INC Research Holdings, a global Phase I to IV contract research organization, is commemorating its milestone of managing the Antiretroviral Pregnancy Registry (APR), the largest and longest-running pregnancy exposure registry of its kind that has enrolled more than 20,000 prospective pregnancies from 70 countries over the last quarter century. As a voluntary, international study designed to collect data on pregnancy outcomes, the APR is the primary source for evaluating the safety of antiretroviral (ARV) drugs used in pregnancy. The APR is a collaboration of 26 manufacturers of more than 45 brand and generic medications. The long-standing success of the APR is due, in part, to the broad participation of healthcare providers that are committed to improving the health of this patient population, and in part due to the outstanding contributions of the scientific advisory committee and sponsor companies as they join together for this common cause.
“As INC Research celebrates this milestone, we take great pride that the APR has resulted in greater transparency and safer usage of drug treatments, ultimately improving the care for HIV-infected pregnant women and their babies,” said Bill Row, Vice President, Real World Strategy, Late Phase at INC Research. “Our work with registries is an excellent example of how our Late Phase team has combined our therapeutic expertise and operational prowess to improve knowledge about medication safety in the post-approval, real-world clinic setting. Furthermore, our unparalleled experience with registry design and implementation has resulted in the opportunity to advance the methods and processes to better meet our sponsors’ needs.”
The APR is a purpose-built, collaborative project with multiple pharmaceutical manufacturers and an independent advisory committee with the goal of collecting, evaluating and disseminating information to inform decisions about the risks and benefits of ARV therapy in HIV-infected pregnant women and their newborns. The APR adheres to FDA guidance to monitor and assess the safety of ARV therapy during pregnancy, providing clinicians and patients with a greater understanding of their potential risk. Recognized as a leader in this industry, INC Research was the only CRO invited by the FDA to present on pregnancy registry best practices and participate at their 2014 forum, “Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products during Pregnancy in the Post-approval Setting.”
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