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Pioneering Integration Of Clinical Supply Simulation

Armen Hareyan's picture

Tourtellotte Solutions and Cytel Inc. announced the integration of tcVisualize and FlexRandomizer, a combination that simulates both supply chain and flexible randomization for adaptive clinical trials.

This simulation package is an essential requirement for the successful design and implementation of innovative clinical trials, including adaptive trials.

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Cytel is the leading provider of statistical services and software for the design and conduct of clinical trials. Tourtellotte is a leader in off-the- shelf and custom supply chain software for the pharmaceutical, retail, and consumer goods industries. The two companies demonstrated their integrated applications at the 2007 ExL Pharma Clinical Supply Forecasting Summit in Philadelphia.

Flexible, adaptive clinical trials, widely considered a key to productivity gains in drug development, can result in large improvements in lead time, cost, and success rates. However, the greater flexibility of these designs naturally increases uncertainties in clinical operations, especially in drug supply. The integrated tcVisualize and FlexRandomizer solution helps manage this uncertainty by analyzing alternatives and assuring success at reasonable cost.

"In merging clinical supply chain simulation with flexible randomization, this joint application finally allows drug and device development companies to gain the savings, both in time and cost, offered by adaptive trials. Companies will be confident that a large range of scenarios has been simulated to minimize the chance of unforeseen glitches," said Ranganath Nayak, Chief Executive Officer of Cytel Inc. Ed Tourtellotte, CEO of Tourtellotte Solutions, agreed. "The simulation software delivers great value to our customers. Bringing supply-chain predictability to trials that adjust as they go is a thrilling advance. It benefits the pharmaceutical industry -- and trial patients -- significantly."

The unified solution will be available to customers immediately from both companies. Tourtellotte's tcVisualize is a desktop-based visual simulator and forecaster that allows a supply team to run and compare unlimited supply scenarios with varying parameters and with actuals, and includes Monte Carlo analysis and variable dosing capability. Originally developed for Wyeth Pharmaceuticals, Cytel's FlexRandomizer allows reliable, real-time, flexible randomization that minimizes treatment imbalance, and accommodates a wide variety of trial parameters and designs, including blinded, multistage, and crossover studies. Cytel and Tourtellotte plan to add response-adaptive simulation capabilities later this year.