Synteract Plans Central Eastern European CRO Office to Open in August 2009


Company News Release

Synteract Plans Central Eastern European CRO Office to Open in August 2009
Clinical contract research organization expands global footprint
SAN DIEGO – June 19, 2009 – Synteract <> , Inc., a full-service contract research organization (CRO <> ) dedicated to meeting the clinical research, technology, and safety needs of biotechnology, medical device, and pharmaceutical companies, will open a Central Eastern European office in Prague, Czech Republic, in late summer 2009 to better serve the global clinical trial needs of its clients. The separate business unit will be headed by Kristi Clark, currently the senior director of Project Management and Global Business Operations at the headquarters office in Carlsbad, California. The office will offer regulatory, site management/monitoring, pharmacovigilence and project management services; all services, including data management, biostats (including CDISC) and medical writing are available to clients globally.

Prague, a city of more than a million people, was chosen due to its centralized location, friendly business environment and sound economic structure, as well as its value as an excellent area for patient recruitment. Many later stage and larger trials sponsored by U.S. companies are becoming international, with at least some of the study sites located outside the U.S. With the pool of clinical trial patients dwindling in the United States due to the availability of good health care and heavy competition, an international office has become a critical offering for multiple phase programs.  Key therapeutic areas in which Synteract specializes, such as oncology, will benefit from the additional location. The new office, in combination with other recent efforts employed, such as a new training program, strengthens the company’s clinical position.

According to CEO Ellen Morgan, Synteract is responding to requests from clients to expand internationally. “Our goal is to provide our clients with the same flexibility, guidance and responsive service for their multinational trials that they have become accustomed to when working with us domestically,” says Morgan. “We decided that this year is the right time to move forward to provide the one-stop shop and broader services they need. Having Kristi on the ground in Europe will also help us to evaluate additional potential partners who fit our model.”

Kristi Clark will take on the role of managing director to build the office. Having been with Synteract for almost four years, she is well-versed in the high quality culture of service that Synteract embodies. With more than 19 years of industry experience, which includes 12 years of global trial experience in the biopharma industry, Clark’s background has spanned the full scope of studies, from start-up to project closeout and review in several therapeutic areas including oncology, cardiovascular, central nervous system and ophthalmology. She is expert at tackling slow enrolling studies and other difficult study challenges by employing a risk mitigation strategy that involves strategizing with clients and vendors.  She holds an MBA with an emphasis in Healthcare Administration, and will be responsible for green-fielding the new office, hiring employees, monitoring project management and establishing affiliate relationships.

“We will maintain the same level of service in our Central Eastern European office that we now offer in our U.S.-based offices, yet still retain our corporate culture overseas,” says Clark. “Having key Synteract employees transferred from the U.S. to the Prague office confirms our commitment to quality and will help our clients have more confidence that their international trials will meet the standards they expect from our company, to support them with continuity from phase one to four trials.”

The Eastern European office is the first major step in Synteract expanding its global footprint. The company also is looking at possible acquisitions in Europe and India in 2010 and beyond. In 2007, Synteract opened an office on the East coast in the Research Triangle Park area of North Carolina, and in 2008, it added a Phase one unit capability through Vince & Associates in Overland Park, KS. Recently, it began offering consulting services to venture capitalists who fund biotechs as well as to the biotechs that receive the funding.

About Synteract

Established in 1995 by two veterans of the pharmaceutical industry, Synteract <> is a privately held, full-service contract research organization, dedicated to meeting the clinical needs of biotechnology, medical device, and pharmaceutical companies. The company’s mission is to provide high quality yet personal service, working closely with drug and device sponsors as though a department within their company.  Headquartered in Carlsbad, California, with a second office in Research Triangle Park, North Carolina, Synteract has clinical trial expertise in a wide range of therapeutic areas, including a strong emphasis in oncology, central nervous system (CNS), cardiovascular disease, and ophthalmology. Information, <> or (760) 268.8200.

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