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Status

OpenStudyBuilder is an open-source project publicly released in October 2022. Since then, it has evolved continuously through agile development cycles, with new versions regularly published on GitHub. In October 2023, Novo Nordisk launched the first business release of OpenStudyBuilder internally - from that point on, all Phase 2 and 3 studies used it to generate structured study protocol content. By October 2025, the solution is used for all interventional studies (Phase 1-4) at Novo Nordisk. For this all Schedule of Activities are created within OpenStudyBuilder. Data collection enablement is the next milestone on the horizon. Today, OpenStudyBuilder is growing beyond a single-company solution. Bayer and Boehringer Ingelheim have joined as collaboration partners, marking the beginning of true industry co-development.

Getting Started

Checkout available resources!