Quintiles’ ambitions in the ‘real-world’ data space that helps to inform regulatory and reimbursement decision-making on biopharmaceuticals, as well as efficient planning and design in clinical research, have taken a leap forward with access to electronic medical records (EMR) data representing a total of 40 million patient lives.
The large dataset comes from recent agreements and commitments on multiple sources of de-identitfied patient data, mostly involving US-based medical practices and health systems – although Quintiles expects to add comparable data from other countries in the future.
“When these licensing agreements take effect, Quintiles will have significantly expanded the amount of HIPAA-compliant EMR data its researchers can use to help healthcare stakeholders better understand real-world treatments and outcomes, and for clinical trial planning to enhance drug development efficiency,” noted the US-based provider of integrated biopharmaceutical services.
HIPAA is the Health Insurance Portability and Accountability Act of 1996, signed into law that year by then US President Bill Clinton.
According to Quintiles, the EMR data reflect “a representative sample of the healthcare experiences and detailed clinical treatment of patients across all therapeutic categories”, spanning a “wide variety” of healthcare settings across the US.
The company is also engaged in building up a research and analysis team that can apply its expertise to the new EMR data for both prospective and retrospective observational research.
These experts will supply customers insights for use in outcomes research, health economics, epidemiology, medical informatics, quality reporting, and pricing and reimbursement as well as other areas, Quintiles says.
The aim is to provide customers with knowledge-based services and solutions that can dramatically improve efficiency, productivity and quality across the spectrum from clinical development to healthcare delivery.
The recent agreements, and Quintiles’ plans to add research experts who have worked with the data over a number of years, give the company “a critical mass of high-quality and clinically rich patient-level data to find answers to research questions more rapidly”, commented Dr Richard Gliklich, president of real-world and late phase division Quintiles Outcome.