Clinical Investigations in Asia

Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.

Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.

Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.

Clinical Investigations in Asia was presented by Edward C. Ian, Director of Operations in Asia, with PRA International and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

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From Emerging to Emerged: Clinical Development in Asia Pacific

Although in the past Asia Pacific was deemed an emerging region for clinical research, it has now evolved and emerged, catching the interest of global pharmaceutical and biotech companies. Good Clinical Practice (GCP) was adopted as a local regulatory requirement in most of these counties in the late 1990s. Since then, industry-funded clinical research has grown rapidly in the eleven countries that are routinely considered for global IND studies.

The reasons for this growth are simple: Asia Pacific provides sponsors with several advantages, including streamlined regulatory and IRB processes, highly educated investigators and study personnel, well-equipped qualified study institutions, strengthened clinical research infrastructure, and internationally recognized standard treatments.

This presentation reviews the major factors that have made Asia Pacific such an attractive region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing clinical trials in the Asia Pacific region. Attendees also receive practical advice on critical points to take into account when conducting trials in Asia Pacific.

From Emerging to Emerged: Clinical Development in Asia Pacific is being presented by Edward C. Ian, Senior Director of Clinical Operations, Asia Pacific, with PRA International and airs on Wednesday, September 2, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

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