Phlexglobal, a U.K.-based CRO that specializes in software and services that help drug sponsors manage clinical trial documents, has opened an office in Carlsbad, Calif., as the company looks to expand its business operations into the United States.

The new office, which is Phlexglobal’s first location outside of Europe, employs six people, a number that newly appointed president, Aidan Nuttall, expects to double before the end of the year. Depending on how fast the U.S. business grows, Phlexglobal hopes to open a second office on the East Coast in the future.

Phlexglobal, which was founded in 1997, announced its expansion into North America this week at the annual Drug Information Association (DIA) meeting in Washington, D.C.

Phlexglobal’s decision to expand into the U.S. was driven by requests from two of its global biopharmaceutical clients.

The two drug sponsors, which had hired Phlexglobal to centralize their clinical trial files in Europe, both indicated they wanted the U.K.-based CRO to have a presence in the United States.

“While client demand was the stimulus, having set-up the company here and becoming aware of the U.S. market, we will be looking to not only service those clients, but also to grow the company,” said Nuttall, who heads the U.S. operation. Before joining Phlexglobal, Nuttall co-founded Abingdon Life Sciences, where he retains his position as president, and was former president of Chiltern’s U.S. office. “It was the client, rather than the opportunity, that started it. But the opportunity is vast and we will move toward that opportunity,” Nuttall said.

From the new U.S. location, Phlexglobal will offer its electronic trial master file (TMF) solution, which is called PhlexEview. The system centralizes documents required for a TMF, which includes all data associated with a clinical trial, electronically backs up the information, and makes it accessible electronically to drug sponsors, CROs or anyone else granted permission to view the documents. PhlexEview encourages a continual collection of clinical trial documents required for a TMF rather than assembling the documents at the end of a study. “With a lot of companies, it is an accepted fact that although the collation and the organization of these documents should be an ongoing process, sometimes it is done at the end of the study when everyone remembers they forgot to put it together,” Nuttall said.