Services
Our staff of highly experienced professionals will support every aspect of your research and development. Our services include:
1. Study Management 2. Data Management 3. Logistics & Specimen Management 4. Quality Assurance 5. Customer Support 6. Additional ServicesSTUDY MANAGEMENT
Our Project Managers understand both the scientific and management aspects of clinical trial testing. 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. When a client approaches the Clinical Trial Business Unit a project team including Business Development, Project Management and Laboratory Operations is assembled to develop the most flexible and cost effective approach for study conduct. The project manager can also provide project scoping, coordination of all study activities, investigator manuals, presentations at investigators meetings, advice on analysis, KPI’s and reports as required.
DATA MANAGEMENT
Our Data Management Team encompasses dedicated staff with an appropriate mixture of backgrounds including data management, clinical laboratory, information services, and project management. Data management is carried out according to local regulations or as specified by the client. At the core of our Data Management System is our LIMS and ClinTrial. All systems are fully validated. Our dedicated data managers ensure that prior to release of reports that the data is clean the first time. The data managers can build report formats and have these distributed according to the clients specifications. In addition Electronic Data can be submitted in sponsor-defined formats; and all transmissions are randomly audited. The data managers ensure the secure archival of all trial documentation. Absolute data confidentiality is guaranteed.
LOGISTICS AND SPECIMEN MANAGEMENT
Whether the study is Local or International our Logistics and Specimen Management Team ensures that you have complete support and peace of mind. We work with the best courier services available to ensure timely delivery and sample integrity. All clients have the flexibility of choice to use our preferred couriers or their own selected vendors. We ensure a complete communication between couriers, laboratories, investigational sites and the project team. Our Logistics and Specimen Management Team will provide all aspects of your study needs from request forms, packaging materials, pre-printed airway bills, kit build/supply and resupply, centrifuges and other preparative equipment as requested. Our team has years of experience relative to the shipment of diagnostic and infectious samples and the handling and storage of pharmacokinetic and pharmodynamic 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 testing laboratory.
QUALITY ASSURANCE
Our SydPath laboratory is NATA accredited and fully compliant with all Government regulations including the requirements of ISO 15189. SydPath operates under documented SOPs and QA standards and the Quality System is regularly monitored by an Independent Quality department.
CUSTOMER SUPPORT
Our service is 24 hours a day 7 days a week. We have a 24-Hour Help Desk to answer all your trial-related enquiries. We have a decentralised approach to study customer service so that you receive immediate help from the most appropriate staff. All customer service is governed by unified policies and procedures to provide a consistent and harmonised approach. In addition we offer comprehensive training of trial nurses/coordinators in specimen handling, venipuncture, sample processing and transport.
ADDITIONAL SERVICES:
In addition to clinical trials we offer a complete range of pathology services encompassing Insurance & Corporate Testing and Special Laboratory Services.
Insurance Testing & Corporate Health Service Testing
SydPath also offers, through its Clinical Trial Business Unit, competitively priced Insurance and Corporate Testing. This service offers the highest quality and guaranteed fast turnaround times.
Special Laboratory Services
SydPath provides highly specialised tests, including special drug assays, endocrinology, clinical pharmacology and immunopathology laboratory services.
Drug Assay development & Validation
The Bio-analytical Drug Assay Laboratory at SydPath is the NSW State Referral Laboratory for drug monitoring. The laboratory is accredited to ISO 15189 and has been established to Good Laboratory Practice standards. The laboratory has over twenty years experience in quantitative drug analysis and special assay development and validation.