Research infrastructures are building software tools and provide data services. Often these software solutions are to some degree redundant, for example, nearly each research infrastructure has developed its own data management system or data repository. Consequently, developers run into the problem of the sustainability of developed solutions. The academic research community needs better ways to collaborate and reuse and exchange developed software solutions. It is more important to foster the joint use of software tools or the exchange of existing solutions between projects than to develop new tools. Here we present a concept of mutual exchange of services and a form of deep collaboration. We suggest a concept for the integration and use of software tools by the joint usage of tools and services between different research infrastructures. Including: increased interoperability of clinical data management, biobanking, genetic databases, Electronic Health Records (EHR), query systems, data warehouses and imaging systems. This reciprocal usage creates mutual benefits. Services and tools developed by research infrastructures can be shared and jointly used for mutual benefit.

1. W. Kuchinke (2014)
Service
Integration in
Research
Infrastructures
Wolfgang Kuchinke
Heinrich-Heine University Duesseldorf
ECRIN Annual Meeting
19 May, 2014, Luxembourg

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The challenge
● Research infrastructures are building software tools and data services
● Often these software solutions are to some degree redundant, for example, nearly each research
infrastructure has developed its own data management system or data repository
● The developers run into the problem of the sustainability of the developed solutions
● The provision of the software solution as Open Source can lead to other problems

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Need for sustainability
● Often academic software and infrastructure development projects lack sustainability of their
products
● The EU commission expects that EU projects create an exit plan and sustainability strategy
– Projects need a sustainability strategy for the time after the project ends
● This is often addressed by a high quality of the product, a suitable license and by building a
community of potential users
● But most projects still lack a viable sustainability strategy that is strengthened by a business
plan and that considers economic conditions for software maintenance and service provision
● Many projects lack a large potential user community

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Objective
● Analysis of the service structure and the ways of software provision by different EU research
infrastructures
● Integration and use of new tools into the international clinical research infrastructure of ECRIN
● Joint usage of tools and services between different research infrastructures
– Increase interoperability of clinical data management, biobanking, genetic databases,
Electronic Health Records (EHR), query systems, data warehouses and imaging systems
● Find a sustainable solution for service provision that does not require high costs and user fees
● Find a solution that is flexible and scalable

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Ensuring sustainability of software tools
and services
● The EU projects p-medicine, TRANSFoRm, BioMedBridges and EHR4CR projects have developed
many services and tools for data management in research
– Especially in the area of data management and data warehousing, many similar solutions have
been developed
● The academic research community needs better ways to collaborate and reuse and exchange
developed software solutions
● Collaboration between EU projects should proceed stepwise from communication to more intensive
cooperation, coordination and finally to coadunation
– Three collaboration activities were defined
– networking, services / tools provision, partnership
● It is more important to foster the joint use of software tools or the exchange of existing
solutions between projects than to develop new tools
● For this purpose tools should be built in a modular fashion and employ common data standards and
ontologies

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EU Project Type of data Role of ECRIN
TRANSFoRm • GP care data / EHR
• patient data registries,
death registries, cancer
registries
• Legal & ethical framework
• Information model
• Using TRANSFoRm tools for clinical trials with primary care
data
• GCP compliance
• Knowledge transfer and training
EHR4CR HIS data / EHR • Requirements engineering
• GCP compliance
• International clinical trials expertise
• Use of EHR4CR tools for feasibility analysis, patient
recruitment, study conduct, safety
p-medicine Images, biobank data,
simulation data, HIS
data, clinical trials
data, lab data
• GCP compliance
• International clinical trials process expertise
• Legal & ethical framework
• Cooperation with other research infrastructures
• Use of p-medicine tools for personal medicine clinical trials
BioMedBridges Research data, lab
data, genomic data,
structural data, clinical
data, images
• Standards description and harmonization
• Technical Integration
• Secure access (privacy requirements, legal framework and
data security)

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New forms of collaboration: example
ECRIN and p-medicine
ECRIN
network
International
clinical research
p-medicine
network
Personalised
medicine of cancer
Building upon the
strengths of both
infrastructures,
enabling of mutual
service exchange

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Service integration in Research
Infrastructures
● ECRIN is member in several European FP7 and IMI projects
●
Several EU projects are developing tools and services that can be employed in clinical research and for clinical
trials
– TRANSFoRm, BioMedBridges, p-medicine, EHR4CR
Is there a sustainable, innovative solution to jointly use tools developed in EU projects?
Can service integration be a solution for the employment of services and software tools in research infrastructures?
Use of services and tools to further integration between research infrastructures to get a more deeply cooperation

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Enabling the advancement to deeper forms of
collaboration
Communication Cooperation Coordination Coadunation
Activities:
Networking
Activities:
Service /
tool provision
Activities:
Partnership,
joint tool employment

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Concept of mutual exchange of services
and collaboration
● Collaboration between research infrastructure has to move coordination and
coadunation
● Only with such deep forms of collaboration, the suggested mutual exchange of
services, tools and staff becomes sustainable
● The complexity of modern research makes it necessary that the integration has to
accieved on three levels: business, process and technical
● Business level integration is the most important for sustainability of services
● Organisational structures must be created and maintained

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Three levels of integration

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Concept of mutual exchange of services
and collaboration
● Necessary precondition: Creation of an organizational structure to support sustainability of shared
services
● Sustainability should not be addressed after the project has ended
● The organizational structure should be able to provide
– organizational support, as well as services, training and education that advertises the use of
p-medicine tools to the research community
– organizational support to help in the search for funding and sponsorship opportunities,
provision of data protection and ethics committees, as well as establishing boards and
management capabilities
● The overall aim is to maintain the p-medicine infrastructure and to support investigators in
academic trials and on the other hand to allow other research infrastructures to use personalized
medicine tools and services

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Reciprocal usage for mutual benefits
● Services and tools developed by research infrastructures can be shared and jointly used for
mutual benefit
● Instead of costs and fees, there is mutual use of the developed services
● For example, p-medicine provides data management solution, database and data warehouse
● For example, in exchange to the usage of a service / tool usage:
– ECRIN can help to improve integration of tools into the infrastructure (requirements, process
descriptions, legal requirements)
– ECRIN can help to develop suitable business models
– Business Planning / sustainability plan / continuity plan
– GCP training for developers (Good Clinical Practice, Computer System Validation)
– Knowledge Transfer regarding Computer System Validation
– Knowledge Transfer regarding international clinical trials

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Service provision for ECRIN
● Tools from p-medicine may be installed at an ECRIN data centre
● Tools may be provided as services (e.g. ASP, SaaS, AaaS, IaaS)
● Tools will be configured for every trial anew (e.g. CRF design)
● Sustainability of service provider
● Business model for using tools / services
● Special requirements for using of tools / services in a regulated environment

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Service provision integration (example ECRIN)

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Two types of service provision
● Central service provision
– Central database, local users
– Easy to integrate
– Extension of training, validation
● Local services (EHR data and alerts, HIS data push and pull services)
– Local databases, local service provision, local users
– Difficult to integrate (care zone)
– Future challenge, intense involvement of local investigators, EUCos, GPs, HIS/EHR vendors

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Example of local service provision in an ECRIN trial
CRF

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Sustainability through collaboration
● Collaboration is done by providing jointly a combination of reciprocal services
● Reciprocal services are complemented by the provision of Open Source and fee based tools
where necessary
– For example: our concept includes the combined provision of ObTiMA as a service
(SaaS) and as Open Source version
– The Open Source version is aimed at users that do not need the additional modules, like
biobanking, imaging, adverse events reporting, data pseudonymization and data
warehouse access, but are content with using only the data management functions of
ObTiMA
– The service version provides all additional modules and support against a charge that
will be different for academic or commercial sponsors of clinical trials
Reciprocal services

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Sustainability through collaboration
● The combination of Open Source solutions supported by services provided by companies that help
customers with installation, configuration and troubleshooting is a well-known concept (e.g.
MySQL and Linux)
● In the area of research software for personalized medicine, the absence of a large user
community, the complexity of the IT infrastructure and the multitude of necessary tools
hamper the development of such support companies
– This kind of support must become part of the sustainability concept
● Especially the need to employ p-medicine tools in a regulated environment that is subject
to strict rules and regulations makes it necessary to search for a new support concept
● Our basic idea is to reduce the costs for using personalized medicine services and at the
same time to disseminate its usage in the clinical trials community by employing a reciprocal
exchange of services between p-medicine and ECRIN
Integration of services for personalized medicine

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Concept of mutual exchange of services
and collaboration
● Free combination of personalized medicine tools with other, external solutions
● Improved cooperation capabilities should enable the exchange of resources and people as carriers
of expertise between projects and infrastructures
● Users of tools and tool developers should learn more efficiently from each other
● Collaboration should move from simple networking to service / tool provision and partnership
● Requirement of common standards and joint business models, shared decision making
● Sharing of staff and resources between infrastructures
● Deep integration between infrastructures covers integration on all three levels: business, process
(research) and technical levels
Our concept of mutual exchange of services between p-medicine and ECRIN advances in this
direction of building the basics for partnerships with other research infrastructures

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Reference
Wolfgang Kuchinke, Christian Ohmann, Holger Stenzhorn, Alberto Anguista, Stelios
Sfakianakis, Norbert Graf, and Jacques Demotes. Ensuring sustainability of
software tools and services by cooperation with a research infrastructure.
Personalized Medicine 2016 13:1, 43-55

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Thank you!
Contact:
Wolfgang Kuchinke
Heinrich-Heine University Düsseldorf (HHU)
phone: + 49 (0) 211 81 16142
e-mail: wolfgang.kuchinke@uni-duesseldorf.de
Further information on the project:
https://ecrin.org/ And http://p-medicine.eu/
This presentation contains additional
explanatory material for a workshop