In late 2011, Quintiles, the leader in interventional Phase IIIB and IV, acquired Outcome, the leader in observational and real-world research, combining to offer a knowledge-based organization focused on specialization in both observational and interventional research and unmatched expertise and experience in peri and post-approval evidence development.
We have designed, developed, and managed an industry-leading number of real-world and late phase programs across all therapeutic areas. Our programs span the globe, with thousands of sites across North America, Europe, Asia, South America, Africa, and Australia.
In addition to working with life sciences companies, we also partner with many providers and healthcare organizations, specialty associations, hospital associations, pharmacist associations, managed care organizations, state departments of public health, Quality Improvement Organizations (QIOs), and government agencies. In fact, nearly 2,000 healthcare organizations are our direct customers.
We are also actively involved in supporting federal initiatives in regulating and promoting post-approval research. Outcome is leading the Good ReseArch for Comparative Effectiveness Initiative (GRACE Principles), an effort to develop best practice principles for the design and conduct of observational studies of comparative effectiveness. Outcome is also an Agency for Healthcare Research and Quality (AHRQ) DEcIDE Research Center, through which we led the development of the first and second editions of the handbook “Registries for Evaluating Patient Outcomes: A User’s Guide.”
We also serve as a research center for the European Medicines Agency (EMA) ENCePP project, focused on enabling the commission and implementation of PASS by healthcare stakeholders that may provide further insight into the benefit-risk balance of marketed products in Europe. Additionally, Quintiles Outcome is a partner for the EMA PROTECT-EU project, a multinational collaboration of 29 public, private and academic organizations that have come together to develop innovative methods in pharmacoepidemiology and pharmacovigilance.