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European Pharmaceutical Contractor

Establishing Operational Sites in India

With ever-increasing pressures on the pharmaceutical industry to improve productivity and reduce costs, it is small wonder that Western-based pharmaceutical companies and contract research organisations (CROs) are looking further afield to conduct clinical trials and related support activities. India is responding well to this opportunity and the potential benefits to all are evident. However, a clear, long-term business strategy is essential. As pharmaceutical companies race to get new drugs to market, pressures on finite patient populations and spiralling developmental costs are making the industry look beyond traditional centres of clinical research to Eastern Europe, Latin America and Asia.

The last decade has seen slow but steady growth in clinical research being conducted in India and, just as it responded to other Western-based industries, the country is rising to the challenge. Hospitals have developed well-equipped research facilities, increasing numbers of ICH/GCP-trained investigators are available and the Indian Government is set to establish a regulatory framework compatible with global standards, with a number of key initiatives already in place.

In addition, the local pharmaceutical industry is experiencing considerable growth, constituting approximately 1.3 per cent of the world market in value and eight per cent in volume in 2002 (1). As a result of modern, robust technology infrastructures, information processing and exchange is now a global activity, making the international transfer of data and business activities routine. India already has a growing reputation in the field of business process outsourcing and its rapidly developing IT market has grown from approximately billion to more than billion in less than a decade. Over 200 of the Fortune 500 companies outsource software development to India (2) and the UK National Health Service (NHS) has recently awarded an IT contract worth more than ?100 million to two Indian firms (3).


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By Subash Sadanandan and Tina Young, Company Directors of InDatum Ltd, UK, and InDatum Research Data Services, India

Subash Sadanandan has over 17 years' experience of evaluating, validating and implementing technical systems and infrastructures within the clinical research environment. He is a co-founding Director of InDatum, a CRO specialising in the provision of biometric services. Subash has personal experience of working in India and in recent years has conducted a thorough evaluation of technical facilities in the region.

Tina Young has 20 years' experience within the pharmaceutical industry, specialising in the field of clinical trial data management and analysis, and the establishment and management of new, remote operational facilities. She is a co-founding Director of InDatum.



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Subash Sadanandan
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Tina Young
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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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News and Press Releases

Azopharma Product Development Group, Inc

HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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