IQVIA Selected to Support EMA’s DARWIN EU® Coordination Centre Initiative

Rhea-AI Summary

IQVIA (NYSE:IQV) has secured a contract from the European Medicines Agency (EMA) to provide analytics services for the DARWIN EU® Coordination Centre, managed by Erasmus University Medical Center Rotterdam. This initiative aims to establish a pan-European network of real-world healthcare data systems, enhancing the regulatory decision-making process for drug safety and effectiveness. Over two years, IQVIA will contribute technical expertise and management for pharmacovigilance data, improving data standardization and accessibility for regulatory agencies.

Positive

• IQVIA awarded a contract by EMA for analytics services, enhancing its reputation.
• Establishment of the DARWIN EU® Centre supports faster regulatory decision-making.
• IQVIA's involvement in a competitive bidding process reflects its strong expertise.

Negative

• None.

AMSTERDAM--(BUSINESS WIRE)-- IQVIA™ (NYSE:IQV), a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, today announced that the European Medicines Agency (EMA) has awarded a contract to Erasmus University Medical Center Rotterdam to provide analytics services to the DARWIN EU® Coordination Centre which IQVIA was selected to support. IQVIA will also work alongside the University of Oxford, Synapse, The Hyve, and Odysseus Data Services.

The Coordination Centre for the Data Analysis and Real World Interrogation Network, or DARWIN EU®, will develop and manage a network of real-world healthcare data sources across the EU to conduct scientific studies requested by medicines regulators and eventually as requested by other stakeholders. The centre will accelerate access to high-quality real-world evidence for the use, safety and effectiveness of drugs across the EU in support of the EMA’s regulatory decision-making.

By establishing a pan-European network, the DARWIN EU® will set standards for federated data analysis using a common data model to support the deeper integration of secondary data into regulatory decision-making as a complement to prospective clinical trials. This approach will respond to the increasing need for faster multi-country real-world solutions, as demonstrated by the COVID-19 pandemic, and will provide regulators, health technology assessment bodies and payers with a deeper understanding of diseases and therapies, as well as more tailored guidance to help clinical trials sponsors accelerate decision-making.

IQVIA will contribute technical expertise and information management solutions to enable regulatory-quality analytics of healthcare data gathered from different sources across Europe. IQVIA will contribute to a two-year design plan, as well as three years of pharmacovigilance data network management and analysis services, with the first datasets already onboarded this year. This will give EMA and national regulatory agencies access to richer and more standardized datasets, enabling agency analysts to use the capabilities of real-world technologies to produce more comprehensive insights from the data.

The Coordination Centre was selected in a competitive bidding process involving leading real-world research organizations from across Europe, and the award was based on the group’s depth of experience and knowledge of technology solutions.

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 79,000 employees, IQVIA conducts operations in more than 100 countries.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors, and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220330005901/en/

Nick Childs, IQVIA Investor Relations (nick.childs@iqvia.com)

+1.973.316.3828

Tor Constantino, IQVIA Media Relations (tor.constantino@iqvia.com)

+1.484.567.6732

Source: IQVIA

FAQ

What is the significance of IQVIA's contract with the EMA?

The contract enhances IQVIA's role in providing real-world data analytics to support drug regulation in Europe.

How long will IQVIA manage the data network for the EMA?

IQVIA will manage the data network for two years, focusing on pharmacovigilance and analytics.

What is the DARWIN EU® Coordination Centre?

It is a network designed to analyze real-world healthcare data across Europe for regulatory purposes.

What companies are collaborating with IQVIA on this project?

IQVIA is working with Erasmus University Medical Center, University of Oxford, Synapse, The Hyve, and Odysseus Data Services.

What are the expected outcomes of the DARWIN EU® project?

The project aims to provide faster, more comprehensive insights into drug safety and effectiveness for regulators.