Founded in 2002, Q-Pharm is wholly owned by Nucleus Network, Australia’s largest Phase 1 Clinical Trials specialist.
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.
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.
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.