IQVIA to Lead Group to Expand Safety/Efficacy Monitoring of Regulated Vaccines and Biologics for the FDA Center for Biologics Evaluation and Research

Feb 06, 2018

DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- IQVIA Holdings Inc. (NYSE: IQV), a company dedicated to using analytics and science to help healthcare stakeholders find better solutions for patients, is announcing a novel alliance with the FDA Center for Biologics Evaluation and Research (CBER) to combine advanced analytics and unparalleled information assets to monitor and assist in the evaluation of safety and effectiveness of various CBER-regulated vaccines, blood products and other biologics.

As part of this important public health collaboration, IQVIA has teamed up with the Observational Health Data Science and Informatics (OHDSI) initiative and its world-class team of healthcare experts and unique data assets from Columbia University, Stanford University, Georgia Institute of Technology, University of California, Los Angeles (UCLA) and the Regenstrief Institute at the Indiana University School of Medicine to enhance the function and outputs of the initiative.

This agreement launches CBER’s Biologics Effectiveness and Safety (BEST) Initiative as a new component of the ongoing Sentinel Initiative to develop new capacity and capabilities within the following areas:

  • Boosting blood safety surveillance in support of FDA efforts to further develop a national hemovigilance program;
  • Evaluating post-market safety and effectiveness for biologic products using innovative approaches such as query tools, machine learning, artificial intelligence and natural language processing; and
  • Assessing health outcomes and evaluating biologic products use.

We believe biologics surveillance will benefit from IQVIA’s near-real-time data and analytics specific to CBER-regulated vaccines, blood and blood products, tissues and other biologics.

IQVIA brings its IQVIA CORE™ to the agreement, leveraging one of the world’s largest curated healthcare information sources, advanced analytics, leading technologies and extensive industry knowledge across diseases, geographies and scientific methods.

“We’re thrilled to be part of this important program to protect public health by fully tapping into data that we generate every day,” said Jon Resnick, president, Real-World & Analytics Solutions, IQVIA. “Putting powerful healthcare analytic capabilities and deep expertise together will help us all benefit from safer medicines and better health outcomes.”


IQVIA (NYSE: IQV) is a leading global provider of information, innovative technology solutions and contract research services focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. IQVIA enables companies to rethink approaches to clinical development and commercialization, innovate with confidence as well as accelerate meaningful healthcare outcomes. IQVIA has approximately 55,000 employees in more than 100 countries, all committed to making the potential of Human Data Science a reality. IQVIA’s approach to Human Data Science is powered by the IQVIA CORE™, driving unique actionable insights at the intersection of big data, transformative technology and analytics with extensive domain expertise.

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 the information that helps their customers drive human health outcomes forward. 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


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