US-based contract research organisation (CRO) CTI Clinical Trial and Consulting Services has opened an office in Raleigh, North Carolina to support biostatistics and outcomes research.

Dr William Irish, the CRO’s vice president, biostatistics and health outcomes research, will lead the initiative, which reflects the growing interest in health outcomes among pharmaceutical and biotechnology companies as well as commitments to Risk Evaluation and Mitigation Strategies (REMS) mandated by the US Food and Drug Administration.

As CTI noted, amendments to the Federal Food, Drug, and Cosmetic Act giving the FDA the authority to require REMS from manufacturers when a drug is first brought to market, or at a later date, came into effect on 25 March 2008.

“With CTI’s focus on the critically ill patient population, we are seeing an increasing number of FDA-mandated REMS programmes for our sponsors,” noted Lynn Fallon, president, consulting services. “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.”

CTI is a speciality drug and market development company focused on critically and chronically ill patient populations in the areas of solid organ transplantation, hepatitis, infectious disease, haematology/bone marrow transplantation and end-stage organ disease including cardiovascular, liver and kidney disease.