Abstract: In general, techniques are described by which to enable code generation for clinical research systems. A computing device comprising a memory and a processor may implement the techniques. The memory may store a code generator. The processor may execute the code generator. The code generator may determine data collected in support of a clinical research study, and obtain a first mapping between the collected data and an intermediate concept that uniformly classifies the collected data. The code generator may also obtain a second mapping between the intermediate concept and a standard model that conforms to a regulatory standard. The code generator may further generate, based on the first mapping and the second mapping, transformational data that defines a transformation between the data collected in support of the clinical research study and data that conforms to the standard model, and output the transformational data.

Abstract: Techniques are disclosed for digitizing a framework for clinical development. In one example, a computing device comprising a processor and a memory may be configured to perform the techniques. The processor may first define a data model comprising metadata that specifies a data standard representative of requirements for regulatory-compliant exchange of data between entities. The data model may include one or more client objects, where each client object specifying a sequence of a plurality of gates for a process of a clinical research study protocol. Moreover, each gate of the plurality of gates defines one or more conditions for completion of the gate. The processor may express the data model to define the clinical research study protocol. The memory may store the data model.

Abstract: Techniques are disclosed for digitizing a framework for clinical development. In one example, a computing device comprising a memory configured to store a study and a processor may be configured to perform the techniques. The processor may receive, from a user, an input specifying a plurality of trial elements for the study, and receive, from the user, an input arranging the plurality of trial elements into a tree data structure. The processor may also determine, based on the tree data structure of the plurality of trial elements, one or more trial arms for the study, each trial arm of the one or more trial arms comprising a single path between at least one trial element of the plurality of trial elements to at least one other trial element of the plurality of trial elements. The processor may further output, for display, the one or more trial arms for the study.

Abstract: Techniques are disclosed for digitizing a framework for clinical development. In one example, A computing device comprising a memory configured to store a regulatory database, and one or more processors may be configured to perform the techniques. The one or more processors may retrieve, from the regulatory database, a template based on a governance process, receive, via a user interface, input from a user, parameterize the template based on the governance process with the user input to create a parameterized template, and store the parameterized template in a database.