Coordination Centre

EMA is working with Erasmus University Medical Center Rotterdam to:

  • establish the DARWIN EU Coordination Centre, and support its work to build a distributed data network; 
  • conduct scientific studies and answer research questions supporting regulatory decision-making by EMA's scientific committees and the European medicines regulatory network;
  • maintain a catalogue of real world data sources for use in the regulatory context and their metadata. 

The DARWIN EU Coordination Centre will be a key user of the future European Health Data Space.

The contract to establish the Coordination Centre was awarded to Erasmus University Medical Center Rotterdam following a call for tender for a service provider published in June 2021. 

The Health Data Science group at the Department of Medical Informatics is leading the Establishment and Operational Phase of the DARWIN EU Coordination Centre. 

Organisational Structure

Organisational Structure

The DARWIN EU CC exists to run studies within its data partner network, overseen by the Study and Network Operations pillars, respectively. These pillars are able to execute studies and onboard Data Partners using tools (such as code and protocols) that have been created by the Development pillar and within an infrastructure that has been created by the Technology pillar. The Technology pillar is also responsible for producing necessary project resources, such as the website and service desk. The overall operation of DARWIN EU is overseen by the Management pillar and with guidance from the Advisory Boards.

Leadership

Prof. dr. ir. Peter R. Rijnbeek

Erasmus MC

Executive Director

Technology Pillar Lead

Prof. Daniel Prieto Alhambra

Erasmus MC, Oxford University

Deputy Director

Development Pillar Lead

Associate Prof. Katia Verhamme

Erasmus MC

Deputy Director

Study Operations Pillar Lead

Carlos Díaz

Synapse Research Management Partners

Management Pillar Lead

Maxim Moinat

Erasmus MC

Network Operations Pillar Lead

 

 

 

Additional Members of the core team

In addition, a large team of data scientists, epidemiologists and programmers are working for the Coordination Centre at Erasmus MC and its subcontractors.

Contributing Organisations

Organisation: Department of Medical Informatics, Erasmus MC

Description: The Erasmus University Medical Center is the largest of the eight university medical centers in The Netherlands. The Department of Medical Informatics, chaired by Prof. dr. ir. Peter Rijnbeek, is an interdisciplinary research group within Erasmus MC that studies new methods for acquiring, representing, processing, and managing data and knowledge in health care and biomedical sciences and has developed land marking infrastructure and software for distributed analysis of electronic health records.

The Health Data Science research line of Prof. Rijnbeek is leading the European OHDSI Chapter, and the European Health Data and Evidence Network (EHDEN). The mission of the group is to produce clinically actionable insights from observational health data by enabling data-driven healthcare. Improved interoperability of data is a necessary pre-requisite for this mission.

Learn more at www.healthdatascience.nl 

Organisation: Clinical Investigation and Translational Science, NDORMS, University of Oxford

Description: The Clinical Investigation and Translational Science division at the Botnar Research Centre (NDORMS, University of Oxford) includes the Clinical Trial Design and Medical Statistics and the Health Data Science sections.

The Health Data Science section, led by Prof Daniel Prieto-Alhambra, includes a multidisciplinary team of over 30 staff and students with expertise in data sciences, engineering, epidemiology, and real world evidence.

Learn more at: link

Organisation: Synapse Research Management Partners

Description: Synapse is a firm specialized in the high quality management of complex research and development projects in the biomedical sector. Synapse partners with national and international organisations, both public and private (pharmaceutical and biotechnology companies, research institutes, academia, hospitals, etc.).

Synapse has a track record on research projects that are highly innovative (open innovation, public private partnerships), large (with several million Euros funding), distributed (built on the collaboration of several institutions) and internationally oriented (with broad expertise in projects funded by the European Commission).

Learn more at https://synapse-managers.com.

Organisation: IQVIA

Description: IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the health sector across the globe. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA delivers powerful insights with speed and agility — enabling life science industry customers to accelerate the clinical development and commercialization of innovative medical treatments and enabling governments to assess and improve public health and population management, all leading to improved patient outcomes. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries.

Learn more at www.iqvia.com.

Organisation: The Hyve

Description: The Hyve is an IT company that provides professional services for open source software. We specialize in the fields of cancer genomics, translational data warehousing, real world data analytics and research data management. Our customers include the majority of top 20 pharmaceutical companies, major academic medical centers in U.S. and Europe as well as biobanks, registries and patient organizations throughout the world.

Learn more at www.thehyve.nl 

Organisation: Odysseus Data Services, Inc.

Description: Odysseus is an established real-world evidence (RWE) solution provider enabling standardized systematic analytics of observational data at scale. Odysseus providing its customers with Software, Data Engineering and Data Science solutions supporting large-scale RWE generation. Odysseus is an active OHDSI contributor in multiple key initiatives and working groups, including design and development of such OHDSI platforms as ATLAS/WebAPI, ARACHNE and ATHENA, OMOP CDM standards, curating and maintaining OMOP standard vocabularies as well as development of OHDSI analytical methods (HADES) and OHDSI distributed network research. Odysseus created the ARACHNE platform with a goal of linking multiple distributed life science and healthcare organizations into a single network to enable standardized federated analytics of observational data.

Learn more at www.odysseusinc.com 

 

Data Partners

The CC has set up an agreement with a growing list of Data Partners to create its distributed network of data sources.

More information about the Data Partners can be found on Data Network page.