Segal Institute for Clinical Research has experience in conducting a variety of Phase I studies, including bioavailability, bioequivalency, drug-to-drug interaction, QTc interval evaluations and Pharmacokinetic studies. Segal Institute's Investigators and staff are capable of conducting these studies in special populations and manage a broad range of patients who can be rapidly enrolled in clinical trials.
Segal Institute's Phase I studies are solely conducted in South Florida at Atlantic Shores Hospital, a 74 bed free-standing psychiatric hospital. Segal Institute Principal Investigators conduct Phase I studies in special populations on a segregated, 18-bed locked unit. A team of experienced coordinators, research assistants and phlebotomists support the Segal Institute Investigators 24-hours a day, seven days a week to ensure patient retention and safety. An on-site pharmacy and research offices with designated areas for testing, consenting, lab draws, physical exams and ECGs enable the team to take on a variety of Phase 1 studies. The site is equipped with specialized equipment including a -70° C freezer with an alarm system, -20° C freezer, refrigerators, centrifuges, refrigerated centrifuges, reclining shares for infusion therapy, ECG machines, stadiometer, glove box and synchronized wall clocks throughout the unit. Common areas have televisions, movies, ping pong and pool tables and arts and crafts activities. Additionally, subjects can enjoy the site's locked, lushly landscaped outdoor courtyard with volleyball nets and basketball courts. In 2009, Segal Institute set up a 4-bed sleep lab directly on the unit in order to conduct highly specialized polysomnography studies involving acute populations. All Phase 1 studies are conduced in strict adherence to Segal Institute's Phase 1 Standard Operating Procedures.
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