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
