Overview of number of trials conducted
Q-Pharm has over nine years experience in healthy volunteer and patient studies from first time in human through to Phase 2. Since 2002, Q-Pharm personnel have been responsible for the conduct of over 350 studies (and over 500 studies as Q-Pharm or its progenitor organisation).
The company has conducted studies using biological agents, vaccines and pharmaceutical agents using a range of delivery modalities including oral, intra-venous, sub-cutaneous, implant, inhalation and trans-dermal routes of administration.
Q-Pharm has extensive experience in a growing range of therapeutic areas including:
- Cardiovascular
- Gastroenterology
- Respiratory Medicine
- Oncology
- Psychiatry
- Anaesthesia
- Orthopaedics
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- Endocrinology
- Infectious Diseases
- Rheumatology
- CNS/Neurology
- Gynaecology
- Medical Imaging
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Q-Pharm’s facilities and experience in this sector are unrivalled in the region. The experience base includes complex designs (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.
Regulatory and client audit (inspection) history
Many of the clinical studies conducted at Q-Pharm have been accepted internationally for submissions to regulators in Australasia, Europe and the Americas. Q-Pharm also has a history of successful regulatory inspections and client audits (at least 3 per year). Inspections by agencies from North America (FDA inspection in 2007), Europe (AFSSAPS (France), AEMPS (Spain) in 2010), South America (ANVISA in 2003, 2006 and 2008) and Australia.
First-time-in-humans studies
Q-Pharm is well experienced with conducting pivotal ‘first time in human’ (FTIH) clinical studies. The company conducts approximately 30 clinical studies per year of which up to 5 are true first-time-in human clinical trials. Some examples of FTIH studies conducted at Q-Pharm can be found here. As can be seen, the company has worked with a variety of product types using various routes of administration.
Areas of special expertise
- Japanese Bridging studies
- Patient based studies
- Vaccine studies
- Malaria therapy studies including malaria challenge studies
- Dose escalation studies
- Telemetry/cardiac monitoring
Please refer to downloadable brochures page for detailed information.
Client base
Q-Pharm operates on a truly international scale. During our years of operation Q-Pharm has grown from a company servicing Australian clients only, to a company whose majority of clients (~75%) are based overseas. Our overseas client base has been built upon the premise of delivering quality clinical trial solutions to our clients and our ability to understand and comply with their regulatory needs and requirements. Our clients come from the 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 clinical research organisations.