It's a universal challenge for any contract research organization (CRO). How to standardize complex processes but still remain sufficiently agile to serve customers? It seems to be a test that ClinTec International is passing with ease.

President, founder and CEO Rabinder Buttar is a high-profile executive in Scotland, where the firm's headquarters are. Even though her firm was started back in 1997 and currently has 300 employees, Buttar has retained the enthusiasm of a freshly-launched innovator. "CROs have to be entrepreneurial," she says. "We have been extremely entrepreneurial. We have a very fast, flexible business model."

The company and Buttar herself have won a crowded shelf of awards from Deloitte, Ernst & Young, Microsoft and several business associations and newspapers in Britain. In terms of customers, ClinTec says it is working for 11 of the top 25 pharmaceutical firms and doing so in all major regions of the world. She enjoys the travel to operations in 40 countries. "I like to know what is going on on the ground," Buttar says.

In India, the Middle East and other areas, she contends, the company established early offices that other CROs have only recently tried to match. "We've always been forward-looking," she says. "Rather than be followers, we've always been pioneers and leaders going into emerging areas. We were in India before many of the global players came."

Finding good managers for regions new to clinical research is not easy. "Conducting clinical research in these areas is pretty challenging," Buttar says, not just for language reasons but also to avoid cultural missteps. "We have strong local expertise," she adds.

Beyond Labels

Buttar quickly lists a variety of services offered by her firm. But she says the distinction between full service CROs and functional outsourcing providers (FSP) is becoming less cut and dried than it once was. Even "insourcing" (bringing in dedicated teams from ClinTec that work on a project for extended time periods) may work for some clients.

"Nobody can today say which is the best model," Buttar notes. "All of that is in a bit of flux." The sponsor community is basically interested in customized partnerships. Adds Buttar: "There are different models. No one model is perfect for each company." In some cases, she muses, the offerings of CROs must become almost as complex as the sponsor companies they are serving.

Buttar says that big pharmaceutical firms do have high standards. But at least in the U.K., their outsourcing efforts have been a bit limited. She wants all of her people to be thinking across a wider expanse of the planet.

India Presence

In India, Buttar believes, the clinical research industry is mature. "India has emerged," she says. "I wouldn't call it an emerging market. The problems or challenges in India ten years ago are now in the Middle East and Africa. We were there before anyone else. We educated and trained the local investigators. We spoke at many conferences about what the guidances should look like."

As a result, she says, a simplistic cost comparison may indicate that India is no longer an inexpensive location to conduct research. "Cost in terms of man power--the advantage isn't there," she notes. But diabetes, asthma and other industrial-world diseases are widely prevalent, and treatments few. "There are still huge patient populations. If you can shorten the time for drug development by recruiting massive volumes of patients in India, there is still a very big advantage overall," she says.

Cultural Sensitivity

Among the ordinary citizens of India, she believes, cynicism about physicians has yet to materialize, making patients more likely to follow their doctors' instructions. "They trust their doctors generally," Buttar says. "I don't think there is this mistrust issue. [Patients] would feel quite privileged to be able to receive a medication for an indication that might not normally be accessible to them."

In the spring of 2010, ClinTec attracted $12.9 million from Elephant Capital, a Delhi- and London-based investment house. "That's going to spearhead our much stronger growth in India and Asia Pacific," she says. Elephant Capital has ties to India's Dabur group, a consumer and health products conglomerate with roots that go back to 1884.

Buttar is looking forward to working with Elephant and drawing insights from several new board members. The parallels are not precise, but Dabur is a sort of Indian version of Procter & Gamble. Buttar says it's an honor to have ties to Dabur, partly because its controlling family dynasty, the Burmans, are still involved in the firm and highly regarded in India.

Here's an earlier article on India's regulatory environment.

d9A2t49mkex