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.

The Continuing Evolution of Clinical Research in India

is being presented by Dr. Vijai Kumar & Dan McDonald, President/Chief Medical Officer & Vice President Business Strategy, with Excel Life Sciences and airs on Tuesday, April 5th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The continued growth of clinical research in India can be attributed to a number of factors. The regulatory environment has improved in recent years, as has the infrastructure and the level of experience. These, when combined with the never-ending quest to reduce drug development costs and timelines, have fueled an increase in the number of clinical trials in India. With that expansion has come a growing diversity in both the size and types of trials sponsors are seeking to conduct in the Indian market. In response to this diversification, the regulatory requirements continue to evolve, both in an official context and also through the views and opinions of the agency and how they are evaluating the submissions.

Though the market for clinical trials in India has improved dramatically, a number of complexities still exist and like most markets today, specifics in the regulatory guidelines, combined with regional and cultural intricacies make having an strong grasp on these elements critical. This audio conference presentation is designed to provide attendees with specific details regarding the regulatory guidelines that exist today in India, and where these regulations might be headed in the future.

Logistical Considerations for Clinical Trials in India

is being presented by Anthony Leone & Stevie Hills, International Customer Service Manager & International Customer Service Supervisor, with World Courier, Inc. and airs on Tuesday, July 27th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

India is one of the primary emerging markets for the pharmaceutical and biotechnology industries. Clinical trial expenditure in India for 2010 is expected to reach one billion dollars. This projection greatly exceeds 2009 spend. While India offers many compelling reasons to attract focus in the emerging market arena it also presents logistical challenges.

This presentation focuses on how you can ensure regulatory compliance and supply chain integrity at any stage of the clinical study pipeline when conducting studies in India. Our speakers reveal what advance planning and effective partnerships with logistical providers can mean to the success of your projects. The presentation draws on real-life anecdotes to provide transportation advice and reinforce the necessity of doing your homework in order to successfully conduct clinical studies in India.

Clinical Trials: Why is India Irresistible?

In recent years, India has proven itself as a solid-performing region for conducting clinical trials. As it has evolved and emerged, it has caught the attention of global pharmaceutical and biotech companies. The reason for the growth in this region is simple: India, with a population of over 1.15 billion people, has one of the largest patient populations in the world. In addition to its large patient population, India has nearly 700,000 specialty hospital beds, 290-plus medical colleges, and skilled English-speaking medical professionals.

In this session we examine the factors that have made India one of the hottest places in the world to conduct clinical trials. Attendees come away with proven strategies to overcome challenges and maximize the “India advantage.”

Clinical Trials: Why is India Irresistible? is being presented by Dr. Pramod Kabra, Director of Clinical Operations, with PRA International and airs on Thursday, January 28, 2010. For more details or to register, please visit our site at www.fxconferences.com

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

Determining Feasibility in Global Clinical Trials

The single greatest challenge to drug development today is successful patient accrual. The sheer volume of actively recruiting trials advertised by the NIH -- nearly 16,000 in 2006 -- illustrates the extensive competition for patients to participate in clinical trials in the United States. In an effort to access more patient populations to address these issues, it has become necessary to include a global mix of countries.

The key to including sites outside the United States is understanding exactly where the selected patient populations are located. Detailed feasibility is a critical step to planning and conducting successful global clinical trials. Understanding the medical standards of care, local healthcare systems, national health insurance and reimbursement, drug importation and tax implications, local regulatory requirements and treatment paradigms are all essential to determining where globally to place a specific clinical trial.

This presentation focuses on how to perform global feasibility to aid in the planning and conduct of clinical trials to economize your development times and clinical trial costs and explores the benefits of including regions such as Eastern Europe, Latin America, Asia and India.

Determining Feasibility in Global Clinical Trials was presented by Kent Thoelke, Sr. Vice President, with PRA International and aired on 2007-08-02. This conference is available for download at www.fxconferences.com

Leveraging Technology for Conducting More Efficient Trials in India

Compelling fundamentals are driving the growth factor of the clinical development sector in India. There is potential for innovation and sector transformation if technologies, processes and workflow can be leveraged to select quality sites that have the subject populations to meet enrollment goals and efficiently manage your clinical trial projects while enhancing the quality, regulatory and ethics training of clinical site research personnel. Are your clinical trial management processes well-suited for this clinical trials landscape? Increasing efficiency with costing and timelines is crucial to a successful trial, and there are an array of technologies available to help you achieve your clinical trial goals.

This audio conference will provide insights on technology, process and procedures to effectively manage clinical trials in India. You will be armed with the most efficient technology-based solutions mapped with workflow processes for continued success in the Indian pharmaceutical marketplace.

Leveraging Technology for Conducting More Efficient Trials in India is being presented on Wednesday, March 18th, 2009. For more details, please visit our site www.fxconferences.com

Determining Feasibility in Global Clinical Trials

The single greatest challenge to drug development today is successful patient accrual. The sheer volume of actively recruiting trials advertised by the NIH -- nearly 16,000 in 2006 -- illustrates the extensive competition for patients to participate in clinical trials in the United States. In an effort to access more patient populations to address these issues, it has become necessary to include a global mix of countries.

The key to including sites outside the United States is understanding exactly where the selected patient populations are located. Detailed feasibility is a critical step to planning and conducting successful global clinical trials. Understanding the medical standards of care, local healthcare systems, national health insurance and reimbursement, drug importation and tax implications, local regulatory requirements and treatment paradigms are all essential to determining where globally to place a specific clinical trial.

This presentation focuses on how to perform global feasibility to aid in the planning and conduct of clinical trials to economize your development times and clinical trial costs and explores the benefits of including regions such as Eastern Europe, Latin America, Asia and India.

Determining Feasibility in Global Clinical Trials aired on 2007-08-02 and was presented by Kent Thoelke, Sr. Vice President, with PRA International. For more details please visit our site www.fxconferences.com

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

This audio conference is presented by Nermeen Varawalla of PRA International. To learn more, please visit www.fxconferences.com.