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Clearly Differentiated

Clearstone has been a provider of central laboratory services to pharma for more than two decades. Recently acquired by LabCorp, the company continues to leverage its first-mover position in China to tap Asia-Pacific growth opportunities.

Jenny Zhang Vice-President of Global Laboratory Operations & General Manager, Asia

Q. What services does Clearstone Central Laboratories provide to the pharmaceutical market?

Clearstone, the brand, was founded in 2009. However, as a central laboratory we have been around since 1988. Today, Clearstone is a leading provider of central laboratory services for late-stage clinical trials with a global footprint in the Americas, Europe and the Asia-Pacific region. We have an extensive history in the drug development industry, having worked on more than 3,000 clinical trials across every major therapeutic area, and are especially proud of our global capabilities, with nearly 80% of our active trials being of a global nature. With more than 20 years’ experience in both 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.

Q. What does the acquisition by LabCorp mean for your clients?

The combination creates new growth opportunities for both companies and long-term strategic value for our clients. Under a strategic collaboration agreement, Clearstone has already been working closely with LabCorp’s Esoterix Clinical Trials Services division for the past year. This has resulted in a number of client success stories. Now that LabCorp has fully acquired Clearstone, we will be a single team with complementary strengths, completely focused on exceeding our customers’ drug development objectives.

The combined organisation has a comprehensive specialty/ biomarker, bioanalytical and safety testing portfolio, and we can offer our clients a broad test menu with over 4,000 validated assays.

Q. What differentiates Clearstone from other central labs?

Our unique selling points include:
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.
Asia-Pacific: Another key differentiator is our coverage of emerging markets – and the Asia-Pacific region more specifically – with CAPcertified laboratories in both China and Singapore. In fact, Clearstone was the first dedicated and CAP-certified central lab in China, and continues to be a market leader in this region after 15 years of service. 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. We recently moved to a new state-of-the-art facility in Beijing with five times the capacity and have expanded our test menu with an extensive pharmacogenomics offering – creating a new global centre of excellence within Clearstone for specific testing and biomarker development. LabCorp has also made a series of investments to ensure this lab retains its world-class leadership position in the region.
APOLLO: Clearstone also provides clients with a unique and state-of-the-art central lab protocol management platform, APOLLO. This is a truly global and integrated platform with realtime access from all our operations, and 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.
Scientific Advantage: The recent LabCorp acquisition provides our clients with unparalleled scientific capabilities and expertise that will translate into long-term value now and in the future as we discuss biomarker development and companion diagnostic strategies with sponsors.
Flexibility: We also pride ourselves on our flexibility. Clearstone’s Project Management group works closely with the functional operational teams to ensure that all our clinical trials have been set up to meet the specific requirements of each study. This is further facilitated by the APOLLO 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 more quickly.

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. Therefore we need to work closely with third-party couriers to help them understand our clients’ requirements 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, and 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.

Overall, central labs need to shift from what is perceived as a commodity service to provide more engaged relationships with 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 that our data management group must be at the forefront of laboratory data integration.

Q. What are your future 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 our new relationship with LabCorp creates an exciting opportunity to lead the market in terms of combined scientific capabilities and expertise.

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, 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.

For more information, visit www.clearstonelabs.com