"Excellence in Science, Excellence in Service"

SydPath Central Laboratory Services is located at St Vincent's Hospital, Sydney, a major teaching hospital of the University of NSW.

SydPath is a leading provider in Australia of central laboratory services to the pharmaceutical and biotechnology industry. We service trials running in Australia and New Zealand, as well as other countries in the South East Asia Pacific Rim (including China, Taiwan, Korea, Malaysia, Singapore, Hong Kong, Indonesia, the Philippines, Thailand).

Whether we are operating as a local, central or global laboratory service provider, our Study Management team of highly experienced professionals will support every aspect of your clinical trial.

SydPath has close to 15 years experience in providing central laboratory services to pharmaceutical and biotechnology companies, and our experience is impressive:

• Local, Regional, International Protocols
• Phase I Unit on campus
• Over 480 studies finalised since 1992
• Covers all therapeutic areas
• All areas of clinical research, including cardiothoracic surgery/transplant; cancer research; HIV; endocrinology
• Over 150 running studies
• 250 investigator sites

SydPath is open 24 hours, 7 days a week and boasts an extensive test repertoire:

• 24hr 7 day Central Specimen Reception
• 24hr 7 day Central Laboratory
  • Automated Biochemistry
  • Automated Haematology
  • Automated Immunoassay
  • Coagulation Medicine
  • Transfusion Medicine

Immunochemistry
Immunology, Immunoassay, Flow Cytometry

Special Haematology
Special Coags, Cytogenetics, Cryopreservation

Analytical Chemistry
Special Chemistry, Chromatography, Drug Lab

Microbiology
Bacteriology, Parasitology, Virology & Serology

Anatomical Pathology
Histology, Cytology

Molecular Diagnostics Laboratory
SydPath's Molecular Diagnostics Laboratory is the NSW State Laboratory for HIV/AIDS & Molecular Diagnostic Medicine Laboratory

Centre for Immunology
The CFI carries out internationally renowned research in the areas of immunology and cell biology with relevance to allergy, inflammatory disease and HIV/AIDS. Collaborative projects link these studies to clinical trials in clinical areas, in particular HIV/AIDS

Project Management

Our team of highly experienced professionals will support every aspect of your clinical trial to deliver a successful outcome. A dedicated Study Coordinator is assigned to each protocol and has personal responsibility for:

• Preparation of trial-specific Investigator Manual for each participating site
• Provision of trial/visit-specific sample collection kits and request forms
• Provision of courier packaging materials and pre-printed IATA-compliant transport documents
• Hire of centrifuges if required
• Coordination of Specimen Management & Sample Storage over a range of temperatures

Customer Service

We understand our clients' requirements for a customised service, tailored to specific protocols. All clients can expect the following minimum service levels:

• 24 Hour Help Desk
• Daily reporting of safety results (within 24-hour turnaround)
• Daily data checks prior to release of the report
• Data queries promptly followed up and logged
• Site queries handled by Study Coordinator or experienced Clinical Trial Assistant
• Request for Initial Kit Supplies issued within 5 working days
• Requests for Kit Re-Supplies issued within 2 working days
• Study Managers are available to attend Investigator/Start-Up Meetings
• Telephone training provided to all sites upon receipt of initial supplies

SydPath's Clinical Trials Data Management Group offers data management services tailored to your specific needs, including:

• IT expertise to facilitate integration with any database
• Client-defined flags (eg phone alerts, delta checks, exclusion flags, reflexive testing)
• Electronic data transfer in client-specific format
• Provision of sponsor-specified hard copy report formats
• Trial Management reporting capabilities (recruitment rates, visit monitoring, inclusion/exclusions)

SydPath's Quality Manager is independent of all laboratories and functions across the organisation, reporting only to the General Manager. The Quality Department has responsibility for the following:

• ISO 17025 accreditation
• TGA accreditation
• Accredited Private APA (Approved Pathology Authority)
• Full compliance with Government regulations, including the requirements of ISO 17025
• Maintenance of SOPs and QA Standards in SydPath's Documentation Control Database
• Participation in external QA Programs
• Training of internal auditors
• Implementation of Annual Internal Audit Schedule

Refer to our website at www.sydpath.com.au to download copies of accreditation certificates, reference ranges for standard trial requirements, and certificates of participation in various External Quality Assurance Programs.

All SydPath's clinical trials staff are highly qualified and experienced in either research or pathology related disciplines.

We recognise that it is the people that make the difference, and our highly qualified and experienced trial assistants and study coordinators receive on-going training at SydPath. Compulsory external training courses include:

• the handling and shipment of infectious samples - biannual (IATA)
• ISO 17025 (NATA)
• GCP awareness (ARCS)

Contact Information

SydPath Central Laboratory Service
Carolyn Cheer
Level 6, Xavier Building
St. Vincent's Hospital
Victoria Street, Darlinghurst
Sydney, New South Wales 2010 Australia
Phone: 61-2-8382-9126
Fax: 61-2-8382-2556
E-mail:

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