Dr Rita Karia, CEO & president, CliniRx Research,
up by the increasing rate of outsourcing by the pharma
companies, the clinical research market has been able to survive the
recession. Therefore, more and more Indian clinical research companies
are going global and expanding their service horizons. India is poised
to register enormous growth in this sector.
In an exclusive
interview with BioSpectrum, Dr Rita Karia, president
and CEO of CliniRx, shares the vision of her organization, the need for
reforms and the current clinical research market scenario in India.
you share some insights on CliniRx as a clinical research organization?
CliniRx is a full-service clinical research organization (CRO) that
provides clinical trial services to pharmaceuticals and biotechnology
companies. The company conducts multi-national clinical trials in phase
II, III, and IV with full-service capabilities and biometrics delivery
capabilities in phase I.
It has offices across the US, Europe and India along
with a good
network of alliance partners across Europe and Russia.
supportive is the government in terms of regulatory approvals?
The government bodies like the Drug Controller General of India (DGCI)
have been very supportive in their contributing roles. CliniRx has been
actively involved in a number of corporate bodies contributing to
guidelines and directives for the CRO industry including joint
activities with the Federation of Indian Chambers of Commerce and
Industry (FICCI) for the formulation of biotech devices directive.
The government needs to support the CRO sector in line with the tax
benefits given to the IT industry, in order to support the growth of
this sector. The support includes tax benefits to R&D
facilities, and tax concessions for training to support development of
the talent pool to encourage larger number of clinical trials in India.
Accreditation of sites and principal investigators, based on globally
accepted criteria is another important aspect for which government
support would be welcome.
good is India as a destination for clinical trials as compared to other
India has a large number of English speaking educated personnel with
relevant skill sets. We have over 600,000 English speaking physicians
in key therapeutic areas with 30,000 new doctors being added every
year. India has a patient mix capable of meeting diverse clinical trial
requirements. The patient recruitment rate is very rapid in comparison
to recruitment in developed countries. A potential area to leverage for
India is the creation of automated and transferable patient records.
In China, the cost of the trial may be low but the regulatory process
is still very lengthy. There has been more growth in the number of
principal investigators involved in clinical trials in India as
compared to China.
is the approach of CliniRx different from others in the clinical
As an organization, CliniRx has strategically positioned itself as a
long-term player right from its inception. It has made substantial
investments for procuring the state-of-the-art software. The most
important investment is for talented workforce and CliniRx has a highly
qualified and skilled team in place. An experienced team of experts
contributes their therapeutic expertise to each project. CliniRx has
worked in over 200 sites in India from tier I, II and III cities and we
are now expanding to involve more tier III towns to help prevent
saturation in particular locations.
are the future plans of CliniRx research?
CliniRx has a strategic intent to expand its geographic footprint
outside India. We are in discussion with companies in the US and Europe
to support our plans. We have gained proficiency in CNS, pain, oncology
and cardiology and are now actively exploring opportunities in
endocrinology and respiratory trials.
— Rahul Koul in New Delhi