The OpenStudyBuilder is a new approach to improve the collaboration within the clinical trial by breaking down silos. It is an approved project by the CDISC Open-Source Alliance (COSA) and it is expected to bring a change in policy and make it easier to create protocols, Case Report Forms, and Study Data tables.

This tool is an open-source project for clinical evaluations that will drive end-to-end consistency and more efficient processes – all the way from protocol development and CRF design – to creation of datasets, analysis, reporting, submission to health authorities and public disclosure of study information.

The OpenStudyBuilder, built by EvidentIQ, Novo Nordisk, Neo4j, and Microsoft, can be used by study designers, medical writers, data managers, people on standards management, biostatistics, clinical pharmacology and more. Aside from enabling seamless interoperability and cross-functional end-to-end study-team collaboration, it can also centrally store study design data for multiple down-stream usages, enable insights via enhanced search and explore, and have a sustainable model for maintenance and integrations. This solution will help save time and resources and minimize errors and discrepancies.

EvidentIQ’s contribution to the project, headed by Nicolas de Saint Jorre, is to support system design, system documentation, system validation, open-source project support and services. The OpenStudyBuilder is maintaining a complete consistency between the protocol, Case Reports Forms, SDTM tabulation and ADaM reports by sharing the metadata at both the Library and Studies level.

The OpenSourceBuilder is based on industry standards from CDISC with the goal to drive this as an open-source collaboration. The first minimal viable product release is planned  for Q3 2022.