Mark Miller, PhD, head of Santerra's scientific advisory board, told NutraIngredients-USA.com that most clinical research laboratories were build around the needs and the deep pockets of the pharmaceutical industry. They are usually located in the vicinity of major pharmaceutical companies, in expensive parts of the world.
But the needs of a nutraceutical company with a typically small R&D budget are very difference. Conducting research with an Indian-based organization can cost as little as half as much as it would in the US - and even less for pre-clinical safety and toxicology studies.
Such affordability can be the deciding factor for companies to conduct the trials at all - trials that can lead to publication in a peer reviewed journal and gaining regulatory approvals and market credibility.
Santerra has worked with Mumbai-based Vedic since the former's foundation two years ago, and Dr Miller said that the alliance draws on both parties' strengths. Jayesh Chaudhary, CEO of Vedic Lifesciences, called it a "turnkey approach allows for a seamless connection between R&D and effective marketing."
Aside from the economic benefits, Dr Miller said Vedic has more experience in conducting clinical trials. Going forward it is expected that the majority, but not necessarily all, of Santerra's trials will be conducted in India, depending on their nature.
Santerra, on the other hand, has more experience on the pre-clinical side, and has more expertise in market dynamics. Besides regulatory reasons, the driving force behind trials is often marketing, Dr Miller explained. With more than 100 published studies to his name, he is well-versed in helping them to convert the data into a paper for submission to a peer-reviewed journal or a presentation.
Santerra can also help direct a customer's focus for the trial: "The more focused they can be in a trial the better. We can ensure they are aligned with where they want to be."
Outsourcing to India is nothing new. Low costs combined with high standards in education and professionalism have already led other industries to tap business opportunities there, such as call centers and market research.
Of his company's credentials, Chaudhary said: "All clinical trials projects are conducted in compliance with the highest standards of clinical research as prescribed by ICH-GCP and are open to external audit. All trial protocols are submitted to the Current Controlled Trials for review and registration."
.If there is any resistance to or suspicion of studies conducted overseas, Dr Miller said he expects this to evaporate over time. "The information speaks for itself," he said. "The people who worry are clueless about what it takes to make a good paper". Santerra has become recognised for its expertise in the joint health category thanks to some successful trials, including Reparagen, which is marketed as an alternative to glucosamine. Dr Miller said that this is a facet of market dynamics, and the company is by no means limited to this.
One particularly interesting area may be diabetes; India has a large population of sufferers of this disease, which is causing a drain on health care budgets around the world and which a number of companies are seeking to address with nutraceutical solutions.