, managing director, Auriga Research,
is the managing director of Auriga Research. A post-graduate in
pharmaceutical technology from the National Institute of Pharmaceutical
Education and Research (NIPER), Arora has been spearheading the rapidly
growing team of over 150 professionals in the contract research and
testing services business, for the past five years. He has setup a
clinical research center and a second analytical lab, and rapidly grown
the services business, by increasing the scope of services offered, and
a strong commitment to quality and customer satisfaction. He is
actively involved in the development of new services, and the adoption
of new technologies in the organization.
Indian CROs provide small and medium enterprises (SMEs), worldwide,
access to a rich pool of scientific knowledge and capabilities, with
minimum investment. This has made it possible for SMEs to take their
innovations further down the development pipelines, before the need
arises for venture funding, or even selling the technology to bigger
companies. The value-addition greatly enhances the profitability and
helps to further expand such ventures.
Usually when organizations think of outsourcing their research
activities to an Indian CRO the decision is invariably motivated by the
obvious advantages of lower costs and faster recruitment rate for
clinical trials. Today, Indian CROs have a larger value proposition to
offer, which goes beyond these obvious advantages, companies can come
to India with just a concept, and walk away with products ready for the
Indian CROs have been successfully attracting and executing clinical
trials from the world over, because of many tertiary care and specialty
hospitals with high patient numbers and skilled medical specialists. We
have access to a vast disease distribution, and patients that are often
‘therapy naïve’. Our workforce is well-educated, largely
English-speaking and IT-savvy, making it easy to communicate with, and
to utilise the latest IT tools. The strengthened regulatory and
intellectual property environment, has made India the ideal destination
for outsourcing critical research projects.
Over the years, many Indian companies have successfully launched
products in various global markets, and Indian CROs have delivered
numerous and diverse projects for international clients.
Indian CROs have developed state-of-the-art infrastructure for serving
various phases of drug discovery and development. Facilities complying
to, and often surpassing the global regulatory requirements and client
expectations, are available for custom synthesis, chemical
characterization, high throughput screening, preclinical toxicity
studies, drug metabolism and pharmacokinetics, formulation development,
analytical development, contract manufacturing and clinical data
SMEs use these facilities, and depend on CROs to deliver quality data,
without incurring the huge capital investment needed to establish and
maintain such infrastructure. Projects are delivered within tight
budgets, not by cutting corners, but by sharing costs between numerous
projects they handle each year.
We have worked with clients on projects spanning almost the entire
length and breadth of the drug development cycle – for synthesis of the
active pharmaceutical ingredient, its characterization, analytical
development, stability studies, clinical trial formulation development,
in vitro characterization, pharmacokinetic studies, multi-centric
clinical trials and regulatory approvals.
For one of our clients, Alung Technologies, a US-based developer of
extracorporeal respiratory assist devices, partnering with an Indian
CRO was an important strategic decision. “As a company, it was very
important for us to get early experience with our Hemolung device,
before proceeding to a larger clinical study. Being a US-based company,
it was very important for us to find the right partner to work with.
Our CRO, Qualtran Auriga Research, was key to the success of the study.
We have now expanded the trial of our device in Germany, and are
looking forward to obtaining the CE mark in 2011,” says Scott Morley,
vice president of marketing for Alung.
SMEs now rely on their partner CROs, to quickly identify and deliver
solutions to problems. We often develop and offer custom services to
support our clients. Rick Tullis, chief science officer at Aethlon
Medical, says, “Auriga Research helped us in completing our clinical
safety studies in India, with a new technology for treating infectious
diseases, using a blood filtration device. These studies required
highly accurate and sensitive measurement, using quantitative PCR, and
some unusual tests for potential contaminants that most clinical labs
would have difficulty in implementing.”
There is a major shift in the research-based work outsourced to India;
SMEs involved in developing innovative technologies are also harnessing
these potential advantages in India.
Though adopting the model of setting up their own research and
development centers may not always be economically viable; they are
actively partnering with Indian CROs to quickly take their innovative
products to the market.
To conclude, I would like to borrow the terminology of ‘cloud
computing’ from the information technology industry, and say that we
are in the era of ‘cloud research’ where shared resources and knowledge
are provided, on demand, to organizations of all sizes, to drive their
innovations, and create greater value through research and innovation.