- Dr Rita Karia, CEO & president, CliniRx Research, New Delhi

Geared 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.

Can 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.

How 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.

How good is India as a destination for clinical trials as compared to other Asian countries?
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.

How is the approach of CliniRx different from others in the clinical research market?
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.

What 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