CentraLabS Clinical Research is an emerging force supporting global drug development in the pharmaceutical industry. Part of the Life Sciences Research group of companies, CentraLabS has evolved from the clinical laboratory services arm of one of the worlds longest established CROs. This has allowed CentraLabS to utilise its extensive analytical experience to provide focus and dedicated support to all stages of clinical drug development.

Our group company has over 30 years experience in providing analytical support for clinical studies to the pharmaceutical industry. CentraLabS Clinical Research began its operations in the 1990s when the clinical pathology laboratories of Ciba-Geigy Pharmaceuticals UK were acquired. At that time Life Sciences had been supporting Phase I studies for at least five years. These two laboratories were consolidated in the east of England during 1998 and the Central Laboratory Services group was born.

Over the last 5 years we have expanded the scope of our analytical service to include logistics, project and data management to support full global clinical trials. In 2000 our USA clinical laboratory in Princeton New Jersey came on line and in 2001 we launched our global operation under the CentraLabS Clinical Research name.

Working in modern laboratories with purpose-designed and state of the art equipment, our teams of technical and scientific experts produce data that will meet the most exacting regulatory requirements. The quality of their work is reflected in a history of compliance with Good Laboratory Practice (GLP) dating back to 1977.

With a completely flexible approach to working with our sponsors CentraLabS can provide additional capacity to meet a short term increase in workload or undertake the complete management of the study using experienced project co-ordination staff. Therefore, however great or little the task, we can ensure it is performed on time, correct in all its details and reported in a form that is immediately acceptable to regulatory authorities.

Mission Statement

To provide a comprehensive range of integrated development services which are recognised to be of superior value by our customers in the pharmaceutical industry. This is by enhancing regulatory acceptance, speed to market and return on investment of their products.

Business Development Strategy

• Consolidate market leadership for clinical testing across current customer base
• Extend services to support clinical development
• Introduce additional services to support clinical sample testing
• Enhance range of services and expertise to support drug compound development

Our Global Service - with local knowledge

In addition to our own USA and UK laboratories we have alliance partner laboratories in South East Asia, South Africa, South America, Australia and China. One of our goals at CentraLabS is to build an extensive "family" of regional laboratories that are fully cross-validated, combined with local project management, working seamlessly together to support both your regional and global trials. Our experience in the logistics of local and global project management ensures the highest levels of scientific integrity, and a timely completion of your projects. Our professional staff have the expertise to provide the complete range of essential drug development services and integrated clinical solutions:

• High throughput clinical analysis with on-line data capture
• Extensive in-house specialty testing and esoteric capability
• Specimen management, sample tracking and storage systems
• Global logistics and investigator support services, including kit production and investigator training
• Flexible data management and rapid reporting system (ClinAxys II)
• Dedicated project management and client support services
• Full bioanalytical capability from method development to sample analysis (LC/MS/MS, HPLC, GC, GC/MS)
• Clinical pharmacokinetics support
• Analytical support for Phase I - IV
• Allows sample tracking, demographic clean-up and rapid data turnaround

Main Analytical Technologies:

• LC-MS/MS
• HPLC
• Protein Chemistry
• Protein characterisation
• Immunoassay
• GC
• GC/MS
• Capillary Electrophoresis
• Quantitative PCR

Experience and expertise:

• Over 3 decades of analytical experience
• Broad range of therapeutic areas supported

Development & regulatory expertise:

• Approximately 80% of our methods developed in-house
• Rapid method establishment (feasibility approach, defined milestones)
• Key scientists on Regulatory review panels
• Quality of our data
• Our reports are commonly submitted to the regulatory authorities
• Regularly audited by external bodies and our clients

Capacity to respond:

• Sufficient staff and equipment to meet tight deadlines
• 7 day week operation

Project Management:

• Single point of contact
• Seamless integration of services by use of Program Manager
• Team structure for project continuity

Dedicated logistical support group:

• Study sample tracking and courier support.
• Kit boxes and request forms

Flexibility of service:

• Validations not written in stone "clients right"
• Flexible report formats (electronic, or hard copy)
• Fast sample turnarounds if required (QA audited)

Global Laboratory Coverage:

• Bioanalytical Services available to support global clinical studies
• Cross laboratory validation

Facts and Figures:

• Group company total employees > 1400 world-wide
• CentraLabS has approximately 100 dedicated clinical staff world-wide
• Group Company turnover of $ 85M per year
• CentraLabS Clinical revenues growth averages 100% year on year since 1999
• Audited annually by FDA, MCA and all other international regulatory bodies
• Trades on US OTC market as "LSRI"
• Group company works with 8 out of top 10 pharmaceutical companies world-wide

Corporate Headquarters

CentraLabS Clinical Research
100 Mettlers Road
East Millstone
New Jersey
08875-2360
USA

Europe

CentraLabS Clinical Research
Woolley Road
Alconbury
Cambridgeshire
PE28 4HS

Email: info@centralabs.com

Website: www.centralabs.com

Contact Information

CentraLabS Clinical Research
Business Development
Woolley Road, Alconbury
Cambridgeshire PE28 4HS United Kingdom
Phone: +44 (0) 1480 892 000
Fax: +44 (0) 1480 892 205
E-mail:

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