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Our Services
Q-Pharm Pty Limited offers a wide range of high-quality services including:
We provide a comprehensive, high quality service to our clients, and conduct clinical trials in accordance with applicable national and international standards and guidelines. Our studies are conducted with the rigor of scientific process, and we are committed to providing excellence in our service.
Phase I and II Clinical Trials
Q-Pharm conducts Phase I and II clinical trials, or more specifically:
- Safety and tolerability clinical studies of new drug candidates;
- Pharmacokinetic studies; and
- Drug Interaction Studies
Q-Pharm is able to operate its state-of-the-art clinical trial unit as an inpatient or outpatient facility, and it is supported by all ancillary services required to conduct clinical trials. Through an established network of clinical associates, Q-Pharm is able to recruit patient panels for a wide variety of trials.
Q-Pharm has conducted clinical trials on drugs covering many therapeutic areas, many in healthy volunteers, but an increasing number of trials are being conducted in specially recruited patients.
Q-Pharm has conducted studies using Biological agents, Vaccines and Pharmaceutical agents using a range of delivery modalities including tablet, capsule, intra-venous, sub-cutaneous, implant, inhalation and trans-dermal routes of administration.
Our highly qualified clinical trial team is dedicated to delivering innovative solutions to this wide-ranging and complex area, while adhering to strict time commitments.
Bioequivalence Studies
Q-Pharm is the leading provider of bioequivalence studies in the region. The company has experience with standard 2-way crossover studies and also with more challenging 3-way and 4-way crossover designs. Studies have been conducted in panels of subjects ranging from 12 to over 100 in number.
We have extensive experience with food effect studies. On the basis of our extensive experience, Q-Pharm can assist clients with study design, protocol writing and all aspects of conducting the clinical and analytical studies. We also offer comprehensive pharmacokinetic and statistical analysis and study report writing.
Drug Analysis
Q-Pharm’s drug analysis laboratory is designed to complement our clinical activities. However, drug analysis is also performed in support of clinical trials not performed in-house.
The drug analysis laboratory is able to undertake the analysis of various clinical samples including plasma and urine. The laboratory is equipped with
three HPLC/MS-MS’s, a GC/MS and six HPLC’s with a full range of detector options. Q-Pharm also has access to other analytical capabilities.
Q-Pharm’s drug analysis laboratory has extensive experience with a wide-variety of pharmaceutical products, and is also able to undertake the development and validation of new analytical methods, as required. The laboratory has validated analytical methods for the assay of more than 100 drugs and drug metabolites.
The laboratory holds NATA accreditation as a Medical Testing laboratory which recognises compliance with ISO/IEC 17025/1999. A comprehensive quality assurance and process improvement system is in place.
The analytical team is committed to producing results that have withstood the rigours of scientific process, and are dedicated to excellence in research.
Comprehensive Services
Q-Pharm is able to provide a comprehensive service to its clients, including:
- Study Design
- Protocol Writing
- Laboratory Analysis
- Data Analysis, and
- Report Writing
- Clinic Activities
Q-Pharm is dedicated to providing a high quality service, while adhering to strict time commitments.
For more information on any of our other
professional services please email us:
qpharm@qpharm.com.au |
