Excel Life Sciences, a US-based clinical trial management
organization offering comprehensive clinical trial and site management
services with 25 operational locations across India, claims to have
trained 1,500 clinical research personnel in India.
In an exclusive interview with BioSpectrum
Vijai Kumar, President and CMO of Excel Life Sciences, shares his
views on various aspects of clinical research related to government
volunteers in India.
Could you tell us about the growth and
expansion plans of Excel Life Sciences?
We have been maintaining a philosophy of good site management to ensure
data integrity and data quality. As an organization, ELS in India has
grown from being a three person company to 100 member organization in
just three years. We have trained over 1,500 clinical trial research
personnel in India. We have participated in 20 NDA submissions as a
team. Financially, we have grown considerably with 413 percent growth
in 2007-08 and 113 percent in 2008-09 and our expected growth for
2009-10 is 215 percent.
We are cautious about expansion. We would establish our credentials
that good site management is vital for good quality data. We have
established a successful partnership with Zürich-based PFC Pharma
Focus Consultants for Europe and Israeli markets. This partnership
helps us provide end-to-end solutions for our US and European clients.
What are your views on the government
support to clinical research industry in India?
Government has the right intentions but implementation has not been
uniform. We need to have clear set of guidelines and there is always a
room for improvement.
Also, I feel the need to provide overseas exposure to the regulators.
They should get hands on experience of the functioning of international
model of FDA regulatory system. There is also need to train them in
undertaking site inspection. I am glad they have made a good beginning
in this important functional area and the process has been initiated.
What according to you are the things
most needed for the promotion of clinical research industry?
I believe FICCI, CII and other industry associations, and all stake
holders in drug development and clinical research - national regulatory
agency, IRBs, pharmaceutical industry, CROs, medical professionals and
patients should have ongoing interaction to identify issues confronting
different stake holders and address them openly and in a time bound
Society at large has a number of misconceptions of clinical research.
All the stake holders need to create an atmosphere for the media to
collaborate to educate the community about benefits of participating in
It will be useful to provide opportunities for patients to share their
experience of participating in clinical research to the community. This
could be through print, electronic media and personal meetings. Social
organizations like Rotary and Lions also have an important role to play
in disseminating positive information about medical research in general
and clinical research in particular.
Where do you see ELS after next five
years and what is your prediction for growth of the industry?
In the next five years, ELS will expand its footprint into promising
new geographic areas where ELS can make a difference and spread the
awareness of global clinical research across India. The clinical
research industry in India is also poised to make remarkable progress,
with growth and competition, consolidation and maturation has to take
place. We are likely to see mergers and acquisitions in this space in
the not too distant future.
So long as we do all we can to build the trust and confidence of the
community in clinical research, we will continue to provide
opportunities to global biopharmaceutical and medical device industry
to bring their products expeditiously to the market, and we can
assure them of the data quality and data integrity generated in India.
Rahul Koul in New Delhi