Call for tender to establish the Coordination Center of the DARWIN EU launched

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published a procurement procedure today for setting up a framework to support better decision-making throughout the lifecycle of medicinal products with timely, valid and reliable evidence from real world healthcare data sources on the use, safety and effectiveness of human medicines, including vaccines.

This initiative, named Data Analysis and Real World Interrogation Network (DARWIN EU), will deliver a set of services that will include the establishment and operation of the DARWIN EU Coordination Centre, the onboarding of data partners, the establishment of connectivity to the European Health Data Space (EHDS), the maintenance of a continually enlarging catalogue of accessible observational data sources suitable for use in the regulatory context and the execution of  all steps of high-quality non-interventional studies to address regulatory questions (from development of scientific protocols, interrogation of relevant databases, data analysis and interpretation and reporting of study results).

The HMA/EMA Big Data Task Force recommended developing DARWIN EU in its final report of January 2020, and the creation of DARWIN EU is included in the EMA-HMA Big Data Steering Group workplan and the EMA Network Strategy to 2025.

The purpose of this tender is to select the contractor that will establish the Coordination Centre and that will deliver and operate  the set of technological and methodological services under the instruction and supervision of EMA for the provision of access to healthcare data and the execution of scientific studies to support decision-making of the EU regulatory Network.

The deadline for submission of requests to participate is 5 July 2021.

Related information: Procurement at EMA