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OpenStudyBuilder :
Leveraging the Graph for
Clinical Trials and Standards
Katja Glass, OpenStudyBuilder Community Manager
Marius Conjeaud, Principal Consultant @ Neo4j
OpenStudyBuilder?
What’s that?
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
…
Past Processes
OpenStudyBuilder Vision
OpenStudyBuilder Vision
OpenStudyBuilder Vision
OpenStudyBuilder
3 Elements of OpenStudyBuilder
● Clinical Metadata and Study Definition Repository
(central repository)
● OpenStudyBuilder application
(User Interface)
● API layer
(allowing interoperability with other applications)
OpenStudyBuilder
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
A graph ? Why ?
Study
Study Objective
Study Objective
Category
(safety,
efficacy…)
Parameters
(Compound,
disease)
Study Objective
Category
(safety,
efficacy…)
Parameters
(Compound,
disease)
Allowed
values
(standards,
sponsor
data,...)
…
Leveraging the Graph for Clinical Trials and Standards
Congrats ! It’s a graph ! 👶
Next, add a pinch
of versioning…
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
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
?
?
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 ! 👶👶👶
Where do I go from here ?
OpenStudyBuilder -Get Started
- Project homepage (OpenStudyBuilder.com)
- Info Resources
- Demonstration video
- Newsletter available in LinkedIn
- Slack & E-Mail
- Source available in GitLab
OpenStudyBuilder -Get Started
OpenStudyBuilder -Get Started
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
27
Thank you!
katja.glass@glacon.eu
marius.conjeaud@neo4j.com
Neo4j Inc. All rights reserved 2024
28

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