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: 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.

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: 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.

Abstract: The present invention is a method for conducting clinical trials. The clinical trial consists of the inventive system (10); a computing device (12); application database (11a), the personnel database (11b), and the trial data database; computing devices (14a), (14b), and (14c) for use by trial participants and trial investigators; computing device (15); computer devices (16a), (16b), and (16c) for use by trial monitors; computing devices (18a), (18b), and (18c) for use by laboratories to connect via the network (20).