About Q-Pharm

Company Overview

Founded in 2002, Q-Pharm is a private company, wholly owned by the QIMR Berghofer Medical Research Institute.

Q-Pharm specialises in the conduct of early phase (Phases 1 and 2) clinical trials, bioequivalence & bioavailability studies and vaccine studies. These studies are conducted in a state-of-the-art facility within the QIMR Berghofer precinct at the Royal Brisbane and Women’s Hospital, Brisbane, Australia. The company provides a comprehensive, high quality service to our clients, and conducts clinical trials in accordance with all applicable national and international standards and guidelines. Q-Pharm’s strength is its highly-qualified clinical trial team, whose leaders have a wealth of experience in clinical development. This experience enables Q-Pharm to understand the needs of our diverse range of clients and thereby deliver on time the highest quality clinical services to satisfy client needs.

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Accomplishments

Many of the clinical studies conducted at Q-Pharm have been accepted for submission to regulators in Australasia, Europe and the Americas. Q-Pharm also has a history of successful regulatory inspections and many client audits. Inspections have come from North America (FDA in 2007), South America (ANVISA in 2003, 2006 and 2008), and Australia.

Experience

Q-Pharm has over 15 years of experience in healthy volunteer and patient studies from first time in human through to Phase 3 and the founders had over 20 years of prior experience. We have conducted studies using biological agents, vaccines and pharmaceutical agents using a range of delivery modalities including oral, intra-venous, sub-cutaneous, intradermal, implant, inhalation and trans-dermal routes of administration.

Our personnel have been responsible for the management and conduct of over 400 early phase studies. The company attracts a large number of local and international clients, particularly from the United States and Europe. Q-Pharm’s facilities and experience in this sector are unrivalled in the region. The experience base includes complex early phase studies (adaptive design first-in-human studies, 3- and 4-way crossover studies, steady-state studies), very large studies (up to 120 volunteers), unconventional study designs (urinary recovery or indirect assessments via pharmacodynamic parameters), and extensive experience with food effect studies.

Our Client Base

Q-Pharm services an international client base.  During its years of operation the company has grown from servicing Australian clients only, to one that has a majority of customers that are based overseas.

This international client base has been built upon the premise of delivering quality clinical trial solutions with a thorough understanding of our customer's regulatory needs and requirements.

Q-Pharm works with Pharmaceutical, Biotechnology and Device Industries.  A substantial proportion of our new projects are repeat business or referrals from satisfied clients.

While the majority of these clients approach  Q-Pharm directly for clinical trial services, a significant number of projects are also brought to  Q-Pharm via our partner clinical research organisations.