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Cincinnati, Ohio~June 23, 2009-
CTI Clinical Trial and Consulting Services announced today the opening of a Raleigh, North Carolina office to support Biostatistics and Outcomes Research. William Irish PhD, Vice President Biostatistics and Health Outcomes Research, will lead this initiative. With the increasing focus on health outcomes, the pharmaceutical and biotechnology industries have an increasing interest in outcomes research. Further, commitments to the new FDA-mandated Risk Evaluation and Mitigation Programs (REMS), will result in more comprehensive programs. “Bill Irish is the ideal person to lead this initiative. He has been a recognized expert by the academic community, as well as in the pharmaceutical and biotechnology industries for almost 20 years,” according to Kevin Schwarz, CTI Senior Vice President Operations.
Amendments to the Federal Food, Drug, and Cosmetic Act 505-1 (A) went into effect March 25, 2008. The REMS portion of the amendment gives the FDA the authority to require manufacturers to submit a REMS when a drug is first introduced to the market or at a post-market date. A REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product to ensure that the benefits outweigh the risks. A REMS can include one, some, or all of the following: medication guide, patient package insert communicative/education plan, elements to assure safe use, implementation systems, and a timetable for REMS assessments. “With CTI’s focus on the critically ill patient population, we are seeing an increasing number of FDA mandated REMS programs for our sponsors. We feel that CTI is uniquely positioned to partner with our sponsor companies, as we have been providing many of these services for more than a decade,” stated Lynn Fallon, CTI President Consulting Services.
About CTI Clinical Trial and Consulting Services
CTI is a specialty drug and market development company offering a full range of services that encompass the entire lifecycle of drug development. These services include regulatory pathway design, clinical trial management, data analysis, medical writing, CME and training program development, market analysis and development and other consulting services. CTI focuses on critically and chronically ill patient populations in the specific disease areas of solid organ transplant, hepatitis, infectious disease, hematology/bone marrow transplant and end-stage organ disease including cardiovascular disease, liver disease and kidney disease. With its combined expertise of clinical knowledge and market experience, CTI is uniquely positioned to incorporate both clinical and market driven endpoints and interpretations to provide results.