRandomizer Flexible Randomization Engine. It’s this engine that implements the sophisticated randomization methods necessary to achieve better treatment and institutional balance.  It also facilitates faster and more accurate study of the effect of prognostic factors on patient response by avoiding reliance solely on post hoc analysis.  Modular in design, the engine can incorporate newer randomization methods when required.

The FlexRandomizer Engine configures to your particular clinical process logic via a set of defined business rules. Examples include your ‘forced randomization’ policy, randomization logic when inventory is unavailable at a site, or emergency unblinding procedures.

Simulation Services

Additionally, Cytel’s trial design simulation services help trial investigators reduce the risk of imbalance by analyzing various 'what if' scenarios during planning.  Trial simulations can mimic patient characteristics, arrival rates, treatment allocations, and compare different randomization schemes

Key Features and Benefits

• Reliable, continuous, real-time, flexible randomization providing better 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