SydPath Central Laboratory Central Laboratory Services

SydPath’s central laboratory service was established in 1995, and has quickly established its reputation as a top class provider of central laboratory services within Australia.

Our state-of-the-art laboratories cover all of the major pathology disciplines, while SydPath’s strategic location on the St. Vincent’s Hospital Sydney campus provides our clients with full access to the vast resources of a major teaching hospital.

Clinical trials

SydPath participates in both pharmaceutical – sponsored drug trials and grant-funded research as a local laboratory site for its St. Vincent’s campus based researchers, as well as for locally based GPs. For these studies, we will tailor our services to meet your specific needs, which may include the provision of pathology collection kits, investigator manuals and transport materials.

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:

  • Study management
  • Data management
  • Logistics and specimen management
  • Management
  • Quality assurance
  • Customer support

Clinical study management

  • Dedicated study director to liaise with CRAs, investigating sites and laboratory staff
  • Flexibility to tailor our systems to meet your specific needs
    Studies primed and validated to confirm protocol compliance
  • Presentation at investigator meetings and site initiations as required
  • Investigator manuals including:
    (i) procedures for sample collection, processing, packaging and shipment; and
    (ii) source material such as test schedule, reference ranges, alerts, toxicity flags, reflexive tests and accreditation certificates
  • Visit-specific kits containing all the required sample collection materials

Laboratory data management

Demographic checks are performed prior to release of hard copy reports to ensure that all data is clean the first time

Flexible report formats are designed and distributed according to your specifications. Electronic data is transmitted in sponsor-defined format

Test runs are routinely performed prior to the first EDI transmission, and all subsequent transmissions are randomly audited. There is secure archival of all trial documentation according to TGA GCRP guidelines (1991) or as required by you. We provide guaranteed data confidentiality

Logistics and specimen management

We provide shipment of diagnostic and infectious samples, both ambient and frozen. Courier packaging materials such as shippers, bio-bottles, gel packs, pre-printed airway bills and other shipping documentation are issued to sites prior to commencement of study

A dedicated logistics team packs visit-specific kits for distribution prior to study start-up, and as part of its resupply program. There is a prompt turnaround time guaranteed for additional supplies requested by the sites

Benchtop centrifuges are available for hire and we have specimen handling and storage of pharmacokinetic (PK) and pharmodynamic (PD) samples

Clients are provided with regular specimen management reports, and our inventory management system guarantees the safe consolidation and delivery of these samples to the designated PK testing laboratory

Quality assurance

  • SydPath is NATA accredited and fully compliant with all Government regulations including the requirements of ISO 17025
  • SydPath operates under documented SOPs and QA standards
  • SydPath’s quality system is monitored by an independent quality department, conducting regular internal audits across all of SydPath’s functional units.
  • Clinical trials reports are audited weekly to ensure protocol compliance
  • Weekly chart audits to ensure full protocol compliance

Make an enquiry

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Address
SydPath Central Laboratory

Level 6, Xavier Building

St. Vincent's Hospital

Sydney NSW 2010

Darlinghurst

Other

Australia

+61 2 8382 9119 +61 2 8382 2556<br>Mob: 04 04 048 973 www.sydpath.com

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Regional Offices

SydPath Central Laboratory

Level 6, Xavier Building

St. Vincent's Hospital

Sydney NSW 2010

Darlinghurst

Other

Australia

Rebecca Collins - Acting Operations Manager +61 2 8382 9119 +61 2 8382 2556<br>Mob: 04 04 048 973 www.sydpath.com

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