Past Events¶

DMB Annual Conference¶

(21 November 2023, live event in Paris, France)

The OpenStudyBuilder as a new Metadata Repository solution

by Nicolas de Saint Jorre, Novo Nordisk and Katja Glass, Consultant

DMB - Association Francaise de Data Management Biomedical

The OpenStudyBuilder is an open source project for clinical study evaluations. This tool is a new approach for working with studies that once fully implemented 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. Learn how we are building a complete solution based on a clinical knowledge graph that includes a shared API, a custom web application, and exploration tools to further analyze the data. We will also share the open source vision behind the project and how you can help! The OpenStudyBuilder, originally created by Novo Nordisk, a global healthcare company, uses Neo4j as its database, along with other products from the Neo4j ecosystem, including NeoDash, Bloom, and the neomodel Python library. Neo4j's professional services team is also involved in the development and deployment of the solution.

The presentation slides are available here.

PHUSE EU Connect¶

(5-8 November 2023, live event in Birmingham, UK)

Open-Source Protocol Automation with the OpenStudyBuilder

by Mikkel Traun and Nicolas de Saint Jorre, Novo Nordisk

The OpenStudyBuilder is a powerful tool designed to streamline the end-to-end process of clinical trials. With its innovative protocol automation capabilities, the OpenStudyBuilder simplifies the management of protocol information, allowing for the easy creation and maintenance of protocol content. Through standard interfaces (APIs), a Word addon can be used to fill structural parts of the protocol, including complex parts like the schedule of activity flowchart.

In this presentation, we will demonstrate how the OpenStudyBuilder can be used to facilitate efficient protocol automation and how this is related to the ICH M11 guideline for clinical study protocols.

The presentation slides are available here. The paper is available here.

Open-Source MDR & SDR - Managing your standards with the OpenStudyBuilder

by Nicolas de Saint Jorre and Mikkel Traun, Novo Nordisk

The OpenStudyBuilder is a highly innovative open-source project that provides both a data standards metadata repository (MDR) and a study definitions repository (SDR). Developed as part of the CDISC 360 project and shared under the CDISC Open Source Alliance (COSA), the OpenStudyBuilder is designed to automate the entire end-to-end process from protocol to TLFs.

This presentation will demonstrate how the OpenStudyBuilder adopts industry standards such as CDISC Codelists and any dictionaries, while also effectively managing sponsor and CRF standards. Additionally, it supports standard interfaces like the TransCelerate DDF projects API, making it a highly versatile tool. The OpenStudyBuilder uses modern graph technology to facilitate seamless end-to-end processes and traceability, using biomedical concepts like those found in the COSMoS project from CDISC. With its robust capabilities and adaptability, the OpenStudyBuilder is a valuable tool for all those involved in clinical research.

The presentation slides are available here. The paper is available here.

CDISC US Interchange¶

(18-19 October 2023, live event in Falls Church, VA, USA)

**OpenStudyBuilder - an open-source DDF and COSMoS compatible solution **

by Mikkel Traun, Novo Nordisk

This presentation will explore the use of OpenStudyBuilder, a Digital Data Flow (DDF) and CDISC Conceptual and Operational Standards Metadata Services (COSMoS) compatible metadata repository (MDR) solution.

The OpenStudyBuilder is developed as an outcome from the CDISC 360 project and shared as open source under COSA aiming for end-to-end automations from protocol to TLFs. The solution consists of a Study Builder App connected to a Metadata Repository holding data standards and a Study Definition Repository with study specifications.

OpenStudyBuilder is based on concept-based standards providing a generalized, implementation independent way of defining complex data elements that have multiple relationships and attributes. This presentation will demonstrate how concept-based standards can be used to define the objectives, endpoints, activities, and scheduling of these in the study design - and how this can be applied as structured protocol content and digitalized study specifications.

The presentation slides are available here.

Workshop (at CDISC US Interchange)¶

(17 October 2023, Falls Church, VA, USA)

We performed a workshop on Biomedical Concepts.

The matierial is available here.

Community Meeting (virtual)¶

(16 October 2023, virtual event)

In this community meeting we discusses about some needs and questions some members had. It was a more technical documentation, where we checked out how it is possible to see the data structure and it was recommended that the structure could also been displayed by using graph tools which is better exchangable than the current visualization.

Additionally we had been talking about the licenses. The only requirement to non-open-source-software in this project is the database - Neo4j. If you want to use the OpenStudyBuilder solution in production, a Neo4j enterprise edition is recommended. Additional questions and the need for documentation is available. We take this task up and will write down a guide or information on our projecthomepage hopefully this year.

A third discussed aspect was authentification. As this is important when you want to use this in other environments and probably also with other systems then Azure, additional documentation is needed. We will document experiences of a community member inclusion a possible solution. As this process is not finished yet, this might take time.

It will also be interesting to see how the different graph models can work together as the OpenStudyBuilder has a strong metadata graph model which might be connected with other local graph systems. This is an open question on how to.

PHUSE SDE - Copenhagen, Denmark¶

(10 October 2023, live event in Copenhagen)

We showed our OpenStudyBuilder poster, had a live demonstration and talked to many people at the event.

The poster is available here.

Community Meeting (virtual)¶

(25 September 2023, virtual event)

We had our community meeting and talkes about the general functionality.

SEND Webinar, Electronic Nonclinical Protocol Design¶

(11 July 2023, virtual webinar 5:00 PM - 6:00 PM CEST)

SEND Webinar | Electronic Nonclinical Protocol Design for Sharing Between Systems

by Bob Friedman, Xybion

In this live webinar, Bob Friedman, an active member of the CDISC SEND standards consortium for ten years and an active member in the PhUSE/FDA Industry Collaboration, will discuss and demonstrate the next generation of nonclinical protocol development using OpenStudyBuilder.

Join this free webinar to learn:

• In-depth insights on the latest industry trends in nonclinical protocol development.
• Expert guidance on best practices for improving your organization's nonclinical protocol development.
• A demonstration of how OpenStudyBuilder can streamline the nonclinical protocol development process.
• An opportunity to network with other industry professionals and share your ideas and questions during the Q&A session.

Don't miss out on this opportunity to stay ahead of the curve in nonclinical protocol development. We look forward to your participation in this exciting webinar.

The presentation slides are available here.

PHUSE SDE - Heidelberg, Germany¶

(22 June 2023, live event in Heidelberg)

OpenStudyBuilder - Experimentation Examples

by Katja Glass, Katja Glass Consulting

The OpenStudyBuilder is a versatile open-source solution that serves as both a clinical metadata repository (MDR) and study definition repository (SDR). Developed as part of the CDISC 360 project, it is fully compliant with COSMoS and Digital Data Flow (DDF) standards, making it a powerful tool for managing clinical trial data.

This presentation offers a deep dive into the features of OpenStudyBuilder, highlighting how it streamlines processes related to study setup, protocol automation, and CRF development, as well as managing standards. We will demonstrate how you can leverage OpenStudyBuilder to explore dashboards based on biomedical concepts, export information in DDF format, automate protocol creation, and much more. You can gain valuable insights and inspiration on how you can benefit and collaborate!

The presentation slides are available here.

GUF Meeting (French CDISC User Group)¶

(15 June 2023, live event in Indre-et-Loire, France)

There was the French CDISC User Group which meets live in France. Nicolas has presented a "Presentation de OpenStudyBuilder: Metadata Repository (MDR) open source".

The presentation slides are available here.

Community Meeting (virtual)¶

(8 June 2023, 15:00-16:00 CEST, virtual event)

We had our community meeting where everyone was invited to dicuss any topic. This time we had quite some questions about the activity concepts (guide on the activity concepts here). Furthermore we discusses how to best get started. You might want to look for the demonstration video showing what is currently implemented here. We also have a collection of useful resources here. The public sandbox environment is available, where you can easily play around with the tool and test data as described here.

Join us at the OpenStudyBuilder community meeting! Don't miss out on the opportunity to attend the OpenStudyBuilder community meeting, where we'll demonstrate functionality, provide insightful answers to your questions, and encourage lively discussions on a wide range of subjects.

OpenStudyBuilder Community Meeting (virtual)¶

(05 May 2023 - 15:00-16:00 CEST, virtual event)

Everyone was invited to join our OpenStudyBuilder community meeting. After a short introduction we answered questions and showed areas people had been interested in. There was a huge interest in the CRF part including CRF related edit checks which could be added in the "Sponsor Extensions". Apart from the fact, that the ODM.XML can be exported, it is also possible to import ODM.XML - ideally you need to check that the codelists match the CDISC CTs, otherwise new sponsor specific codelists might be created. A nice note is that we are looking into the ICH M11 guideline about structured protocols. CDISC is looking into this guideline as well, so hopefully we can collaborate on this as well.

CDISC Europe Interchange (Copenhagen, Denmark)¶

(26-27 April 2023, live event in Copenhagen)

We presented a poster on the OpenStudyBuilder and had nice demonstration sessions at the COSA booth. Furthermore there was a presentation by Marius Conjeaud (Neo4j) and Nicolas de Saint Jorre (Novo Nordisk):

All you wanted to know about Blood Pressure but were afraid to ask

The presentation slides are available here.

COSA Biomedical Concept & OpenStudyBuilder Workshop (Copenhagen, Denmark)¶

(25 April 2023, Copenhagen, 9:00-15:00)

At this workshop we will dive into what Biomedical Concepts (BC) is, and how the can be applied within a MDR data standards repository and a SDR study definitions repository - illustrated within the OpenStudyBuilder (OSB) solution.

We will as well relate to how BC's are defined within COSMoS, DDF, d4k and other models. There will be a shared introduction followed by 4 breakout sessions, leading to a shared reflection and discussion on how we can support and bring these initiatives forward. The 4 breakout sessions are currently defined as:

• Breakout 1: Setup BC's in OSB SoA for a new study, run various queries to learn how BC's can be utilised
• Breakout 2: Learn and understand the BC model in OSB versus the COSMoS, DDF, d4k and other models
• Breakout 3: Create and curate OSB BC content and mining BC's from existing data sources like SDTM

Summary: We could get a good overview about the different initiatives related to Biomedical Concepts, what the differences are and possible ways forward. Specifically the high participation from CDISC and other experts in the BC field enabled excellent introductions, discussions and a fantastic collaborative opportunity. Thanks for all who joined the workshop.

Slides are available - an article is likely to come soon:

• Introcution Session
• Breakout 1 - Biomedical Concepts in OpenStudyBuilder
• Breakout 2 - Understand BCs in OpenStudyBuilder, COSMoS, DDF, d4k
• Breakout 3 - Curate BCs

OpenStudyBuilder for Pre-Clinical at Society of Toxicology (Nashville, USA)¶

(21 March 2023, Nashville, 9:00-10:00)

We are going to present how the OpenStudyBuilder can be utilized in the pre-clinical space using SEND, how protocol automation could be performed as well as how collaboration in this space can embrace further standardization and standard tools.

The slides are available here.

Presenter: Bob Friedmann, Xybion & Katja Glass, Katja Glass Consulting

PHUSE EU Connect (Belfast)¶

(13-16 November 2022, live event in Belfast)

Vision and demonstration of the OpenStudyBuilder for supporting structured protocol content and submission deliverables using concept-based standards

by Martin Gram and Mikkel Traun, Novo Nordisk A/S

OpenStudyBuilder is developed as an outcome of the CDISC 360 project and as a Digital Data Flow (DDF) compliant solution. The vision is to make metadata driven study specifications based on concept-based standards to be applied in protocol development, downstream system setup and SDTM submission deliverables. It includes an MDR component for managing versioned external and sponsor-defined data standards.

This poster will demonstrate the solution by:

• Showing how concept-based standards can be applied to define a study e.g., specifying objectives, endpoints, activities with reference to the study design schedule.
• Defining SDTM trial summary parameters, study arms, elements, epochs, and visit schedules.Creating structured protocol content directly from the repository.

OpenStudyBuilder is currently being developed by Novo Nordisk in collaboration with vendors. Our ambition is to share the solution as open source under COSA and thereby contribute to improvement of tools supporting digitalisation in clinical development.

Talk to us

Many used the opportunity to talk to us and see a brief demo.

The poster is available here.

OpenStudyBuilder Q&A (virtual)¶

(07 November 2022 - 15:00-16:00 CET, virtual event)

Join the open Q&A session to ask and discuss anything about the OpenStudyBuilder

We had great talks similar to the first Q&A session. We had quick demonstration of various aspects of the OpenStudyBuilder and many discussions.

CDISC US Interchange (Austin, Texas)¶

(26-27 October 2022, live event in Austin, TX)

Concept-based standards in OpenStudyBuilder supporting structured protocol content and submission deliverables

(27th October 2022 - Session 5: Track B - Trial Design - 8:30 - 9:00CT)

by Mikkel Traun, Novo Nordisk A/S

OpenStudyBuilder is developed as an outcome of the CDISC 360 project and as a Digital Data Flow (DDF) compliant solution. The vision is to make metadata driven study specifications based on concept-based standards to be applied in protocol development, downstream system setup and SDTM submission deliverables.

The solution includes an MDR component for managing versioned external and sponsor-defined data standards as concept based end-to-end standards linked from protocol specification, data collection to submission datasets. This presentation will focus on how we define and apply the concept based data standards.

OpenStudyBuilder is currently being developed by Novo Nordisk in collaboration with vendors. Our ambition is to share the solution as open source under COSA and thereby contribute to improvement of tools supporting digitalisation in clinical development.

Slides including demonstration pictures are available here.

CDISC Open Source Alliance Booth / COSA Booth

There had be a high interest in demonstration and talks at the COSA booth around the OpenStudyBuilder. The next interchange will also have a booth and a time schedule, so use further chances for live demonstrations and direct talks!

OpenStudyBuilder Q&A (virtual)¶

(24 October 2022 - 15:00-16:00 CEST, virtual event)

Join the open Q&A session to ask and discuss anything about the OpenStudyBuilder

We provided a quick overview of the OpenStudyBuilder (10') and the most important links - see slides. The tool went live today on 24. October 2022 with the first version of the minimum viable product (MVP) in version 0.1. Then we started discussions around this tool.

We have been discussing how the OpenStudyBuilder could be used to support also the pre-clinical phases. The SEND terminology is available in the OpenStudyBuilder. The trial summary datasets are very similar, but there is one additional dataset which could then be added at some point in time. The OpenStudyBuilder contains a lot, but many more things can and should be added. The OpenStudyBuilder is looking also for the pre-clinical area very valuable.

The terminologies have been shown during the meeting. A nice feature for terminologies is to view differences from one version to another. To load terminology updates to the system, currently an administrator running python commands is required. This is one functionality which should be enhanced in the future.

There are many things on the road map. Novo Nordisk is currently working on this as this is a missing part. When a decision on the roadmap has been performed by Novo Nordisk, this will be shared with the community as well. Collaborations enable additional priorities, so even though the core road map might priorize some items lower, a functionality might come earlier through collaboration.

The biomedical concept which is used can be browsed through the neo4j browser which is part of the sandbox environment and the local installation is very important and enables FAIR data. This is very powerful as concepts and contents are linked. This allows also later on to link and search specific information. Currently it is not planned to store the data as linked data. But that is likely on the roadmap far away.

We checked some examples for assessments and how there are stored in the OpenStudyBuilder. Also, the Protocol tool which is currently not open-source has been showed. This tool is running as a Word add-in using the APIs to get the required data. The API layer is very powerful as this enables data consumption and provision for any content.

A question about maintenance came up. As this is an open-source project it relies on the community to support general topics and issues. When there is a more detailed need for support, then it is recommended to use vendors commercially. The current contributors are lists and can easily be contacted. The OpenStudyBuilder would also be happy to include additional vendors to provide services around the OpenStudyBuilder. Novo Nordisk has no intention of being a software provider. The idea is to facilitate knowledge sharing and sharing these solutions among pharma companies. Then there could be a network of suppliers that can give you professional services around the use and installation and integrations and validations and so on.

A lot of documentation is available. The community documentation is this page here. Then we do have the repository documentation along with the source code in GitLab.. And finally, there is the in-build tool documentation which can be access by the local installation the "documentation" area or through the sandbox access where the documentation is available as well.

PHUSE EMEA Autumn SDE (Copenhagen)¶

(13 October 2022, live event in Copenhagen)

by Mikkel Traun, Novo Nordisk A/S, Katja Glass, Consultant and others

Presentation: OpenStudyBuilder - Open Source MDR

The OpenStudyBuilder is based on a proof of concept as part of the CDISC 360° project and is aiming to be a Transcelerate Digital Data Flow compliant implementation aiming for an end-to-end process. Metadata driven concept-based standards can ease our processes and tools. This presentation will show how we can benefit from working with connected metadata with the focus for SDTM and ADAM.

The OpenStudyBuilder is built by Novo Nordisk in collaboration with other vendors. It is (going to be) available as open source. This can become a game changer in our industry, as this will allow for full-scale collaborations that not only discuss processes and tools, but also share implementations, creating flexible and generic toolsets! By using standard APIs, e.g. those from the Transcelerate DDF project, a flexible, generic and interoperable tool landscape can be built. Just like what we are used to from plug and play apps!

The MDR as the heart, contains all the metadata and core study data information. The API allows many possible up and down stream integrations enabling system and data integrations. This includes the opportunity to create SAS macros or R functions to download information to the evaluation environments or even upload information.

Slides are available here. The poster is available here.

DDF Connectathon¶

(12-30 September 2022, virtual 3-week-event)

DDF Showcase

We join the DDF Connectathon with an OpenStudyBuilder show case.

Our OpenStudyBuilder team demonstrated how the OpenStudyBuilder, as a DDF reference implementation, can handle next to DDF USDM also additional data and standards in order to enable end-to-end consistency, automation and support efficient processes from protocol development and CRF design to the creation of data sets.

The OpenStudyBuilder team covered:

OpenStudyBuilder Development

• Managing standards: CDISC CT, Dictionary Terms, Concepts & Internal (sponsor standards)

DDF API Adapter

• Utilising Transcelerate SDR/USDM to integrate
• Other downstream systems can utilize OpenStudyBuilder API

EDC Integration

• Via DDF API adapter
• Via OpenStudyBuilder native API
• Via ODM-XML file with extensions

Demo videos are available under DDF Context. The following slides has been used: DDF compliant SDR, ODM and Protocol.

GraphSummit Copenhagen¶

(08 September 2022, live event in Coppenhagen)

by Henrik Enquist, Advanced IT Developer, Novo Nordisk

Leveraging the Graph for Clinical Standards/Trials: Novo Nordisk

Learn how Novo Nordisk achieved success with Neo4j and their future plans for more graph applications.

Slides are available here.

PHUSE EMEA SDE - Basel¶

(21 June 2022, live event in Basel)

by Katja Glass, Consultant (Community Manager for OpenStudyBuilder)

OpenStudyBuilder - The Game Changer

The OpenStudyBuilder is an open-source project run by NovoNordisk with the intention to support the future CDISC and DDF standards. It can become a game changer to enable the next step of collaboration together with common processes and workflows. Only when we share and discuss also tool implementations including supporting processes, we can build a common toolset and processes which we can use throughout our complete industry. This presentation will show a brief description of the OpenStudyBuilder tool and will show how we as industry can make use of it and design additional processes and tools as building blocks supported by a generic design, specific APIs and the will to change.

Slides are available here.

GraphConnect 2022¶

(6-8 June 2022, live event in Austin, TX, USA)

by Marius CONJEAUD (NEO4J) and Nicolas DE SAINT JORRE (QUANTICSOFT / EVIDENTIQ)

Creating a Clinical Knowledge Graph: Pharmaceutical Collaboration With OpenStudyBuilder

OpenStudyBuilder is an open source project for clinical study evaluations. This tool is a new approach for working with studies that once fully implemented 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. Learn how we are building a complete solution based on a clinical knowledge graph that includes a shared API, a custom web application, and exploration tools to further analyze the data. We will also share the open source vision behind the project and how you can help! The OpenStudyBuilder, originally created by NovoNordisk, a global healthcare company, uses Neo4j as its database, along with other products from the Neo4j ecosystem, including NeoDash, Bloom, and the neomodel Python library. Neo4j's professional services team is also involved in the development and deployment of the solution.

Slides are available here.

Graph Meetup Amsterdam¶

(12 May 2022, 18:00-20:00, live event in Amsterdam)

by Marius CONJEAUD (NEO4J) and Nicolas DE SAINT JORRE (QUANTICSOFT/ EVIDENTIQ)

OpenStudyBuilder - "All you wanted to know about Sex Blood Pressure but were afraid to ask?"

In this presentation we will demo this new OpenStudyBuilder application (in beta mode) starting from a very simple example: "To demonstrate the superiority of Drug A relative to Drug B on Blood Pressure (BP)". This will lead us into the magic world of Nodes and Relationships to illustrate how this clinical objective can be "translated" into a linked graph, reducing the number of inconsistencies!

This presentation should illustrate how a concrete NEO4J professional application will help Clinical Research to bring a new drug to the market faster. You will see how this Graph database will allow us to produce related and consistent data to improve life on Earth!

Slides are available here.

CDISC Open Source Alliance (COSA) OpenStudyBuilder Workshop¶

(29 April 2022, 9:00 - 13:00 CET)

by many colleagues

additional resulting material coming soon

At this workshop the following has been presented (slides):

• Why you should consider to use the OpenStudyBuilder solution
• Why we share OpenStudyBuilder as an open source project
• Why you should consider to contribute to the OpenStudyBuilder solution

Then we split into number of breakout sessions where a facilitator presented a focus area and demonstrate relevant functionalities in the OpenStudyBuilder tool and lead discussions. The group members could try these and then discuss and reflect. The goal for each breakout group had been to present a short overview of their reflections and recommendations within their focus area for everyone, where the outcome will be included soon

The following breakout groups had been defined:

• Use OpenStudyBuilder to make study specification for structured protocol content (slides)
• Use OpenStudyBuilder to make study specification for CRF and data collection (slides)
• Use OpenStudyBuilder to make study specification for SDTM Study Design datasets
• Use OpenStudyBuilder to manage concept-based standards, ideate on BC definitions & Use NeoDash reports for status reporting on study specifications, Ideate on format and meta-checks (slides)
• How to start evaluate and use OpenStudyBuilder, deployment options, system operations and integrations & Demonstrate DDF API adaptor and discuss DDF API alignment (slides)
• Ideate on business opportunities for vendor services for OpenStudyBuilder (slides)

CDISC EU Interchange¶

OpenStudyBuilder - Next Generation MDR Solution for Study Design and Configuration Using Concept-Based Standards

(27 April 2022, 16:00 - 16:30 CET)

by Mikkel Traun, Novo Nordisk A/S

Slides are available here.

CDISC Open Source Alliance (COSA) Spotlight¶

Introduction to OpenStudyBuilder

(31 March 2022, 16:00 - 17:30 CET)

Recording (starting at 45')

by Henrik Lynge, Vice President & Mikkel Traun, Principal Programmer, Novo Nordisk A/S

OpenStudyBuilder is a new approach to working with studies that once fully implemented 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.

Presentation - Next Generation MDR Solution¶

Next Generation MDR Solution for Study Design and Configuration Using Concept-based Standards

(15-19 November 2021 - PHUSE EU Connect)

Recording (needs EU Connect 2021 registration), Slides

by Mikkel Traun, Principal Programmer, Novo Nordisk A/S

An MDR PoC solution was developed as part of the CDISC 360 project to illustrate how a study specification can be made using the concept-based standards. Concept-based standards are generalised data standard elements which correspond to how objectives, endpoints, activities and assessments are defined and scheduled in the study design. At Novo Nordisk, we are applying the learnings from the CDISC 360 PoC as inspiration to develop our next generation MDR and support the end-to-end process for clinical data standards.

This presentation will demonstrate how these goals can be achieved through a Study Builder App connected to a Study Metadata Repository and its linked graph database. This MDR solution is developed by Novo Nordisk in collaboration with a few vendors. Our ambition is to share this MDR solution as an open-source project and thereby contribute to improving data standards and tools supporting clinical development.