home > ict > spring 2006 > pacific overtures
International Clinical Trials

Pacific Overtures

Graham Bunn at Medidata Solutions Worldwide explores experiences of electronic data capture implementation in Asia Pacific

The Asia Pacific region is becoming increasingly important for biopharmaceutical companies. The emerging markets are demonstrating an increasing need for high quality healthcare, while providing an attractive environment to conduct first-rate clinical trials with rapid access to treatment-naïve patients, excellent investigators and low R&D costs. This shift in the global clinical trial landscape is occurring as the industry rapidly moves from traditional paper-based data management techniques towards more advanced electronic data capture (EDC) and electronic data management (EDM) techniques. This article examines some of the considerations required when conducting EDC/EDM-based trials in the Asia Pacific region, along with the advantages EDC/EDM can bring to these large, remote trials that are often difficult to manage.

The clinical trials market in Asia is continuing to see major, perhaps unprecedented, growth as the balance of the pharmaceutical market continues to swing away from the US and Europe towards the world’s fast developing economies. These are typically defined by a per capita gross national income (GNI) of less than US$20,000 and embody much of the Asia Pacific region. In emerging markets, the availability of healthcare is rapidly expanding, and with it there is an increasing need for treatments for chronic diseases typically associated with developed countries.

The emerging markets currently represent just 17 per cent of the global pharmaceutical market, but in 2007 it is predicted they will contribute 30 per cent of the growth (1). The rising demand for high quality healthcare and the fast growing pharmaceutical market can mean that clinical trials either located fully within the Asia Pacific region, or global trials with sites located within Asia Pacific, are also rapidly on the increase and changing the global clinical trial landscape.

When these business drivers are added to the advantages of conducting clinical trials in Asia Pacific, it’s easy to see why such rapid growth in clinical trials is taking place within this region. Investigators in these areas are frequently more open to new technologies, have fast access to treatment-naïve patients from a culturally diverse population, and because trials in Asia Pacific have reduced R&D costs yet frequently manage accelerated R&D timelines, it’s a win-win situation.

While this change in global trials is taking place, biopharmaceutical companies are rapidly changing the technology used to collect and process clinical data in their drive towards more efficient trials. Paper is being rapidly phased out and EDC is on the way in. As of 2006, an estimated 20 per cent of all study starts now use EDC, and this trend continues to grow at a compound annual growth rate (CAGR) of approximately 30-40 per cent by the end of 2007 (see Figure 1). This is bringing together clinical trials involving both new technology and the Asia Pacific region at an ever increasing rate, so it is important to understand the differences associated with running EDC trials in this region.

Asia Pacific is typically defined in terms of clinical trials space, including countries such as India, Pakistan, China, Indonesia, Singapore, Thailand, Philippines, Taiwan, Japan, Australia and New Zealand amongst others. Indeed, not all of these can be considered as emerging markets, but many of the potential EDC differences are common to all locations.


There are certainly many differences between running clinical trials in Asia Pacific and the Western world, but many of these (such as those associated with regulatory approval, for example) apply equally to both paper and EDC. This article focuses on major differences that arise when running clinical trials in Asia Pacific where EDC can make a positive impact and improve the situation across the paper world, or where additional attention is required to make sure EDC trials progress normally. Given this mandate, the four most significant differences regarding the conduct of EDC clinical trials in Asia Pacific (in comparison to the US, Canada and Western Europe) can be summed up as language, distance, infrastructure and culture.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

As Vice President of Global CRO Partnerships at Medidata Solutions, Dr Graham Bunn coordinates and manages relationships with various CRO partners. An early pioneer of EDC technologies, prior to joining Medidata Solutions Graham held a variety of executive and senior level positions at Quintiles, including Global VP of eClinical Business Development. He has also acted as Global VP of Business IT at Clinsoft Ltd (Domain Pharma) and has worked in pre-sales at BBN Software Products. Graham is currently a member of the Electronic Data Management Forum and the DIA, and is actively involved in the European CDISC Coordinating Committee (E3C). He has chaired and presented at many industry seminars on EDC, eClinical and IT, and has written articles for pharmaceutical industry publications on successful eClinical implementation.
Dr Graham Bunn
Print this page
Send to a friend
Privacy statement
News and Press Releases

Destiny Pharma appoints MedPharm to develop new XF-platform drug formulations

Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, is pleased to announce that it has appointed MedPharm as its expert partner to develop new topical formulations of the Company’s novel XF-platform compounds. These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti-microbial resistance (AMR). MedPharm is a world leading contract provider of topical and transdermal product design and formulation development services using sophisticated in vitro models to de-risk development programmes.
More info >>

White Papers

A Rules Based Approach to Labelling and Artwork Management


Many organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative. Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) also require that labelling content to be published electronically in addition to print. As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling.
More info >>

Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement