OpenStudyBuilder is an open-source tool designed for clinical trials, providing a centralized repository for clinical metadata and study definitions, along with a user interface and an API layer for interoperability. It is closely linked to CDISC standards and aims to facilitate data integration, analysis, and study design through graph technology. The platform is customizable and encourages collaboration, seeking contributors and sharing resources for further development.

1. OpenStudyBuilder :
Leveraging the Graph for
Clinical Trials and Standards
Katja Glass, OpenStudyBuilder Community Manager
Marius Conjeaud, Principal Consultant @ Neo4j

2. OpenStudyBuilder?
What’s that?

3. Clinical Trials Flow
Protocol
Activities
Design Data
Collection (CRF)
Collecting
Clinical Data
(EDC) Analysis
Planning
SDTM
Specification
(SDTM)
ADAM
Specification
(ADAM)
Tables,
Figures,
Listings
Clinical
Study
Report
Risk
Assessment
Monitoring
Trial Posting
Data
Integration
…

4. Past Processes

5. OpenStudyBuilder Vision

6. OpenStudyBuilder Vision

7. OpenStudyBuilder Vision

8. OpenStudyBuilder
3 Elements of OpenStudyBuilder
● Clinical Metadata and Study Definition Repository
(central repository)
● OpenStudyBuilder application
(User Interface)
● API layer
(allowing interoperability with other applications)

9. OpenStudyBuilder

10. OpenStudyBuilder
- Open Source tool developed and maintained by Novo Nordisk
- Highly linked to standards & initiatives
- CDISC Standards
- Member of CDISC Open Source Alliance (COSA)
- TransCelerate DDF implementation
- Looking for collaborators

11. A graph ? Why ?

12. Study

13. Study Objective

14. Study Objective
Category
(safety,
efficacy…)
Parameters
(Compound,
disease)

15. Study Objective
Category
(safety,
efficacy…)
Parameters
(Compound,
disease)
Allowed
values
(standards,
sponsor
data,...)

16. …

18. Congrats ! It’s a graph ! 👶

19. Next, add a pinch
of versioning…

20. Root
C112419
Value 1
simplexvirus
Value 2
Herpes
simplex virus
This never changes
These change
over time
2
0
1
4
2
0
2
3 Value 3
Simplex virus
2016
Objects actually cover multiple nodes-
CDISC Term

21. Root
C112419
Game : pick the right version
2
0
2
3 Value 3
Simplex virus
L
A
T
E
S
T
Value 2
Herpes
simplex virus
2016
2022
2
0
1
4
Value 1
simplexvirus
2
0
1
5
Study
Objective
?
?

22. Root
C112419
Game : pick the right version
2
0
2
3 Value 3
Simplex virus
L
A
T
E
S
T
Value 2
Herpes
simplex virus
2016
2022
2
0
1
4
Value 1
simplexvirus
2
0
1
5
Study
Objective
?
?
Congrats ! It’s graphS ! 👶👶👶

23. Where do I go from here ?

24. OpenStudyBuilder -Get Started
- Project homepage (OpenStudyBuilder.com)
- Info Resources
- Demonstration video
- Newsletter available in LinkedIn
- Slack & E-Mail
- Source available in GitLab

25. OpenStudyBuilder -Get Started

26. OpenStudyBuilder -Get Started

27. OpenStudyBuilder is customizable…
and Neo4j can help you
Library data:
• Controlled Terminology - Sponsor extensions to CDISC standards;
• Other library data imported from CSVs : Activities, Units, …
Custom mappers:
• Library data - Plug-in your own source of CT or Data Models;
• Map study format - e.g. OSB can output Studies in USDM compliant format;
Extensions:
• The project is open source, so extending functionality is possible.
Neo4j Inc. All rights reserved 2024
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28. Thank you!
katja.glass@glacon.eu
marius.conjeaud@neo4j.com
Neo4j Inc. All rights reserved 2024
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