Two large site management organizations (SMOs), Radiant Research and Synexus, are planning expansions into India.

For 13-year-old Radiant, which has 21 sites, this will be its first foray outside the U.S.—though in 2007, the company was bought by two Indian firms, hospital group Wockhardt Hospital, a subsidiary of pharmaceutical company Wockhardt, and ICICI Venture, the venture wing of Mumbai-based ICICI Bank.

Julie McHugh, vice president of Cinncinnati-based Radiant, said instead of partnering with or buying an investigative site in India, Radiant is starting one from scratch.

Synexus, one of two large European SMOs, is also working to make its first push into India. Christophe Berthoux, chief executive of the 25-site company, said Synexus is in “deep discussions” with possible partners in India and wants to be established within the first quarter of 2011.

“It’s a green field,” said McHugh, adding that Radiant’s new site is likely to be based at one of the hospitals already owned by Wockhardt. The company has seven hospitals, most of which are located along India’s western coast, in cities including Nagpur, Nashik, Surat, Rajkot, Bhavnagar and Vashi.

Buying the research arm of a doctor’s practice—which has been a common practice of SMOs in the U.S.—is not an option in India, since most health care takes place in large hospitals and not in doctors’ offices, said McHugh. “They don’t function in the manner we do in terms of private practice,” she said.

India is “where things are going in terms of recruiting patients,” said McHugh, adding that in particular it’s become hard to find treatment-naïve diabetes patients in other, more developed markets including the U.S.

Radiant’s goal is to have the new location up and running within the first half of 2011. McHugh said the plan is to start small, bring staff from India to the U.S. for training, and then send Radiant staff to India to continue training throughout the first year.

Radiant, one of the last remaining U.S.-based SMOs, began diversifying in 2003, adding a CRO component when it acquired the SMO Protocare’s trials and development divisions, which had a CRO. The company now also offers investigative site training. Last June, Radiant sold its early-phase clinical research business unit for $65 million to Covance. Radiant was previously owned by venture capital funds ABS Capital, Oak Investment Partners, Salix Venture and Mayfield Fund.

Synexus, which has a presence in nine countries, prefers its sites do not deliver clinical care. In fact, the Synexus model so far has been to acquire only dedicated research sites. But Ian Smith, Synexus’ founder and medical advisor, says in India that is not
an option.

“We really don’t want to be in general medical care, but if we want to be in India we’re going to have to get over that,” he said. “We don’t think you can divorce clinical care from research there.”

Synexus has been trying to establish a foothold in India for some time, Smith said, either by establishing a green-field site using the Synexus standalone site model or by finding an already existing site with which it is comfortable. Neither has worked yet, but Smith says it’s close.

“India is one of the places where quite a lot of our sponsors expect us to be,” he said. “There’s a massive unmet medical need there; there are literally millions of undiagnosed patients in India who would be very happy to be part of a clinical trial and get some screening.”

Like Radiant’s McHugh, Smith also points to diabetes. In the U.K., he said, five years ago it would be necessary to screen 50,000 patients to find a few hundred with undiagnosed diabetes. Today it is even harder to find such patients. In India, however, about 13% of the population is said to have undiagnosed diabetes.

—Suz Redfearn