| MEDIDATA SOLUTIONS, INC. Patent applications |
| Patent application number | Title | Published |
| 20110307267 | DISTRIBUTED RANDOMIZATION AND SUPPLY MANAGEMENT IN CLINICAL TRIALS - 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 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 previously configured for the multi-arm clinical trial is retrieved from a database based on the received trial identifier. The subject identifier is assigned to an arm identifier of the multi-arm clinical trial based on the randomization design. The arm identifier indicates an arm of the multi-arm clinical trial to which the subject has been assigned. | 12-15-2011 |
| 20110161101 | SYSTEM AND METHOD FOR CONTINUOUS DATA ANALYSIS OF AN ONGOING CLINICAL TRIAL - 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. 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. | 06-30-2011 |
| 20110153358 | PROTOCOL COMPLEXITY ANALYZER - The present invention includes a system and methods for planning a medical study. The system for planning a medical study includes a display device and a data store comprising a plurality of medical procedures for at least one of designing and executing a medical study. The system further includes a service delivery device operatively coupled to the display device and the data store. The service delivery device includes a processor and a memory for storing instructions. In response to receiving a request to plan a medical study, the memory causes the processor to (1) select a set of procedures from the plurality of medical procedures; (2) assign a work effort unit for each procedure included in the set of procedures, with the work effort unit based on at least one of procedure type, procedure cost, procedure time, and procedure phase; (3) calculate a complexity level for the set of procedures based on the work effort units; and (4) evaluate whether the complexity level is appropriate for the medical procedure by comparing the calculated complexity level to a threshold level, where the threshold value represents a desirable complexity level for the study. | 06-23-2011 |
| 20090319299 | SYSTEM AND TECHNIQUES FOR REPORTING ADVERSE EFFECTS - Techniques for collecting and reporting adverse events associated with a patient are disclosed. The techniques include providing a user interface to identify drug and medical conditions associated with the patient using standardized drug and medical terminology. The techniques also include generating and displaying a cumulative narrative of user selections on the interface. The cumulative narrative can be directly transmitted to one or more companies and/or and regulatory agencies. | 12-24-2009 |