The scope and purpose of the StudyBuilder is to support the clinical study process from planning, study design, study specification, study set-up to drive downstream automation

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End-to-end process support

Support use of new concept based data standards from protocol set-up, study specification, clinical systems setup and preparation of submission data deliverable. Study Builder that support study specification tasks for Trial Management, Clinical Reporting, Data Management and Biostatistics.


Manage master data and definitions for CDISC Data Standards and other industry standards. Support clinical system set-up and end-to-end data integrations and higher degree of automation from study outline to submission.


Modern graph database with linking between related elements within and across standards (code lists) and studies. Transparent API-based architecture ensuring simple system integrations and future expanded use via dedicated APPs. Simple and intuitive user interface based on modern application framework.