Rochester, NY – Research Dynamics Consulting Group, a Specialty Care and Critical Care Contract Research Organization (CRO) in Pittsford, NY announced that they have been awarded a major contract for a multicenter Phase II trial by a Biotech company. This trial will be conducted at 25 US sites over the next year.
”This project is exciting as it allows Research Dynamics to expand its already broad therapeutic portfolio of clinical research projects to include a novel gene therapy project” says President and CEO, Lorraine D. Ellis. Ellis goes on to state that gene therapy projects require the CRO to have specialized knowledge on the significant requirements set forth by the NIH and the FDA for their clinical trials. It is necessary to have knowledge on the workings of not only the NIH but also the IBC’s (Institutional Biosafety Committee). “Site management is critical during these studies and our CRO model is designed to meet challenges of these logistically difficult trials. It is these types of challenging trials that get our staff really excited”.
Research Dynamics, founded in 1993, is a privately held Contract Research Organization that provides services and management for Phase I-IV clinical trials for the pharmaceutical, biotechnology, and medical device industries. The company is a full service CRO offering Clinical Trial Management Services, Monitoring, Data Management and Biostatics, EDC (electronic data capture) as well as being a leader in SOP development. RDCG is also consistently recognized as one of the top training companies in the industry. Research Dynamics specializes in providing high quality clinical research services through their experienced staff and, by being early adopters of technology utilized in Clinical Research. The company, headquartered near Rochester, NY, has been named a "Rochester Top 100 Company" for three years. CEO/President Lorraine D. Ellis was named Entrepreneur of the Year 2004 for the use of technology in her company.