Globalizing Clinical Trials to Include Emerging Markets

The conduct of clinical trials has increasingly become globalised and expanded well beyond the traditional regions of North America and Western Europe. Global trials now typically include centers based in Asia, Central and Eastern Europe, Central and South America and the Middle East. This globalization is the result of a number of significant advantages over limiting trials to traditional locations. These advantages include access to greater numbers of patients and hence faster recruitment, brand exposure to more markets, cost efficiencies and access to patient populations to facilitate marketing approvals in various countries.

However, this expansion also has resulted in a range of challenges both in terms of geographical scale as well as specific to working in emerging regions. The scale of these global trials raises challenges related to logistic issues such as IP supply and distribution, ancillary supplies, laboratory testing and sample shipping, management of services, management of communications, document management and collection of data. There also are unique challenges related to working in a diverse range of countries including: diverse clinical trial approval processes and regulatory requirements, import and export requirements, translation and language issues, access to experienced sites and clinical research staff.

The challenges can be overcome by ensuring that the correct infrastructure is in place to deal with global trials. Extensive global project management and planning systems and processes, electronic tracking systems and data management systems, global staff footprint, local regulatory expertise, localised clinical expertise and global vendor systems and partners are just some of the infrastructure required to successfully navigate global clinical trials. For companies without the infrastructure or not able to invest in implementing their own global infrastructure it is critical to carefully select the right development partner to help overcome these challenge.

This webinar will address in more detail the advantages of globalization as well as the best practices for overcoming the challenges.

Speakers

Garth Tierney, Executive Vice President, Asia/Pacific, INC Research

Garth Tierney is Executive Vice President, Asia/Pacific for INC Research. He oversees all operations for the Company in this critical region. He has nearly two decades of experience in Clinical Research Organizations including roles as Clinical Research Manager, General Manager, Managing Director and most recently Regional General Manager. During this time Mr. Tierney also was involved in management and direction of numerous projects across a broad spectrum of therapeutic areas. In addition to his CRO experience, Mr. Tierney also has six years of experience in clinical research in Pharmaceutical companies including roles as CRA, SCRA and Clinical Research Manager. Mr. Tierney established the South Australian operations for a global CRO which became the region’s biometric hub for the global CRO. He also established the first Singapore project for the same global CRO. Mr. Tierney was a founder, owner and Managing Director of Trident Clinical Research Pty Ltd, a company started in 1997 with operations in Australia, New Zealand and India. That company became the largest independent CRO in Australia and was acquired by INC Research in 2011.

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Silvia Zieher, MD, Vice President, Clinical Development and Latin America Operations, INC Research

Dr. Silvia Zieher is Vice President, Clinical Development and Latin America Operations at INC Research. She has nearly two decades of experience in clinical research in roles including Clinical Team Leader, Clinical Development Manager of a top ten Pharmaceutical company in Argentina and as CRO Clinical Research Director, Executive Director and Vice President of Clinical Development for Latin America. She joined the CRO industry in 2004. In addition to research experience, Dr Zieher worked in pediatrics in public and private institutions in Argentina. Her responsibilities have been focused on clinical operations activities in monitoring, project management as well as regulatory activities for the implementation of Phase II to III studies in Latin America. She contributed to training activities at regional and global levels, quality control activities and development of processes and SOPs. As Research Director and Senior Director she expanded company operations to Peru, Chile and Brazil and contributed to organic growth in Argentina and Mexico. As Clinical Development Manager, Dr. Zieher contributed to the development of the PAHO (Pan American Health Organization) guidelines: titled: “GCP: Document of the Americas” that were published in 2005, being the FIFARMA (Latin America Global Pharma industry) representative of the GCP expert working group at PANDRH (Pan American Network for Drug Regulatory Harmonization). This guideline is the foundation of many regulations in Latin America. She has conducted academic activities in clinical research and is a frequent presenter in international conferences as DIA.

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