Clinical Trial Success in Latin America

Latin America has proved to be a solidly performing region for clinical trials, catching the interest of global pharmaceutical and biotech companies. GCP (Good Clinical Practice) has been adopted as local regulatory requirement in most Latin American countries over the last decade. Since then, industry-funded clinical research has grown rapidly, and Latin America is routinely considered for global drug development programs. The reasons for this growth are simple: a large patient population, solid investigators with experience in clinical research, well-equipped qualified study institutions, strengthened clinical research infrastructure (laboratories, drug depot services and logistics), and internationally recognized standard treatments.

This audio conference reviews the major factors that have made Latin America a successful region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing Latin American clinical trials, while sharing practical advice on critical points to take into account when conducting trials in Latin America.

Clinical Trial Success in Latin America is being presented by Dr. Frederico Lerner, Senior Director of Operations, with PRA International and airs on Friday, November 13, 2009. For more details or to register, 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

Untapped Clinical Development Opportunity in Latin America

Latin America is among the top emerging regions in the world for clinical research, and provides expanding opportunities for biopharmaceutical product development. The region offers rapid access to patients, lower costs of conducting clinical studies, and availability of highly trained professionals for clinical development. Latin America also offers attractive end markets for biopharmaceutical products.

Currently, more than 80% of the regional market share of pharmaceutical sales and growth is distributed among Argentina, Brazil, and Mexico. However, leading biopharmaceutical companies are starting to uncover new opportunities in other Latin American countries, including Costa Rica, the Dominican Republic, Ecuador, Guatemala, Panama, and Venezuela, that have not been traditionally tapped for clinical development. The speakers will review how to unlock this potential through proper planning and a risk-managed approach.

Drawing on extensive expertise, first-hand knowledge, and experience, these experts discuss how biopharmaceutical companies can achieve clinical trial success for both in-country and international marketing approvals. The speakers discuss the pros and cons of conducting clinical research in "non-traditional" Latin American countries, and provide key risk-based approaches.

Untapped Clinical Development Opportunity in Latin America was presented by Dr. Alberto Grignolo, Diego Glancszpigel & Graciela Racaro, Vice President, General Manager, Vice President, Latin America Operations, Senior Director, Latin America Operations, with PAREXEL. This conference aired on 2008-06-05 and is available for download 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 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

Alternative Sites for Clinical Trials: Latin America

This is the third in a series of audio conferences featuring speakers from Covance discussing the benefits and pitfalls of using non-traditional sites for clinical research.

Conducting business in Latin America has proven beneficial to pharmaceutical companies by providing expanded patient access, including medically naive patients. This region also provides access to unique clinical indications. Business in the region continues to grow in spite of the many challenges that still exist and the regulations that continue to impact access to specimens in the different countries. In this audio conference, Conchita Delgado addresses these challenges and present solutions to overcome them.

Alternative Sites for Clinical Trials: Latin America is presented by Conchita Delgado, Manager, Latin America, of Covance Central Laboratories. For more details on this audio conference, please visit our web site www.fxconferences.com