Best Practices for Conducting Clinical Trials in Emerging Countries

is being presented by Dr. Nermeen Varawalla, CEO, of ECCRO and airs on Tuesday, April 17th, 2012. For more details or to register, please visit our site at www.fxconferences.com

The value of emerging countries in delivering cost-effective patient recruitment is well documented. However concerns remain about data quality, GCP compliance, extrapolation of trial outcomes and regulatory hurdles. These concerns often can be addressed by combining an understanding of international clinical trial requirements and local expertise.

Our speaker for this event is Dr. Nermeen Varawalla, a reknowned expert on the conduct of clinical studies in emerging markets in general, and India in particular. In this presentation she discusses how to take things one step further by customizing industry best practices for the emerging clinical trial environment. These include the formation of select investigator networks, integrated site management and data-driven, hybrid monitoring. In this presentation, Dr. Varawalla shares case studies highlighting her work in India to illustrate the effectiveness of these practices in overcoming typical concerns about conducting clinical research in emerging countries.

Leveraging Clinical Development Opportunities in India

India presents a compelling environment for global clinical trials because of its access to investigators, large patient populations with diseases of the industrialized and developing world, a cost-effective, English-speaking graduate workforce, and progressive regulatory environment. These benefits are now well recognized by the global pharmaceutical industry. Moreover, because of India's pristine FDA audits, continued streamlining of regulatory approvals and demonstrated intent to uphold international intellectual property standards, the country has become even more attractive as an important locale for clinical development.

As a result, multinational pharmaceutical companies are striving to build clinical development capabilities within their local operating companies in India, and the country's nascent CRO industry is enjoying an annual growth of about 40%. This, however, poses resourcing constraints and unresolved ethical issues about the robustness of patient consent. Hence, it is becoming increasingly important for sponsors to select investigators, sites and resources that will be able to deliver data of the quality and integrity that they seek.

This presentation draws on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.

Leveraging Clinical Development Opportunities in India was presented by Dr. Nermeen Varawalla, Vice President, Investigator Relations, with PRA International and aired on 2007-05-30. For more details or to download this event, please visit our site at www.fxconferences.com