Company Profile
CPR Pharma Services Pty Ltd
Company Overview
CPR Pharma Services Pty Ltd (CPR) is an Australian Contract Research Organisation (CRO) specialising in early phase clinical trials.
CPR offers a synergistic combination of clinical and data management services coupled with a GLP-accredited bioanalytical laboratory.
CPR has vital networks with other Australian service providers in the drug development industry including clinical facilities and close relationships with pharmacokinetic consultants within the University of South Australia.
The broad range of services on offer with CPR and our network with early phase facilities and consultants results in a complete package for early phase clinical trials services that is world class.
We offer:
? Expert & Experienced Staff;
? A Strong Client Focus;
? Timely Delivery;
? Commitment to global pharmaceutical standards such as ICH GCP, GLP and ISO.
Our clinical services include:
? Clinical Project Management,
? Protocol and CRF development,
? Monitoring,
? Data Management using 21 CFR Part 11 compliant databases,
? Statistical analysis and report writing services.
Our laboratory provides:
? Assay Development Services
? Validation assays to global FDA Standards
? Sample analysis for discovery pre-clinical and clinical studies using our API 3000, 4000 and 5500Q mass spec platforms
? State-of-the-art Sciex LC/MS/MS.
CPR has an over-arching Quality Assurance Team for our clinical and bioanalytical services. Our QA staff are BARQA associates and have had overseas training including SQA certification for GLP auditing.
CPR's client portfolio ranges from small biotech and pharma companies conducting their first-in-human trials, to large multi-national pharma companies that outsource clinical programs to Australasia. Our current client base is 30% from Australia, 20% Europe and 50% United States, with 80% repeat business obtained. CPR's experience covers all therapeutic areas.