Ganpat University (Recognized by UGC u/s 2(f)) collaborates with Xcellon School of Healthcare, as Industry Training Center.

New Delhi, Jan 21 (IANS) Eying a sizeable share of global clinical trials market, Fortis Healthcare, a private hospital chain in India, Thursday said it will now focus more on clinical research across its network in fields like oncology, neurology, nephrology and orthopaedics.
Currently, Fortis has been active in clinical trials in the field of cardiology.

Fortis Healthcare chief Shivinder Mohan Singh said: 'This initiative reaffirms our commitment to continuously enhance healthcare services in the country and to provide better solutions to our customers. We believe this will significantly contribute to India's vision of meeting the global standards of healthcare delivery.'

The company has plans to include clinical researches in the domains of oncology, neurology, nephrology and orthopaedics. The company will enrol a talent pool of over 150-200 personnel which will include about 45 doctors and 100-150 research associates, hospital authorities said in a statement.

The clinical research market in India is growing at an annual rate of approximately 100 percent and remains largely untapped with immense potential. The availability of a varied genetic pool, huge volume of patients and substantial capability makes clinical research in India very cost effective.

As per industry lobby FICCI & research firm Ernst & Young Survey report 2008, India may attract between 5-10 percent of the global contract research outsourced market over the next 5 years.
Utilising the size and strength of its network hospitals, Fortis will conduct all phases of clinical trials. Fortis will leverage the strength, the company said.

At least seven greenfield hospitals under this company are at the construction stages. It includes a state-of-the-art flagship facility at Gurgaon and the soon to be commissioned hospital at Shalimar Bagh in the national capital. Fortis currently has a network of 45 hospitals.

The countries ability to offer end-to-end services in clinical research covering trials, data management, biostatistics and central laboratory services makes it a preferred destination for trials and research.

A clinical trial conducted in India costs 50-60 per cent lower than that in the developed markets, the study said.

"As global pharma companies re-visit their strategies by dovetailing speed, cost of drug development and tapping high growth drug markets in their business models, India is emerging as the preferred choice for clinical research services," it said.

The number of companies engaged in drug development has risen the most in India among countries in Asia, Latin America and Eastern Europe.

The industry-sponsored, Phase-II,-III clinical trial study sites in India have grown by 116 per cent over the last 15 months with the country moving from rank 18 to 12 across the 60 most active countries.

India participates in 7 per cent of the global Phase III trials and 3.2 per cent in the Phase II trials with industry-sponsored trials, it said.

Faster patient recruitment and potential for cost savings are only a few of the factors attracting international sponsors to the emerging regions of clinical research. Countries like the Russian Federation, India and China offer similar attractions, as well as raising similar questions, when being considered as a location for clinical trials.

Similarities between these three countries include large patient pools enabling rapid recruitment due to massive treatment-naïve populations with diseases of both the developed and developing world. Russia, India and China are the next pace setters for pharmaceutical clinical trials, bringing both opportunities and challenges for the industry. The increasing inclusion of these markets in international trials indicates that leading Pharma and Biotech are recognising the advantages of conducting trials in these regions.

Aside from large patient populations, key benefits of these countries include: low cost of services, highly-competent labor pools and well equipped sites. However, local practices which differ from country to country, such as cultural, language, logistical, ethical and local regulatory requirements can make life challenging for companies performing clinical research. Specific issues faced by clinical trial operations across these three markets include protection of patients’ rights and safety, regulatorycompliance, inconsistent data quality, lack of sufficient numbers of trained clinical researchers and even site saturation.

This event will examine in detail the opportunities in these unique markets which present the fastest global growth in clinical trials for timely, high-quality and cost-effective clinical development. Experienced speakers will help you understand the differing cultural and other aspects which are essential for successful conduct of clinical trials, including establishing of strong business relationships and ensuring trials’ compliance with ICH GCP Guidelines.

NextLevel Pharma's "Emerging SUPERPOWERS in Clinical Research" event will also provide dedicated, 1 on 1 partnering sessions enabling sponsor companies (Pharma, Biotech, Vaccine, Diagnostic and Medical device manufacturers) to meet with CROs, Central Labs, leading consultants, software and other clinical solution providers experienced in these growing markets to discuss potential partnerships.

The proportion of global clinical trials conducted In India is expected to more than double between 2007 and 2012, according to market research firm RNCOS.

At the moment India only accounts for around 2 per cent of the total number of trials carried out around the world, with around 221 trials conducted in the country in 2007, according to RNCOS’ just-published report entitled Booming Clinical Trials Market in India.

This proportion is expected to reach 5 per cent by 2012, thanks to a huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings that could trim the cost of trials by 50 to 75 per cent.

The driver is offshoring of clinical research by the research-based drug industry, which is seeing a surge in the cost of drug development. RNCOS estimates the cost of developing a new drug at nearly US$1.2bn in 2008, with nearly half of the cost being spent on clinical trials (Phase I-IV).

As a result, nearly all major pharmaceutical/biotech companies and contract research organisations are establishing a presence in India, and the number of clinical trials in the country is expected to grow several fold in the next five years.

Companies can save a substantial amount in India on both staff and utilities, notes the report. For instance, the salary of a clinical research associate is only 13 per cent of that in the US and around 18 per cent of the equivalent in Western Europe. Similar mid-teen ratios apply when employing biostatisticians, it says, and companies can also save substantially on utilities and land while setting up their operations in India.

However, there are some potential brakes on growth, according to RNCOS.

“To achieve its goal of becoming a global hub of clinical trials, [India] has to overcome challenges like unethical trials, delays in trial approval, inappropriate protection of clinical data, and lack of Good Clinical Practice (GCP) certified sites and investigators,” it said.

The report identifies five key players in India’s clinical research arena, namely Syngene International, Quintiles Research (India), Lambda Therapeutic Research, Vimta Labs and Veeda Clinical Research.

Ahmedabad, Feb 20 (IANS) What Bangalore is to IT, Ahmedabad is to clinical research industry. Once known for its textiles industry, Ahmedabad is now fast becoming a hub for pharmaceutical companies, both from India and abroad, to set up clinical research organizations (CRO). “Right now Ahmedabad is at the top of the league of CROs in India. This status is only likely to strengthen further with more and more drug companies seeking to open CRO centres here because of cost effectiveness,” said V. Srivatsan, Director of Lambda Therapeutic Research Limited, a CRO sponsored by city-based Intas Pharmaceuticals Limited.

Clinical research is the effects of new drugs on humans for discovering the safety and efficiency levels of the drugs.

Besides Ahmedabad, the other major CRO centres in India are Mumbai, Chennai and Bangalore, Srivatsan added.

CRO business has also received a shot in the arm with the Institute of Clinical Research India (ICRI), spread over an area of 10,000 square feet, opening its campus here.

Srivatsan listed presence of a large and diverse patients’ pool for conducting clinical trials, excellent infrastructure facilities, availability of large pool of medical, pharmacy and science graduates and comparative cost advantage as the four reasons why Ahmedabad has emerged as a major hub for the industry.

The clinical research industry in the country, according to industry data, has grown five fold to Rs.1 billion in the last three years.

As per a recent McKinsey report, it is expected to touch Rs.50 billion ($12 billion) by 2010 and will employ 50,000 people.

According to industry estimates, the clinical trials market worldwide is worth over $45 billion and has the potential of generating large employment.

A rapidly growing health-care software company based in Cambridge is expanding its global presence in South Asia with the launch of a joint venture in Mumbai, India.

The company, Outcome Sciences Inc., has teamed with Los Angeles-based clinical-research firm RPM Alliance LLC to form RPM-Outcome, an operation that aims to break into the India market with Outcome's web-based system, which measures the quality of patient care at hospitals and physician practices, Outcome CEO Richard Gliklich said.

Outcome's joint venture in India comes after competitor Phase Forward Inc., a Waltham provider of clinical trials software, announced the opening of its subsidiary in the South Asian country late last year. Yet Phase Forward's subsidiary has set out to tap software engineers and quality-assurance workers there. Outcome's Gliklich said his firm's Indian venture would focus on gaining business there as the booming country's health-care system evolves with higher standards of care and more demand for Phase 4 trials.

"We want people on the ground to understand the needs and respond to the needs (in India)," said Gliklich, an otolaryngologist at Massachusetts Eye and Ear Infirmary in Boston, whose private company employs 125 people in Cambridge and 10 workers at its European office in Switzerland. The firm added 40 workers in Cambridge during 2007. The company declined to release a specific dollar amount of the India investment.

The joint venture is also intended to support existing and expanded use of Outcome's software for managing studies of drug and medical devices safety and effectiveness after the products are approved, or so-called Phase 4 clinical trials. The companies plan to announce the joint venture early next week.

A taste for India

India is already a well-trodden spot for clinical trials because of its vast number of patients and lower costs to perform such studies compared with the United States or Western Europe. But as India's expanding economy gives rise to a larger middle class, life sciences companies such as Cambridge biotech Genzyme Corp. have taken a greater interest in seeking drug and device approvals in India.

Genzyme is building a sales force in India to market Thymoglobulin, a drug to prevent the rejection of transplanted kidneys, spokeswoman Sarah Millerick said in an e-mail. The biotech has also used sites in the country for its clinical trials.

As a condition of regulatory approval, life sciences firms are often required to conduct Phase 4 clinical trials after medical products hit the market. And with more products gaining approval in India, Gliklich said, his company has had more demand for its Phase 4 software from its U.S. and European life sciences customers conducting post-market studies there.

Still, experts peg India's annual share of the multibillion-dollar market for clinical research at just $100 million. Ritvik Mehta, CEO of RPM Alliance, Outcome's partner in India, said in a statement that Phase 4 trials comprise 12 percent of India's clinical research market. However, Mehta said experts have projected the clinical research market in India as a whole would jump to $500 million or more by 2010.

In the RPM-Outcome joint venture, Outcome has agreed to contribute its technology while RPM -- which has its own subsidiary in Mumbai -- provides its knowledge of the Indian market and recruits staff for the combined operation, Gliklich said. One major goal for the venture is to penetrate the emerging market for products and services to measure quality of patient care in India, which lags Western countries in having quality-of-care standards in medicine.

The joint venture plans to work with the Quality Council of India, a national accreditation group, and an international affiliate of the Joint Commission, a U.S. hospital standards body, to tailor a web-based system Outcome and RPM have developed for reporting patient-care data in India. The Indian joint venture has started with five employees, executives said, and is likely to grow to 10 to 15 workers soon.

In the meantime, a number of health-care IT companies in the Boston area have modified products to serve the Indian market. PHT Corp. for instance, has put characters of several dialects spoken in India on the keys of its handheld electronic notebooks, which patients use to report data while in clinical trials, said Phil Lee, CEO of the Boston-based company.

Lee said that PHT, however, was unlikely to launch a subsidiary in India because it tries to put its offices close to its corporate customers in the United States and Europe, where it has an operation in Geneva. He added that Indic characters were added to PHT's devices because U.S. and European life sciences firms it serves had requested the changes for their clinical trials in India.

India is expected to host 30% of the world's contract research within the next 10-15 years, driven by the attractions of low cost and high quality standards, says the India Brand Equity Foundation, IBEF. The IBEF quotes a McKinsey forecast for the value of pharmaceutical clinical trial outsourcing in India at $1.23 billion by 2010. This would represent 7% of the total world market, projected by Biopharm at $18.5 billion in 2010.

India offers a huge cost advantage in clinical trials compared with Western countries. A multinational company moving R&D to India could save as much as 30-50%, IBEF says. Indian companies can conduct clinical trials at less than one-tenth of US costs.

The US National Institutes of Health trial registry (www.clinicaltrials.gov) lists 272 trials actively recruiting patients in the country, of which 60% are Phase III. There are currently 70 CROs in India, according to Biopharm’s Contract Research Annual Review 2006 - a number that is projected by to increase in the coming years.

Several western CROs, including Aptuit (US), Synergy Research Group (Russia) and ethica Clinical Research (Canada), have formed alliances or joint ventures with their Indian counterparts in recent months. Others, such as Parexel, have opened new offices in the country. Investment has also flowed in the opposite direction, with US CROs Radiant Research and Taractec both being acquired by Indian groups this year (Biopharm Development News passim).