About Q-Pharm
Founded in 2002, Q-Pharm specialises in the conduct of early phase (Phases 1 and 2) clinical trials, bioequivalence, bioavailability and vaccine studies. These studies are conducted in our state-of-the-art facility within the QIMR Berghofer precinct at the Royal Brisbane and Women’s Hospital, Brisbane, Australia.
Our 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 us to understand the needs of our diverse range of clients and deliver on time the highest quality clinical services to satisfy client needs.
How Q-Pharm can help you
Safety
Participant safety is our top priority and our experienced medical staff are continuously trained in the latest medical practices to ensure the highest safety standards. Q-Pharm is located on the campus of one of Queensland's largest teaching hospitals and has direct access to the emergency response unit.
Quality
The quality of our clinical practices have passed multiple audits by the FDA, ANSM, AEMPS and ANVISA. Regular international sponsor audits of the site ensure compliance with GCP.
Speed
Our teams experience will facilitate fast and efficient regulatory (CTN) submission through the Australian regulator (TGA). Q-Pharm has access to two local HRECs for ethics approvals to provide expedient trial startup times.
Cost
Let us help you with the development of your study protocol to make your study run as cost efficient as possible. Clinical trials with Q-Pharm can cost up to 30% less than USA based trials.
Experience is everything, and Q-Pharm has the numbers to prove it
Early Phase Studies
We have successfully completed over 400 studies in both healthy and patient populations.
of clinical trials
Q-Pharm has over 15 years’ experience in conducting complex early phase clinical trials
15k + participants
We have had over 15,000 volunteers participate in our clinical trials.
Early Phase Clinical Trial Specialists
Q-Pharm provides comprehensive trial services to its clients
First-in-man studies
With over 40 first-in-man studies under our belt you can be sure your trial is in good hands
Healthy and patient based studies
Connections with local hospitals and specialists gives us access to patients all around Queensland with specific health conditions
Proven quality system
At Q-Pharm, quality is and always has been at the heart of everything we do
Specialised Expertise
Q-Pharm has specialised expertise in a great number of therapeutic areas
Recruitment
Streamlined recruitment process, 10,000+ active participants in database
Our Services & Solutions
As a reputable partner to the biopharmaceutical industry, Q-Pharm knows the challenges you face today and are ready to help your trial run in cost-efficient and timely manner.
We provide:
- Consultation and advice on protocol development
- Management of ethics submission and approval
- Participant Information and consent form writing and review
- Laboratory and data management planning and set-up
- Vendor coordination (local pathology laboratory and other suppliers)
- Onsite pharmacy services
- Development of pharmacy manuals
- Advice on safety, preperation, handling and storage of IP
Local Human Research Ethics Committee (HREC) Submission and Meeting Dates:
- First-in-man studies, including both single and multiple ascending dose designs
- Pharmacokinetic studies which support formulation development activities such as food effect studies and drug-drug interaction studies
- Bioavailability and bioequivalence studies which have gained successful product registrations in a diverse range of markets such as USA, UK, Europe, Middle-East, and the greater Asia-Pacific region
- Small molecule and biological agents, early stage PK/PD assessments and complex early stage vaccine trials (including GMOs)
- Trials requiring novel device design or various routes of administration
- Out-/in-patient and long confinement trials
At Q-Pharm we take pride in our recruitment team and in our volunteers. Brisbane is an excellent location to find a diverse population for any variation of clinical trials. Close connections with universities and medical institutions provides us with a great number of active signups each month.
Our current database holds 10,000+ volunteers with a 50/50 split in males and females. Q-Pharm has a long standing relationship with Brisbane and our volunteers know that their safety and well-being is always a priority.
Q-Pharm maintains a strategic relationship with Australian bio-analytical laboratory, TetraQ Research Infrastructure Centre (www.tetraq.com.au), who provide comprehensive drug analysis capabilities to support complex pharmacokinetic studies in the broad range of early phase trials conducted at Q-Pharm. Q-Pharm also collaborates with external pathology providers for electronic reporting of a variety of other laboratory testing requirements.
The co-location of Q-Pharm and TetraQ within the campus of the Royal Brisbane and Women's Hospital facilitates rapid turnaround of pharmacokinetic results for studies that require PK data for dose escalation decisions and safety review committees.
TetraQ and other pathology partners are NATA accredited for both GLP and compliance with ISO/IEC 17025 and provide analytical services acceptable in any regulatory domain.
Our Facilities
Mervyn-Eadie Clinic
Our 24-bed clinic ideally suited to large-panel healthy volunteer studies and early phase studies.
Wayne-Hooper Clinic
Our 6-bed open plan ward and outpatient area with 5 private rooms useful for short-term trials.
Clinical Laboratory
Our clinics are supported by a well-equipped clinic laboratory and experienced staff.
Pharmacy
Q-Pharm currently has an on-site pharmacy, facilitating drug preparation on-site.