National Association of Testing Authorities, Australia
Scope of Accreditation
Prove Clinical Laboratories Pty Ltd
Site
Prove Clinical Laboratories Pty Ltd
Accreditation No.
20810
Site No.
24972
Date of Accreditation
10 Jun 2021
Contact
Ms Ariningsun Cinantya P: +61 (02) 91910640
Availability
Services available to external clients
Scope of Accreditation
Prove Clinical Laboratories Pty Ltd
ISO/IEC 17025 (2017)
Healthcare, Pharmaceutical and Media Products
| Service | Product | Determinant | Technique | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analysis in support of clinical trials and/or pre-clinical studies | Human biological samples | Concentration of drug and/or biological agents; Detection and characterisation of biological agents; Pharmacodynamics (PD) parameters; Pharmacokinetic (PK) parameters; Specialised pharmacodynamic studies | Enzyme linked immunosorbent assay (ELISA) - Immunoassay; HPLC; LC-MS-MS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Capability Methods validated to FDA and EMA bioanalytical method validation guidances and/or industry consensus white papers. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ISO/IEC 17025 (2017)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Routine non-diagnostic analysis in support of clinical trials - Chemical Pathology | Plasma; Serum | Analytes for hepatic, cardiac, bone, lipid, renal, skeletal muscle and other profiles and metabolic studies |
| Serum | Analytes for hepatic, cardiac, bone, lipid, renal, skeletal muscle and other profiles and metabolic studies; Hormones | |
| Routine non-diagnostic analysis in support of clinical trials - Haematology | Blood | Blood counts |
| Plasma | Haemostasis related tests | |
| Routine non-diagnostic analysis in support of clinical trials - Microbiology | Serum | Serology of infection |
| Urine | Dipstick tests |
The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
20810
Site No.
24972
Print date
28 Nov 2024
END OF SCOPE