Factory CRO, a contract research organisation (CRO) based in the Netherlands and specialising in medical device studies for European and US regulatory approvals, has tied up with business development company AmeriStart to promote the CRO’s services in North America.

Headquartered in Charlotte, North Carolina, AmeriStart provides sales, marketing and strategic business development services to companies looking to break into,or widen their presence in, the US market. It said Factory CRO was the latest addition to a portfolio of “world-class” CROs and other service providers to the life sciences industry.

Established in 1988 and with a base in Bilthoven, Factory CRO is a full-service contract research organisation offering regulatory, preclinical and clinical trial services for medical devices, drug-device combinations, biologicals and cell-based products. The company also has an office in Curacao, Dutch Antilles, which focuses on trials for diabetic wound healing.

Over the past 20 years Factory CRO has conducted clinical studies for more than 50 American medical device manufacturers, noted chief executive officer Dirk Meijer, adding: “Now, with a representative office and AmeriStart’s organisational support, we hope to expand and improve our standing in the USA marketplace”.

Under the contract with Factory CRO, AmeriStart will apply and promote the Dutch company’s expertise to companies seeking both European CE Marks and US Food and Drug Administration approvals, including 510 (k) designations.

“Because Factory understands the regulatory environments across Europe, they are often able to start a clinical trial in as little as eight weeks,” commented AmeriStart’s chief financial officer, David Worrell. “And, Factory has the added benefit of an operational centre in the Dutch Antilles, which has a large diabetic population and is conveniently located in the Eastern US time zone.”