Systems and methods for managing clinical research

Abstract

The disclosure relates to a computer system for managing medical research data. The computer system may include a network interface connecting the computer system a plurality of data providers. The computer system may include a plurality of data adaptors, each data adaptor configured to communicate with one or more of the data providers to obtain data in a respective data format. The computer system may include a data processor configured to control processing resources based on a volume of data obtained from the plurality of data providers. The computer system may include a plurality of data converters executed by the processing resources, each data converter configured to convert the obtained data from a corresponding data adaptor in the respective data format to a common data format including first metadata based on the obtained data. The computer system may include a data repository for storing data in the common data format.

1 . A system for managing medical research data, the system comprising:
 a plurality of data converters that are each configured to convert clinical and real-world data including both structured and unstructured data in a plurality of different data formats and the relate to respective medical research participants to a common data format that is labeled with first metadata associating the clinical and real-world data to each respective medical research participant;   a data repository configured to store medical research records of the clinical and real-world data as unstructured raw data, with each medical research record including transaction metadata that provides details of a transaction timing, content type and source of the clinical and real-world data for each medical research record relating to the respective medical research participants, such that each medical record is configured to be independently accessible even after a change in the respective data format;   at least one data pipeline configured to query the data repository to parse the unstructured raw data using the transaction metadata to obtain at least one document and to publish the unstructured raw data resulting from the at least one document into at least one field of a structured database, wherein the at least one data pipeline tags the at least one field in the structured database with display control metadata; and   a management portal configured to determine whether to display contents of the at least one field based on the display control metadata.   
     
     
         2 . The system according to  claim 1 , further comprising:
 a network interface coupled to a plurality of data providers that provide a plurality of data schemas and transmission mechanisms for providing the clinical and real-world data; and   a plurality of data adaptors that are each configured to communicate with one or more of the data providers to obtain the clinical and real-world data and that provide the clinical and real-world data to the plurality of data converters, respectively.   
     
     
         3 . The system according to  claim 1 , wherein the management portal is further configured to:
 assign a role to each user of the computer system;   receive a request to display a report including the at least one field; and   generate the report that displays, hides, or masks the contents of the at least one field based on the display control metadata and the assigned role of the respective user.   
     
     
         4 . The system according to  claim 2 , wherein the plurality of data adaptors are modules configured for processing the clinical and real-world data in a respective data format obtained via a respective interchange mechanism. 
     
     
         5 . The system of  claim 2 , further comprising a data processor configured to provide scheduling configuration services to the plurality of data adapters, wherein the scheduling configuration indicates a schedule for the corresponding data provider to provide the clinical and real-world data. 
     
     
         6 . The system of  claim 5 , wherein the plurality of data converters are distributed cloud services, and wherein the data processor is further configured to provide a dashboard interface including a chart of total processing rate by time, a chart of utilization of the distributed cloud services, and a measure of utilization cost. 
     
     
         7 . The system of  claim 1 , wherein the common data format is a JavaScript Object Notation (JSON) object including a key and an unstructured data portion. 
     
     
         8 . The system of  claim 1 , wherein the display control metadata indicates an access level based on the first metadata indicating a content type of the unstructured raw data. 
     
     
         9 . The system of  claim 1 , further comprising an analytics server configured to generate pre-defined data cubes based on the structured database. 
     
     
         10 . The system of  claim 3 ,
 wherein the role of each user includes at least roles of: participant, physician, and study manager, and   wherein the participant role is associated with a family model including a parent role that is allowed to generate documents on behalf of the associated participant role and generate documents for the parent role.   
     
     
         11 . A method for managing medical research data, the method comprising:
 converting clinical and real-world data including both structured and unstructured data in a plurality of different data formats and the relate to respective medical research participants to a common data format that is labeled with first metadata associating the clinical and real-world data to each respective medical research participant;   storing, in a data repository, medical research records of the clinical and real-world data as unstructured raw data, with each medical research record including transaction metadata that provides details of a transaction timing, content type and source of the clinical and real-world data for each medical research record relating to the respective medical research participants, such that each medical record is configured to be independently accessible even after a change in the respective data format;   querying the data repository to parse the unstructured raw data using the transaction metadata to obtain at least one document;   publishing the unstructured raw data resulting from the at least one document into at least one field of a structured database;   tagging the at least one field in the structured database with display control metadata; and   determining, by a management portal, whether to display contents of the at least one field based on the display control metadata.   
     
     
         12 . The method according to  claim 11 , further comprising:
 coupling a network interface to a plurality of data providers that provide a plurality of data schemas and transmission mechanisms for providing the clinical and real-world data; and   communicating, by a plurality of data adaptors, with one or more of the data providers to obtain the clinical and real-world data and that provide the clinical and real-world data.   
     
     
         13 . The method according to  claim 11 , further comprising:
 assigning, by the management portal, a role to each user of the computer system;   receiving, by the management portal, a request to display a report including the at least one field; and   generating, by the management portal, the report that displays, hides, or masks the contents of the at least one field based on the display control metadata and the assigned role of the respective user.   
     
     
         14 . The method according to  claim 12 , further comprising processing, by the plurality of data adaptors, the clinical and real-world data in a respective data format obtained via a respective interchange mechanism. 
     
     
         15 . The method of  claim 12 , further comprising providing, by a data processor, scheduling configuration services to the plurality of data adapters, wherein the scheduling configuration indicates a schedule for the corresponding data provider to provide the clinical and real-world data. 
     
     
         16 . The method of  claim 15 , further comprising providing, by the data processor, a dashboard interface including a chart of total processing rate by time, a chart of utilization of distributed cloud services, and a measure of utilization cost. 
     
     
         17 . The method of  claim 11 , wherein the common data format is a JavaScript Object Notation (JSON) object including a key and an unstructured data portion. 
     
     
         18 . The method of  claim 11 , further comprising indicating, by the display control metadata, an access level based on the first metadata indicating a content type of the unstructured raw data. 
     
     
         19 . The method of  claim 11 , further comprising generating, by an analytics server, pre-defined data cubes based on the structured database. 
     
     
         20 . The method of  claim 13 ,
 wherein the role of each user includes at least roles of: participant, physician, and study manager, and   wherein the participant role is associated with a family model including a parent role that is allowed to generate documents on behalf of the associated participant role and generate documents for the parent role.