Capabilities

Services

Established in 1995, SydPath Clinical Trials has successfully established an international reputation for the provision of quality, central-laboratory services.

Our experienced and professional staff will support every aspect of your research and development.

Our services include:

  1. Study Management

    • A dedicated Project Manager is assigned to each study and liaises with sponsors, investigator sites, business development and laboratory staff throughout the course of the clinical trial to ensure that the study and client receives the best possible service.
  2. Data Management

    • Our data management team proceedure clean data and comprehensive specialised reports. These reports can be client specific and distributed. Our data managers can build report formats and distribute these according to the client’s specifications.
    • Electronic data can be submitted in sponsor-defined formats and is available online in a printable format. All transmissions are randomly audited to ensure the data integrity.
    • SydPath’s CTRM (Clinical Trials Reporting Module) system allows real time access to your study data via a secure online portal which can be accessed via the most popular web browsers including Microsoft Internet Explorer®, Firefox® and Google Chrome®.

    The CTRM is directly linked to our Clinical Trials Oracle Database which receives real time data feeds from our Laboratory Information System (LIMS), allowing you continuous access to your data, direct from the source. The benefit of this system is its ability to provide you with study-specific requirements, including study-specific references ranges, alerts or data blinding.

  3. Logistics & Specimen Management

    • Our Logistics and Specimen Management Team can provide all aspects of your study needs from request forms, packaging materials, pre-printed airway bills, kit build/supply and resupply, study manuals and other preparative equipment as requested.
  4. Quality Assurance

    • Fully compliant with Government regulations, including the requirements of ISO 15189
    • TGA Licensed and NATA Accredited
    • Relevant principles of ICH GCP, OECD GLP are followed
    • Follow relevant principles of ICH GCP, OECD GLP
    • GMP (Human Blood and Blood Components) Licence for Serology, Molecular and Microbiology testing
      Accredited Private APA (Approved Pathology Authority)
  5. Customer Support

    • Our laboratory provides a 24hr,  7 day a week service for receipt of samples, Chemistry and Haematology services.
  6. Additional Services

    • Drug assay development & validation
    • Insurance Testing & Corporate Health Service Testing
    • Pre-employment health checks
  7. Collection Centres

    • SydPath offers a comprehensive pathology collection service;  all of our staff are highly trained and experienced in all aspects of pathology collection.
    • We have a number of HIC approved collection centres located across the eastern states.
    • Our mobile pathology collection service is available for home visits, commercial and clinical trial work, upon request.
  8. Bio-Banking Facility

    • This is a purpose built facility to handle cryogenic fluids, pressurised gases and biologically hazardous samples. The facility comprises of three high capacity MVE 1894 vapour phase liquid nitrogen freezers along with twenty -80 degree Celsius  freezers that are connected and monitored as per regulations.