Three-year-old Raleigh, N.C.-based Clintrax Global, a worldwide contract clinical research services provider focusing on investigative site contract and budget negotiations and payments, announced last week that it has added a new office in Mumbai, India.

Company executives said that Clintrax Global has been operating in the Asia-Pacific region for some time but the new office enables Clintrax to respond to growing demand for investigative site engagement throughout the region. The new Mumbai office adds to the CRO’s network of primary global locations in the U.S., U.K., Mexico and Romania.

“As the global scope of clinical trials expands, it is essential that our company grows with the market in order to provide in-country knowledge and quality service to our clients,” said Elizabeth Easley, vice president of global operations for Clintrax. “Our Mumbai office is the next building block in our global expansion plans.”

Clintrax hopes to use the India office as a hub to broadly service clinical research activity in the Asia-Pacific region. The company reports that it is currently providing clinical research services in Australia, New Zealand, India, South Korea, Taiwan, China, Hong Kong, Malaysia, Philippines, Singapore, Thailand and Japan. 

The overall level of clinical trial activity in the Asia-Pacific region has been strong. In a recent analysis of new clinical trial starts posted in ClinicalTrials.gov last year, CenterWatch analysis reveals that the Asia- Pacific region accounted for nearly one-third of all global clinical research activity. India represents an area where the level of clinical trial activity is low and growth has been well below expectations. Between 2010 and 2014, for example, the volume of new clinical trial starts in India declined by more than 70%. This is due to a number of factors, including lack of infrastructure and a difficult local regulatory environment.

During this period, the number of new clinical trial starts in other parts of the region has been growing. In South Korea, China and Taiwan, the number of new clinical trial starts has increased by 19%, 33% and 15%, respectively, between 2010 and 2014.

“It was an obvious choice for us,” said Clintrax General Counsel Steve Jones. “The growing prominence of clinical development activities in the region made it clear that we needed more staff to service activity in the area in time zones that share the business day with the rest of the region. Mumbai, in particular, is not only the international business hub of India, but is also the home base for one of our long-term employees,” he said.   

The announced global expansion highlights the opportunities within and overall health of the worldwide market for contract clinical research services associated with investigative site engagement. “Clintrax was founded a little over three years ago when several members of our management team left a large, international CRO. We saw a need for niche services that we knew we could implement for our clients with a level of service quality was previously lacking in the industry,” said Jones.

Clintrax acts as a functional service provider organization with specialization in global CTA and budget template development, contract and budget negotiation, investigative site payments, and the placement of embedded dedicated personnel to manage the sponsor’s contract negotiations. “We provide these services to engage with small clinics, large hospitals and multicenter academic institutions in over 60 countries,” said Easley.

“Our use of local negotiators with legal and clinical backgrounds differentiates us from our competitors in that we can provide in-country knowledge not typically offered by a contracts division at a CRO,” added Jones.

The company anticipates opening another office in Eastern Europe within the next 18 months. 

By J. Michael Whalen

This article was reprinted from Volume 20, Issue 01, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »