Abstract: An automated method is provided of generating a report of data collected from multiple sources during a clinical trial. The data includes a plurality of different data fields. A plurality of patients participate in the clinical trial. A first set of data obtained from case report forms associated with the patients is received at a processor. The case report forms are one source of data. A second set of data obtained from at least one source other than the case report forms is also received at the processor. At least some of the data in the first and second set of data include data associated with the same data fields. The processor identifies any mismatches in data associated with the same data fields in the first and second set of data. Mismatches associated with data fields obtained from the same case report forms are electronically grouped. A report is then generated of the data. The report shows the status of mismatches for each case report form or type of case report form.

Abstract: An automated method is provided for generating summary data regarding task items that must occur to achieve a database lock for a clinical trial study that is performed based on a previously defined clinical trial protocol. The clinical trial study is managed using a processor and a database in communication with the processor. The database includes clinical trial data and the status of the data for a plurality of patients participating in the clinical trial study. At least one clinical database lock criterion is defined for the study from at least a plurality of user-selected subsets of the clinical trial data. The processor receives the at least one clinical database lock criterion for the study, and the clinical trial data and the status of the data, as retrieved from the database, for the plurality of patients participating in the clinical trial study as defined by the clinical database lock criteria.

Abstract: A computer-implemented method is disclosed for visualizing data relationships between components of a project for identifying potential duplication of selected components. One of the components is data collection assignments.

Abstract: An electronic method and article of manufacture is provided for analyzing clinical trial budgets. A clinical trial budget is input into a processor. The budget includes activities and associated activity costs of a clinical trial. The activities of the inputted clinical trial budget are classified into a set of standardized service categories. The processor is used to electronically allocate the associated activity costs with the respective standardized service category so that budget costs of the clinical trial can be objectively analyzed. A report of the associated activity costs with the respective standardized service category is outputted for use in analyzing budgets for clinical trials.

Abstract: A decison flowchart of a triage protocol is provided for a medical condition of a patient. The flowchart includes a plurality of decision blocks. Each decision block relates to one or more patient symptoms and/or considerations. A plurality of exit points are provided in the flowchart. Each exit point is associated with a respective decision block. Each exit point is reached upon the presence or absence of a symptom or consideration in the respective decision block. Each exit point recommends an action to be taken by the patient. The exit points may be customized. More specifically, the recommended action at selected exit points may be individually selected from a plurality of selectable actions. Thus, the decision flowchart may provide different recommended courses of action for a patient having the same symptoms and/or considerations based upon individual selections. The recommended action becomes an exit message for the respective exit point.

Abstract: An automated method is provided of generating a report of data collected from multiple sources during a clinical trial. The data includes a plurality of different data fields. A plurality of patients participate in the clinical trial. A first set of data obtained from case report forms associated with the patients is received at a processor. The case report forms are one source of data. A second set of data obtained from at least one source other than the case report forms is also received at the processor. At least some of the data in the first and second set of data include data associated with the same data fields. The processor identifies any mismatches in data associated with the same data fields in the first and second set of data. Mismatches associated with data fields obtained from the same case report forms are electronically grouped. A report is then generated of the data. The report shows the status of mismatches for each case report form or type of case report form.

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: A clinical trial study is modeled for automatically generating business intelligence information regarding the clinical trial study. The clinical trial study has a total budget amount and a total amount of deliverables. A software application program is provided that has equations and business rules that together define a process, a timeline, and deliverables associated with the clinical trial study. The program is populated with items including entities that have been contracted to provide the deliverables to the clinical trial study, budget items and amounts related to the deliverables for the respective entities that have been contracted to provide the deliverables, and for at least some of the budget items, a time frame in which the budget item is expected to be incurred or paid. Business intelligence information is then automatically generated using the equations and business rules in the program, and the items entered into the program.

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.

Abstract: An electronic method and article of manufacture is provided for analyzing clinical trial budgets. A clinical trial budget is input into a processor. The budget includes activities and associated activity costs of a clinical trial. The activities of the inputted clinical trial budget are classified into a set of standardized service categories. The processor is used to electronically allocate the associated activity costs with the respective standardized service category so that budget costs of the clinical trial can be objectively analyzed. A report of the associated activity costs with the respective standardized service category is outputted for use in analyzing budgets for clinical trials.

Abstract: A computer-implemented method is provided of analyzing budgets for clinical trials. A clinical trial budget is entered into a processor. The budget includes activities and associated activity costs. The activities are classified into a set of standardized service categories. The processor then allocates the associated activity costs with the respective standardized service category. The budget further includes assumption specifications. The processor further calculates per unit costs of the assumption specifications. The activities and the associated activity costs are then equalized against reference assumption specifications using at least the per unit costs.

Abstract: An automated method is provided for generating summary data regarding task items that must occur to achieve a database lock for a clinical trial study that is performed based on a previously defined clinical trial protocol. The clinical trial study is managed using a processor and a database in communication with the processor. The database includes clinical trial data and the status of the data for a plurality of patients participating in the clinical trial study. At least one clinical database lock criterion is defined for the study from at least a plurality of user-selected subsets of the clinical trial data. The processor receives the at least one clinical database lock criterion for the study, and the clinical trial data and the status of the data, as retrieved from the database, for the plurality of patients participating in the clinical trial study as defined by the clinical database lock criteria.

Abstract: An electronic method is provided of analyzing budgets for clinical trials. A clinical trial budget is entered into a processor. The budget includes activities and associated activity costs. The activities are classified into a set of standardized service categories. The processor then electronically allocates the associated activity costs with the respective standardized service category so that budget costs can be objectively analyzed. The budget further includes assumption specifications. The processor further calculates per unit costs of the assumption specifications. The activities and the associated activity costs are then equalized against reference assumption specifications using at least the per unit costs via calculations performed in the processor.

Abstract: Management of a database lock for a clinical trial study is provided. A database is provided that includes clinical trial data and the status of the data for a plurality of patients. Lock criteria is defined for the study from a plurality of selectable subsets of the clinical trial data. A processor automatically generates a list of tasks that must occur to achieve the lock defined by the lock criteria using the clinical trial data and the status of the data.

Abstract: Management of a database lock for a clinical trial study is provided. A database is provided that includes clinical trial data and the status of the data for a plurality of patients. Lock criteria is defined for the study from a plurality of selectable subsets of the clinical trial data. A processor automatically generates a list of tasks that must occur to achieve the lock defined by the lock criteria using the clinical trial data and the status of the data.

Abstract: A clinical trial study is modeled for automatically generating business intelligence information regarding the clinical trial study. The clinical trial study has a total budget amount and a total amount of deliverables. A software application program is provided that has equations and business rules that together define a process, a timeline, and deliverables associated with the clinical trial study. The program is populated with items including entities that have been contracted to provide the deliverables to the clinical trial study, budget items and amounts related to the deliverables for the respective entities that have been contracted to provide the deliverables, and for at least some of the budget items, a time frame in which the budget item is expected to be incurred or paid. Business intelligence information is then automatically generated using the equations and business rules in the program, and the items entered into the program.

Abstract: A clinical trial study is modeled for automatically generating business intelligence information regarding the clinical trial study. The clinical trial study has a total budget amount and a total amount of deliverables. A software application program is provided that has equations and business rules that together define a process, a timeline, and deliverables associated with the clinical trial study. The program is populated with items including entities that have been contracted to provide the deliverables to the clinical trial study, budget items and amounts related to the deliverables for the respective entities that have been contracted to provide the deliverables, and for at least some of the budget items, a time frame in which the budget item is expected to be incurred or paid. Business intelligence information is then automatically generated using the equations and business rules in the program, and the items entered into the program.