Abstract: Healthcare takes more than 10% of the GDP of most developed countries Recent healthcare statistics show that it’s one of the largest and fastest-growing industries in the world. Today, approximately 30% of the world’s data volume is being generated by the healthcare industry. By 2025, the compound annual growth rate of data for healthcare will reach 36%. Generation of patient profile includes history of patient health visits, tests carried out and such other details are extracted from Medidata Rave. The raw data extraction process is time consuming, several variables are ignored and tedious process. The proposed work “Development of Patient Profile in Clinical data management” helps to solve the issues when extracting the data. The proposed work considers Medidata Rave® clinical data for building patient profile. It consists of modules namely data extraction module, Query Formulation Module and Report Generation Module. In the Data extraction module, the data set retrieved from the Medidata Rave for verification of the specifications stored in the cloud with the specification given to verify for the consistency of the data and identification of the missed variables. In the query formulation module, queries are formulated to fulfil the requirements given in the specification. The report generation module focuses on generating reports for patient profile, missing page report, subject status report and customized EDC report with clinical trial details. The project is implemented using the SAP BO (Business Object) tool is a cloud–based clinical data management system used to capture, manage, and report clinical research data. The outcome of the proposed work helped in developing customized dashboards to provide better visualization. It helped in building clinical data management system pertaining to generation of patient profile, clinical trial details and subject status report. Time taken to process data extraction, query formulation and generating reports was reduced by 70%.

Keywords: Medidata, Patient Profile, Clinical Data Management, Business Object, Dashboards.

| DOI: 10.17148/IARJSET.2022.96152