A new clinical research organisation specialising in the medical device sector, Symbios Clinical, has been set up in the USA.

In an interview with PharmaTimes, one of the co-founders of Symbios, Ethan Rooney, said the driver for setting up the business came from disappointing experiences he had when working with CROs in his earlier position in clinical management within the medical device industry.

“We realised that there was a real demand for specialised experience in this industry,” he said. “We felt that we could build a company that was more responsive and customer friendly, by reducing the learning curve medical device manufacturers often experience when outsourcing clinical trial management.”

The company offers clinical trial management services, including study design, site activation, data management, monitoring, data analysis and publication support, and has been launched with the aid of $500,000 in start-up financing.

The company’s primary specialty is in the conduct of large-scale, Phase IV outcome studies, although it has the capacity to handle trials of any size, according to Rooney, and it has particular expertise in implantable devices, a broad category which includes cardiac defibrillators, pacemakers, and orthopaedic implants, among other products.

The implantable medical device market is currently valued at $23 billion in the USA alone and forecast to grow by 10% a year through 2009, according to market research data from Freedonia.

“We understand that the details and nuances associated with implantable devices, which are extremely important for proper planning and conduct of a device trial,” he said.

“There are other CROs that claim to specialise in medical devices, but we intend to differentiate ourselves by providing unparalleled customer service and leverage our industry expertise to deliver results.”

Symbios is located in Shoreview, Minnesota, and began operations on June 5. It is currently adding staff and is looking to hire a clinical study manager as well as clinical research associates. Rooney said the firm is already working with ‘large and small’ medical device manufacturers, including Fortune 500 companies, although the identity of these firms has not been made public.