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IndiPharm has appointed a new director of operations to provide comprehensive clinical research project control in India.
IndiPharm Appoints New Director of Operations: Providing Comprehensive Clinical Research Project Control in India
Radnor, PA, USA, and Mumbai, India – December 4, 2008-IndiPharm has appointed Nigel McBean, as VP and Director of Operations at its operational headquarters in Mumbai, India. In this new position, McBean will be responsible for all operational activities of IndiPharm (India) Pvt. Ltd., the wholly owned subsidiary of IndiPharm. These activities include identification and recruitment of investigators and clinical research sites, regulatory approvals, project and site management, monitoring, and pharmacovigilance. He will be based at IndiPharm’s Indian headquarters offices in Mumbai, and will be responsible for expanding and managing the India based staff of the company.
McBean has extensive knowledge in managing clinical research projects in Asia and the Pacific, ranging in size from 20 patient single-center studies to 5000 plus patient multi-country studies. He has managed global clinical projects in North and South America, Africa, the Middle East and Europe across multiple therapeutic areas including infectious diseases, oncology, cardiovascular, dermatology, urology and immunology.
He has lived and worked extensively in the Asia and Pacific regions, has an excellent understanding of the operational and cultural hurdles, and experience overcoming them to complete successful clinical research projects.
James A. Bannon, IndiPharm’s Chairman of the Board said, “Western clients will benefit from Nigel’s global clinical trial management experience and his direct leadership of our Indian operations in meeting the project timelines, quality standards and regulatory expectations.” The foundation of the Indian operations is the Indian Investigator Network (IIN) which will be managed by McBean. The IIN is a network of highly experienced clinical investigators who have extensive experience in multinational clinical trials in a wide range of therapeutic areas. Members of the IIN are in the major cities in India, are all ICH/GCP (International Conference of Harmonization and Good Clinical Practices) compliant, and include leading academic as well as private research centers that have established Independent Review Boards.
McBean was formerly the Director of Multi-Centre Research for PRACS Institute Ltd. (now part of the Cetero Research Group), where he implemented an electronic clinical management system to support management of client’s projects from inception to final clinical report. He also developed a clinical database which evaluates potential sites based on investigator details and experience, the facilities and staff, local regulatory turnaround time, recruitment performance, patient demographics, and site availability. His other areas of responsibility included sales, revenue generation, and overall management of the business unit reporting to the CEO.
Prior to his time at PRACS, McBean was Associate Director of Clinical Operations, Vaccines for MedImmune, Inc. in Gaithersburg, Maryland. From 1991 to 2004 he held positions at GlaxoSmithKline and SmithKlineBeecham that began in product formulation, moved to clinical development and concluded with senior positions overseeing R&D in clinical development across cardiovascular, urology, anti-infectives, anti-virals and tropical diseases.
IndiPharm is a U.S. based clinical research organization providing western pharmaceutical and biotechnology companies a full range of clinical trial services through its network of qualified physicians and scientists located in India, enabling those companies to conduct registration quality clinical trials quicker and at a lower cost than in the United States and other Western countries. Contact Rob Hughes, Vice President of Sales and Marketing at info@IndiPharm.com