New CRO launches with a focus on hard-to-reach markets and resource-limited settings

12-Apr-2019 - Last updated on 12-Apr-2019 at 15:50 GMT

(Image: Getty/Suwaree Tangbovornpichet)

NC-based FHI Clinical last week officially launched as a new full-service contract research organization with a global team the “right size” to adjust when needed, says CEO.

FHI Clinical is a part of FHI 360, a Durham, NC-headquartered nonprofit “human development” organization, which also recently launched two subsidiaries, FHI Ventures, and FHI Partners, an investment firm and nonprofit creating strategic partnerships, respectively.

The company has been conducting research since 1971 as part of its parent company, which has a nearly 50-year history in clinical research and experience growing CROs. As of last week, the global research services (GRS) operating unit of FHI 360 became an independent, commercial subsidiary.

As part of the launch, Ted FitzGerald, after more than a decade with the organization, transitioned from director of GRS at FHI 360 to president and CEO of FHI Clinical.

“The sponsors we work with are looking for CROs with global reach, yet intimate knowledge of the site and investigators who can make their trials successful. At the same time, they need flexibility which often seems like a trade-off to working with a larger CRO,” said FitzGerald, who this week is in Asia discussing the company’s launch.

“We have the benefit of being both global and the right size to adjust when necessary,” he told us.

The company’s team has native-level fluency in at least 18 languages with a presence in Africa, Asia, Europe, Latin America, and North America, to provide in-country technical, regulatory, and cultural knowledge, said FitzGerald. The CRO will offer full-service solutions and services, including clinical operations, regulatory, quality assurance (QA) and post-marketing.

“We specialize in managing complex clinical research specifically in hard-to-reach markets and resource-limited settings often neglected or overlooked by the industry,” FitzGerald added. While the organization has worked across several therapeutic areas, its focus is on infectious diseases including tropical diseases, emerging and reemerging diseases, as well as pediatric studies.

The contract research organization (CRO) is made up of 50 staff members across 15 countries and also has access to FHI 360’s global network of more than 4,000 professionals in more than 50 countries.