Abstract: A system is provided for use in distributing information associated with an investigational product, such as a pharmaceutical drug. The information includes electronic documents associated with the investigational product, and a plurality of different electronic reports based on real-time patient clinical study data of the investigational product. The system includes a database that stores the electronic documents, a virtual data room that is in electronic communication with the database and which includes a memory that stores the electronic reports, an information presentation module, and an information control administration module. The information presentation module causes a display of the information to a user of the virtual data room via a display screen. The electronic reports are generated using the real-time patient clinical study data when requested to be displayed. The information control administration module specifies which electronic reports will be made available to the user.

Abstract: A system is provided for use in distributing information associated with an investigational product, such as a pharmaceutical drug. The information includes electronic documents associated with the investigational product, and a plurality of different electronic reports based on real-time patient clinical study data of the investigational product. The system includes a database that stores the electronic documents, a virtual data room that is in electronic communication with the database and which includes a memory that stores the electronic reports, an information presentation module, and an information control administration module. The information presentation module causes a display of the information to a user of the virtual data room via a display screen. The electronic reports are generated using the real-time patient clinical study data when requested to be displayed. The information control administration module specifies which electronic reports will be made available to the user.

Abstract: An automated method is provided of graphically displaying predicted patient enrollment in a clinical trial study. The study has a plurality of clinical sites for enrolling patients in the study. A database is provided that includes a patient enrollment rate for each clinical site and a date of initial patient enrollment for each clinical site. Clinical site launch data is entered into a user interface display screen, including a target number of patients to be enrolled in the study, and a target date for completing the enrollment of the target number of patients. A graphical display is then generated of a running total number of patients predicted to be enrolled in the study for a succession of time periods from the data that is provided and entered via the user interface display screen.

Abstract: An automated process generates a displayable report of the status of clinical research sites in a clinical trial to identify readiness of sites to accept patients. The clinical trial has a plurality of sites in multiple countries which accept patients. A plurality of electronically tracked site-based milestones and separate country-based milestones are provided for the clinical trial. Each site is associated with a country. The status of the site-based milestones and country-based milestones are electronically tracked in a database. The site-based milestones and the country-based milestones are tracked separately from each other. A displayable report of the status of the electronically tracked site-based milestones and country-based milestones is automatically generated in a processor. The report separately identifies the status of the site-based milestones and the country-based milestones.

Abstract: A virtual data room distributes information associated with an investigational product, such as an investigational compound. The information includes documents associated with the investigational product; and reports based on live clinical study data of the investigational product. The live clinical study data includes cleaned and not cleaned data records. For a designated subset of data records, the reports use data associated with only cleaned data records, and for the remaining data records, the reports use data regardless of whether the data is associated with cleaned or not cleaned data records.