Abstract: A distributed clinical trial system that provides configurability, reusability and integration of randomization and inventory configurations for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of dispensing medication in a multi-arm clinical trial. In accordance with the method a subject identifier and a trial identifier are received from an electronic data capture system. The trial identifier indicates the multi-arm clinical trial, and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. An arm identifier is retrieved from a database based on the received subject identifier. The arm identifier indicates an arm in the multi-arm clinical trial to which the subject is assigned. Thereafter, treatment is determined for the arm identifier based on a treatment design previously configured for the multi-arm clinical trial.

Abstract: A distributed clinical trial system that provides configurability, reusability and integration of randomization for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of randomizing subjects in a multi-arm clinical trial. In accordance with a method, a subject identifier and a trial identifier are received from an EDC system. The trial identifier indicates the multi-arm clinical trial and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. A randomization design algorithm for the multi-arm clinical trial is retrieved from a database using the received trial identifier. The randomization design algorithm is executed.

Abstract: A distributed clinical trial system that provides configurability, reusability and integration of randomization and inventory configurations for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of dispensing medication in a multi-arm clinical trial. In accordance with the method a subject identifier and a trial identifier are received from an electronic data capture system. The trial identifier indicates the multi-arm clinical trial, and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. An arm identifier is retrieved from a database based on the received subject identifier. The arm identifier indicates an arm in the multi-arm clinical trial to which the subject is assigned. Thereafter, treatment is determined for the arm identifier based on a treatment design previously configured for the multi-arm clinical trial.

Abstract: A distributed clinical trial system that provides configurability, reusability and integration of randomization for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of randomizing subjects in a multi-arm clinical trial. In accordance with a method, a subject identifier and a trial identifier are received from an EDC system. The trial identifier indicates the multi-arm clinical trial and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. A randomization design algorithm for the multi-arm clinical trial is retrieved from a database using the received trial identifier. The randomization design algorithm is executed.

Abstract: System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data without suspending the ongoing clinical trial. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and a blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups.

Abstract: System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and a blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups. The ability to continuously monitor and analyze the trial data for statistical significance in tandem with data collection while the trial is ongoing provides many benefits to the researchers because the trial database no longer becomes the bottleneck in obtaining useful results and statistical analysis can be conducted on a near real-time basis without having to wait until completion of the trial.