Where strong relationships count
The Chinese market for clinical trials is growing at an enormous pace. Joanne Payne and Jonathan Hare discover what it is like to work in the country.
China is the world’s second-largest economy and has a pharmaceutical industry that has grown by approximately 22% annually over the past five years. Industry analysts predict that in 2010, the total value of the global pharmaceutical market will grow by 4-6%, to more than $825 billion. China, at 21% growth, tops the list of the fastest-growing markets; the US sector is expected to expand by just 3-5%.
A little more than a decade ago, while there had been some preclinical studies undertaken, Chinese soil had never hosted a significant clinical trial. The market really began to take off in the years following China’s admission to the World Trade Organization (WTO) in 2001, which committed it to meeting international standards. In the following years, China’s economic miracle and burgeoning middle class made the country increasingly significant as a market for drug companies.
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Reviving Japan's clinical trial system
In one year the number of clinical trials carried out in Japan rose from 56 to 96. Norio Tamura explains what steps the Japanese government has taken to make the country's clinical trial environment more familiar to international sponsors.
Japan is one of a few countries that develop innovative medicines for patients globally and, as in other countries, such as the US and China, Japan has some unique regulatory requirements for conducting its clinical trials. In 1996 the ICH-GCP standards were agreed across Japan, the US and the EU, meaning there is almost no difference in implementing R&D in those regions from a regulatory perspective.
But in 1997, new J-GCP legislation was adopted in accordance with ICH-GCP and this dramatically changed the drug development landscape in Japan. It caused scientific and ethical standards to improve, as well as improved data reliability, making it more appealing for pharmaceutical organisations to conduct studies in the country.
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CROs find a Seoul mate in South Korea
As a location for global clinical research, South Korea resembles many countries in more traditional geographies, with its modern infrastructure and well educated English-speaking staff. Small wonder its costs are not far off those in the west, explains Faraz Kermani.
As the global market for clinical trials becomes more competitive and the demand increases for more diverse ethnic populations for these studies, CROs are prepared to spread their nets wider than ever before. Country selection, however, is by no means simple, particularly where the global acceptability of results is a key consideration. With this in mind, a serious case can be made for South Korea as a reliable and rewarding place in which to undertake clinical trials.
Companies wishing to conduct clinical research in South Korea must bear in mind that some 40% of the country’s population lives in and around the capital city of Seoul. Most major hospitals are in this region, and are reachable within an hour from almost all of the country. As South Korea is relatively small, it is possible to complete a monitoring process in any region and return home on the same day. The travelling time naturally also applies to patients recruited for trials. This geographical proximity and the size of trial sites make the Korean clinical trial extremely cost-effective.
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Taiwanese studies on the up too
The number of CROs looking to operate and undertake clinical trials in Taiwan is on the increase and this is hardly surprising. The quality of trials is equivalent to those carried out in more established nations in this field, including those of Western Europe, the US and Japan.
Furthermore, Taiwan adheres closely to ICH-GCP guidelines, which were introduced by the Department of Health (DoH) in 1997 and revised in 2002. The pitfall for CROs is that, as befits a well-educated population, it appears that patients undergoing clinical trials in Taiwan are not as naive as in other countries in which such studies are more at a development stage.
Sites are often inspected by the DoH to ensure that they are of the highest standard. The results of such inspections are graded as: accepted; accepted upon further clarification; re-inspection required; case dismissed; or pending supplement from trial companies (sponsors).
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Clearly differentiated
Clearstone has been a provider of central laboratory services to the pharma industry for more than two decades. Now the company is leveraging its first-mover position in China to tap Asia-Pacific emerging markets.
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| Lewis Cameron |
Q. When and how was Clearstone Central Laboratories founded?
Clearstone the brand was founded in 2009. However, as a central laboratory, we have been around since 1988, operating under the name of MDS.
Today, Clearstone is the largest privately-owned independent central lab with a global footprint in the Americas, Europe and Asia-Pacific. With more than 20 years' experience in mature and emerging markets, Clearstone offers world-class safety and esoteric testing capabilities, project and data management services, and logistical support to many of the leading pharmaceutical and biotech companies around the world.
We have more than 500 employees worldwide at our wholly-owned CAP-certified and state-of-the-art laboratories in Beijing, Hamburg, Paris, Singapore and Toronto. We also own and operate a leading-edge central laboratory protocol management system, APOLLO CLPM™.
Clearstone has an extensive history in the drug development industry, having worked on more than 3,000 clinical trials. We are especially proud of our global footprint and capabilities with nearly 80% of our more than 500 active trials being of a global nature.
Since the Clearstone brand was created last year, we have made a number of adjustments to our management structure to strengthen our operational performance. In line with our business strategy, we have enhanced our quality assurance capabilities to ensure continued process improvement and focused our global management team on providing world-class delivery of service to meet our clients' needs.
Q. What differentiates Clearstone from other central labs?
There are many areas where we believe Clearstone is differentiated from other central labs, including:
Global network: Firstly, we can offer a truly integrated global service with the added value of our local expertise and deep understanding of regional and cultural differences. This allows us to use fully harmonised processes and capabilities, while at the same time managing regional and country-specific requirements.
APOLLO CLPM™: Clearstone also provides clients with a unique and state-of-the-art CTMS IT platform. This is a truly global and integrated platform with real-time access from all our operations. APOLLO not only allows for faster and more accurate reporting capabilities, but also provides our clients with real-time access to data. This is a major advantage in an environment where immediate access to safety data and results is critical. APOLLO removes barriers for our clients and allows them to instantly access their reports anytime, anywhere – without added communication requests.
Asia-Pacific: Another key differentiator is our coverage of emerging markets and the Asia-Pacific region more specifically with CAP-certified laboratories in both China and Singapore. In fact, Clearstone was the first dedicated and CAP-accredited central lab in China obtaining NGSP Level I status nearly 15 years ago and continues to be a market leader in this region today. We have had the pleasure of working with an impressive list of clients conducting clinical research in China with more than 30,000 patients, and continue to make significant investments to advance our leadership position in the region. In fact, we recently moved to a new state-of-the-art facility in Beijing with five-times the capacity and expanded our test menu with an extensive pharmacogenomics offering – creating a new global centre of excellence within Clearstone for specific testing and biomarker development.
Flexibility: We also pride ourselves on being flexible to meet clients' needs. Clearstone’s Project Management group works closely with the functional operational teams to ensure all our clinical trials have been set up to meet the specific requirements of each study. This is further facilitated by the Apollo CTMS system which can be programmed to meet specific management and reporting criteria.
Q. What challenges do you face?
With a growing number of drug labels containing pharmacogenomic information, we believe that offering a comprehensive pharmacogenomic test menu represents both a challenge and an opportunity for Clearstone. This is why we deployed the Affymetrix DMET system in a recent expansion of our China laboratory. The DMET platform is the most comprehensive and cost-effective panel of pharmacogenomic markers to simultaneously survey hundreds of drug metabolising enzyme and transporter genes through a standardised approach that enables faster discovery and measurement of genetic variation associated with drug response. This investment reflects Clearstone’s continued commitment to bring in-house specialty assays to assist our clients in protecting patient safety and bringing life-saving medications to market faster.
We must also maintain a highly efficient and effective cost structure to succeed in a competitive global market. This, of course, includes our own laboratory services and operations, but also extends to other areas such as study logistics. These costs can make up a significant portion of the overall budget for our clients, and therefore we need to work more closely with third parties such as couriers. An example of this is our recent collaboration with TNT couriers. TNT clearly understands our clients' requirements and business drivers, and has begun working more closely with us to streamline its operations and open more efficient traffic lanes for the thousands of biological samples and kit supplies that we ship every day.
Q. How has Clearstone addressed the changing needs of the clinical research industry?
The pharmaceutical industry faces increased pressure on drug development timelines and cost effectiveness, but the globalisation of clinical trials has also made the regulatory environment much more complex. The continuing shift of drug development activity to emerging markets means that we must maintain and grow our knowledge base and capabilities in these regions. Clearstone’s broad experience in Asia puts us in a strong position to match this dynamic shift, and our fully-owned APOLLO system provides a robust architecture to support our global footprint and clinical applications today and in the future.
The needs of the central laboratory industry are driven by some of the challenges discussed above. But overall, central labs need to shift from what is perceived as a commodity service to provide more engaged relationships with their clients. This will involve working closely with others in the critical path of clinical trials, with increased awareness of the regulatory and scientific environment. Clearstone is focused on increasing awareness around communication in project management between central labs and CROs or pharma companies. Also, the rapidly advancing electronic data environment means our data management group must be at the forefront of data integration for laboratory data.
Q. What are your plans for growth?
We will continue to invest in our scientific capabilities and core service offering to improve and streamline processes, and ensure service excellence and growth in the years ahead. Clearstone has made significant enhancements to its operations and global footprint, and may pursue additional opportunities in India and Latin America to accelerate growth in these regions as well.
We also believe we can maintain our leadership position in Asia and other key markets by staying abreast of the latest regulatory advances, and continuing to invest in our people, scientific capabilities, strategic relationships and state-of-the-art facilities and systems. Above all, we must continue to meet and exceed our clients’ expectations each and every day with the high level of service and responsiveness we have become known for in the industry.
At a glance:
• Founded in 1988 with 500 employees worldwide
• Five wholly-owned and CAP-certified labs in Beijing, Hamburg, Paris, Singapore and Toronto
• Extensive history with more than 3,000 clinical trials in all therapeutic areas
• First dedicated and CAP-accredited central lab in China obtaining NGSP Level I nearly 15 years ago
• Impressive list of clients conducting clinical research in China with more than 30,000 patients
• Recent investment in state-of-the-art Beijing facility with five-times the capacity and expanded our test menu with an extensive pharmacogenomics offering – creating a new global centre of excellence for specific testing and biomarker development
Lewis Cameron, CEO of Clearstone
