OpenStudyBuilder¶
OpenStudyBuilder is the open-source solution for the industry establishing a single, standardized source of truth for digital study design specifications unlocking data and AI-driven operational and scientific excellence across clinical development.
See It in Action¶
Why OpenStudyBuilder?¶
Clinical study processes today are characterized by:
- Silos and rework - parallel work across disconnected teams leads to discrepancies and delays
- Manual, error-prone handovers - between professional groups, IT systems, and tools
- No end-to-end consistency - terminology used in protocol, CRF, and datasets diverges, blocking automation
OpenStudyBuilder solves this by implementing study specifications as linked, standards-driven metadata - one source of truth that feeds every downstream system.
What It Enables¶
End-to-end process support
From protocol authoring and CRF design through clinical system setup to submission data - all driven by shared standards, templates, and study design metadata.
One source of truth
Central storage of study design data and standards for multiple downstream usages, with versioning and full audit trail.
Automation and efficiency
Reduces manual steps, minimises errors and discrepancies, and supports automated downstream processes - resulting in faster reporting and submissions.
Modern, open architecture
Graph database, transparent API-based design, and a modular implementation that supports partial adoption and easy integration with existing systems.
Community-driven innovation
Project released under the CDISC Open Source Alliance (COSA) built on CDISC 360i and Digital Data Flow (DDF) principles - open to contributions from the entire industry.
Who Uses It¶
OpenStudyBuilder supports cross-functional study teams across the full clinical development lifecycle:
Standards Governance • Study Designer • Standards Management • Trial Management • Medical Writing • Data Management • Biostatistics • Medical & Science • Clinical Pharmacology
Project Milestones¶
- Q3 2022 - First open-source release
- Q4 2023 - First business go-live at Novo Nordisk; all Phase 2/3 studies using OpenStudyBuilder for protocol authoring
- Oct 2025 - Schedule of Activities live for all interventional studies (Phase 1–4) at Novo Nordisk
- Dec 2025 - First external code contribution from a pharmaceutical company (Boehringer Ingelheim)
- May 2026 - Signed collaboration agreement between Novo Nordisk, Bayer, and Boehringer Ingelheim - three major pharma companies jointly committing to the development and maintenance of OpenStudyBuilder
- 2026 - Industry adoption year: EDC automation, broader community rollout
Get Started¶
Try the live sandbox or watch demonstration videos without installing anything.
Sandbox access • Videos
Step-by-step user guides covering library standards, study setup, CRF management and more.
User Guides • Technical Docs
Connect with other users and contributors, attend events, and follow the newsletter.
Events • Newsletter • Community
Contact & Project Info¶
| Project type | COSA project (CDISC Open Source Alliance) |
| Owner | Novo Nordisk A/S |
| Repository | github.com/NovoNordisk-OpenSource/openstudybuilder-solution |
| OpenStudyBuilder@gmail.com | |
| Community meetings | Events |
| Slack | Join OpenStudyBuilder |
| Newsletter | LinkedIn Newsletter |
| Licenses | MIT • GPLv3 • CC-BY-4.0 |
| CDISC Standards | CDISC CT • CDASH • SDTM • ADaM • ODM-XML • Define-XML |
About the Project - system architecture, components, contributors, and background
Environments - deployment options and setup
Collaboration - open-source strategy, contribution, and licensing