Electronic Health Records Systems for Clinical Research
Electronic Health Records 4 Clinical Research


Start Date
End Date
IMI1 - Call 2
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
7 194 044
EFPIA in kind
7 555 883
1 893 502
Total Cost
16 643 429


Current medical needs, the growth of targeted therapies and personalized medicines and escalating R&D costs result in formidable cost pressures on healthcare systems and the pharmaceutical industry.Clinical research is also growing in complexity, labour intensity and cost. There is a growing realization that the development and integration of Electronic Health Record systems (EHRs) for medical research can: enable substantial efficiency gains make Europe more attractive for R&D investment provide patients better access to innovative medicines and improved health outcomes.

EHRs can now be designed to seamlessly integrate with existing research platforms and healthcare networks to create opportunities for many stakeholders, including the pharmaceutical and bio-pharma industries.

However, key challenges are compliance with various ethical, legal and privacy requirements (and acceptance by the general public, patients, and medical professionals), providing a platform that works across many EHR systems and is sustainable within a scalable business model. A 4-year project, EHR4CR will involve a team of recognised European academic and industrial partners.

The project will build a platform to enable the use of EHR for more efficient medical research and run pilots (on interoperability, security, data quality, data storage solutions, organisational issues,accreditation and certification, etc) to demonstrate the viability and scalability of an EHR4CR business model.

The EHR4CR project supports the IMI strategic agenda with an information gateway solution to enhance clinical research efficiency and innovation. A key IMI aspect is the development of a knowledge management capability that can, for example, provide information management support for other research on personalized medicines, now an IMI 2010 call topic. EHR4CR also supports other IMI R&D projects by enabling the use (and reuse) of large amounts of health data – in an ethical and cost-effective way.

The EHR4CR project consortium draws its expert partners from academia, with 20 organisations and 4 SMEs working with 10 EFPIA companies and is an example of the scale of collaboration made possible through IMI.

Achievements & News

Sign up for the i-HD conference on realising the value of health data
October 2018

Registration is open for the annual conference of the European Institute for Innovation Through Health Data (i-HD) in Gothenburg, Sweden on 19-20 November. The theme this year is ‘Realising the value of health data, showcasing practical examples from research and healthcare’, and the conference will showcase how routinely collected health data (real world data - RWD) can be used to derive important knowledge insights###, possibly uniquely from large scale data, and how these insights can and should impact on decision making and healthcare strategy. There will be sessions on:

  • pragmatic clinical trials - their role, methods and tools, results and impacts;
  • international observational health data networks – communities and projects;
  • learning health systems – the global landscape;
  • hospital-led and patient-led initiatives to use health data to improve outcomes;
  • a debate on the acceptability conditions for real world evidence - to inform regulatory decision making.

A number of IMI projects will present their results, namely EMIF, ADVANCE and GETREAL. i-HD was itself born out of the IMI project EHR4CR.

EH4CR outcomes could reduce the time needed to set up and run clinical trials
November 2017

Any new treatment, diagnostic test or medical intervention must go through clinical trials to demonstrate that it is safe and effective. Large-scale trials require hundreds or even thousands of patients that meet specific criteria. They must have the particular condition that is under investigation – but there may be other restrictions such as age or previous treatments. Finding a group that fit all these criteria can be time-consuming and expensive. To solve this problem, IMI’s EHR4CR project set out to find a way to allow researchers running clinical trials to search medical records in hospitals across Europe to discover the number of potentially suitable patients per hospital. Through collaboration between pharmaceutical companies and 11 hospitals in five countries, EHR4CR developed a way of assessing the number of potential trial patients from the hospitals’ electronic records while maintaining the privacy of sensitive personal data. ### “We knew it was possible on a one-to-one basis to get data from a single hospital to find out if they have any suitable patients,” says project coordinator Mats Sundgren from pharmaceutical company AstraZeneca. “What we did was to research and develop a scalable solution for using electronic health records across many hospitals in Europe without jeopardising or violating data security.” Following the completion of EHR4CR, the platform has launched as a commercial service called InSite developed by specialist data company Custodix – one of the former project partners. This enables scientists to search electronic medical records for suitable patients within a growing network of European hospitals treating millions of people, without seeing any personal information about them. It is predicted that using the platform to speed up trial planning and recruitment could reduce the time taken to set up and run a clinical trial by three to six months.

Save the date! Health data event on 10 March 2016
November 2015

The inaugural conference of the European Institute for Innovation through Health Data (i~HD) will be held in Paris, France on 10 March 2016. i~HD is a non-profit institute that was born out of the IMI electronic health records project EHR4CR and other related projects. Its mission is to guide and catalyse the quality, interoperability and trustworthy uses of health data, for optimising health and knowledge discovery.###

This inaugural conference will mark the launch of a novel European platform to support multi-centre clinical research. This operational platform, the result of EHR4CR, can connect securely to the data within multiple hospital electronic health record (HER) systems and clinical data warehouses across Europe, to enable a trial sponsor to predict the number of eligible patients for a candidate clinical trial protocol, to assess its feasibility and to locate the most relevant hospital sites. Also on the agenda is IMI’s EMIF, Europe’s largest ‘big data’ project in health. The conference will also spotlight the challenges and state-of-the-art approaches to improving the quality and interoperability of clinical data. i~HD will play an important future role in the development and quality labelling of interoperability standards, bringing together clinical and research domain experts, with patients, to help ensure that future standards support patient care, learning health systems and clinical research.

The event is invitation only; those who wish to attend should express their interest via this form.

New EHR4CR video
April 2014

IMI’s EHR4CR project has produced a new animated video detailing the project’s main goal: to significantly improve healthcare research by advancing the ability of industry and academia to securely analyse de-identifed electronic health records###, strictly  complying with data privacy, ethical, regulatory and legal policies. The project will also enable hospitals to participate more efficiently in more clinical trial programmes and, ultimately, ensure faster access for patients to safe and effective medicines.

  • Watch the video to learn more about how EHR4CR will reach its goals.
  • Learn more about the project

EHR4CR video
March 2013

IMI’s EHR4CR project has produced a video explaining how the project works. The goal of EHR4CR is to build, validate and deploy a Europe-wide innovative technological platform to re-use data from electronic health records (EHRs) for clinical research ### purposes while ensuring compliance with all applicable legislative, regulatory, ethical and privacy protection requirements and policies. The video can be downloaded from the homepage of the EHR4CR website.

Stakeholders in favour of using electronic health records for clinical research, EHR4CR project survey shows
November 2011

An overwhelming majority (95%) of stakeholders are in favour of using electronic health records (EHR) in clinical research, according to the results of a recent survey run by IMI project EHR4CR (‘Electronic health records for clinical research’).### The goal of the project is to come up with a platform and business model to enable the re-use of data from EHRs for clinical research in Europe. The EHR4CR team set up the survey to identify opportunities and challenges in this area. The survey gathered around 200 responses from researchers in academia, the pharmaceutical industry, EHR system providers, patients’ organisations and others. Most highlighted complying with legislative, regulatory, ethical and privacy requirements as a top priority for the successful use of EHR services for clinical research. ‘The results of this survey confirm a high interest in re-using EHR data for clinical research with the objective to optimise drug development efficiency and access to innovative medicines in Europe,’ the project team states. ‘This survey provides valuable information towards achieving the development and implementation of EHR4CR services and of a sustainable and scalable business model.’ The team’s findings will be published in a forthcoming issue of iHealth Connections.

Participants Show participants on map

EFPIA companies
  • Amgen, Brussels, Belgium
  • Astrazeneca AB, Södertälje, Sweden
  • Bayer Pharma AG, Berlin, Germany
  • Eli Lilly and Company Limited, Basingstoke, United Kingdom
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
  • Novartis Pharma AG, Basel, Switzerland
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
Universities, research organisations, public bodies, non-profit groups
  • Assistance Publique - Hopitaux De Paris, Paris, France
  • CDISC Europe Foundation, Brussels, Belgium
  • Ethniko Kai Kapodistriako Panepistimio Athinon, Athens, Greece
  • European Institute For Health Records, Lille, France
  • European Molecular Biology Laboratory, Heidelberg, Germany
  • European Platform for Patients Oganisations, Science and Industry, Leuven, Belgium
  • Friedrich-Alexander-Universitaet Erlangen Nuernberg, Erlangen, Germany
  • Heinrich-Heine-Universitaet Duesseldorf, Düsseldorf, Germany
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
  • King'S College London, London, United Kingdom
  • Medical University of Warsaw, Warsaw, Poland
  • The University Of Edinburgh, Edinburgh, United Kingdom
  • The University Of Manchester, Manchester, United Kingdom
  • Tmf - Technologie Und Methodenplattform Fur Die Vernetzte Medizinische Forschung Ev, Berlin, Germany
  • University College London, London, United Kingdom
  • University Of Dundee, Dundee, United Kingdom
  • University Of Glasgow, Glasgow, United Kingdom
  • Université de Rennes 1, Rennes, France
  • Westfaelische Wilhelms-Universitaet Muenster, Münster, Germany
  • eClinical Forum Association, Friesenheim, France
Small and medium-sized enterprises (SMEs)
  • Custodix NV, Sint-Martens-Latem, Belgium
  • XClinical GmbH, Munich, Germany
Patient organisations
  • Les hôpitaux universitaires de Genève, Geneva, Switzerland
Third parties
  • Consept Consulting SARL, Friesenheim, France
  • Neptunus Data Aktiebolag, Saltsjöbaden, Sweden


Project coordinator
Mats Sundgren
Global Clinical Development, AstraZeneca
Managing entity
Dipak Kalra
Managing entity
Prof. Dr. Georges De Moor
European Institute for Health Records
For press inquiries