The need to test new drugs, medical devices and health care interventions continues to grow. The randomized clinical trial remains the gold standard for evaluating these drugs, devices and interventions. A standardized, well-tested software product that supports the rapid deployment of reliable randomization systems will reduce study start-up time and costs. During a Phase I Small Business Innovative Research grant NERI developed prototype software named Verandi. Verandi supports simple randomization, permuted block randomization and minimization allocation methodologies. The prototype integrates Internet, interactive voice response, e-mail and automated faxing technologies. The Verandi prototype will form the basis for developing a fully tested commercial product. This product will integrate the above mentioned technologies into a single piece of software. This software will have an automated installation procedure, extensive documentation for both study administrators and end-users. The product will have undergone extensive testing both inside and outside NERI. The Verandi prototype as well as experience developing study specific treatment allocation systems make NERI well suited to create a commercial software product that serves as a key component of well run clinical trials.
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