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Metroplex Clinical Research Center (MCRC) and Rheumatology Associates announced the opening of their new 22,500-square-foot complex featuring top-rated rheumatology services and world-class Phase I-IV research services under one roof.
Founded in 1984 by respected rheumatologists Dr. Roy Fleischmann and Dr. Stanley Cohen, both the practice and MCRC have deep roots in North Texas. For more than 30 years, MCRC was a mainstay of medical discovery on the campus of UT Southwestern at St. Paul Medical Center. Conversely, Rheumatology Associates is one of the oldest rheumatology practices in Dallas.
The clinical team comprises 10 board-certified physicians and two nurse practitioners, as well as a designated team of critical care professionals with extensive experience in clinical research. Certified coordinators, regulatory specialists and laboratory technicians are also part of the staff. Together, they've completed more than 1,000 Phase I-IV clinical studies in several therapeutic areas, including rheumatology, osteoporosis and musculoskeletal pain.
Phase I studies represent a critical starting point in the drug development process. During a Phase I study, doctors test an investigational medication or therapy in a small group of people to evaluate its safety, determine a safe dosage range and identify side effects. Based on the information from these studies, dosing is determined for later stage studies which involve several hundred patients.
MCRC's Phase I expertise encompasses first human dose; first in disease; maximum tolerated dose in healthy patients; biologicals, including vaccine and monoclonal antibodies; clinical pharmacology (PK/PD) Phase Ia, Ib; drug interaction; and early efficacy studies (Phase IIa).
The state-of-the-art facility features 22 exam rooms, two spacious infusion rooms, a full-service X-ray department, and a CLIA-certified laboratory. Within the 5,000-square-foot Phase I unit are ACLS-certified critical care staff, 24-hour physician coverage, overnight accommodations for up to six patients, and recreation and lounge facilities. Spacious sleeping rooms include wireless Internet, television and personal DVD players. The Phase I unit will be expanded in 2010 to increase the inpatient capacity to 12.