Singapore: Today there is true growth potential in the Asian clinical trials market. Read any market report and this is obvious. With this growth there are ever expanding opportunities for eClinical technologies as their use is embraced by local and global biopharmaceutical companies in the region. While systems such as Electronic Data Capture (EDC) have been established for some time, other systems like Randomization and Trial Supply Management (RTSM) - also known as IRT (Interactive Response Technology) - are now beginning to see increasing adoption in markets such as China, Japan, South Korea and Taiwan, China.
RTSM involves the activities associated with real-time processing and monitoring of enrolment, treatment allocation, dosing, dispensing and clinical supplies tracking. The RTSM market size in Asia-Pacific (APAC) is expected to reach US$46.4 million by 2018 (a CAGR of 19.1 percent, compared with a worldwide estimated CAGR of 13.2 percent between 2013-2018).
To succeed in these markets and drive their adoption of RTSM, it is essential to not only rely on strategies that have worked in other markets but to also adapt to the unique needs of Asian markets. It's important to understand that building sustainable RTSM services in Asia cannot be achieved overnight and can be challenging to execute effectively in markets that are rapidly evolving and changing. Some of the unique challenges in applying the benefits of RTSM in these countries, include providing the following:
1. Local project services and support teams with domain expertise
2. User interface and end user documentation in local language
3. Service, system and process capabilities adapted for local markets
4. APAC market knowledge and applying global expertise where necessary
5. Cost-effective implementation, maintenance and operations
Local Project Services and Support Teams with Domain Expertise
It is often said the best way to learn about a region or country is to visit, to meet the people and to have in-person meetings. When it comes to providing RTSM services in Asia, the best approach is to utilize in-region project services and support teams that are subject matter experts. Developing and maintaining expertise in the region is critical to ensure success. However, there is a very limited pool of in-region resource with RTSM domain expertise and therefore one must invest in a long-term plan to build operations and achieve a knowledgeable critical mass. Resources need to understand patient transactions, unblinding to treatment and medication management functionality due to the criticality of ensuring each patient is randomized to the correct treatment and receives the correct drug (and dose) at every visit.
User Interface and End User Documentation in Local Language
Imagine trying to enter data or read end user documentation in a foreign language. When sites are trying to randomize and dispense medication in real-time without keeping patients waiting, they require an RTSM system and supporting documentation that can help them to achieve this easily and quickly.
For a site enrolling and dispensing medication to patients on a clinical trial in Asia, it is essential to have both an interface localized to the local market needs and user documentation describing the different RTSM system transactions in the local language - as not every end-user speaks, reads and writes English. While this may seem relatively straightforward, it can be very challenging and lead to confusion at sites, unless those translating the user interface and end user documentation into the local language understand the industry specific terminology associated with clinical trials. Direct translations from English to Mandarin or Japanese and Korean do not always work in the context of clinical trial terminology. For example, something as simple as 'Monitor' when referring to a Clinical Research Associate could be translated to a 'monitor screen' or something similar, which obviously has nothing to do with a CRA.
Service, System and Process Capabilities Adapted for Local Markets
One of the key advances achieved in the evolution of RTSM services in the last five years has been the move to more standardized development approaches . This ha...
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