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
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.
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.
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.
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 380 studies in both healthy and patient populations.
of clinical trials
Q-Pharm has over 14 years’ experience in conducting complex early phase clinical trials
15k + participants
We have had over 15,000 volunteers participate in our clinical trials.
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.
- 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.
Mervyn Eadie Clinic
Commissioned in March of 2009, this 24 bed clinic is ideally suited to large-panel healthy volunteer studies. The flexible design of the facility also allows it to be used for other early phase studies requiring intense monitoring of trial participants.
Primary features of the clinic include:
- Open plan 24 bed clinical trial ward with cardiac monitoring (telemetry including ECG / NiBP / SpO2)
- Amenities include separate dining, kitchen and recreation areas
- Synchronized digital clocks
- Processing laboratory
- Emergency trolleys and access to RBWH emergency services
- Access to ancillary support services (eg catering, nutrition, cleaning etc.)
This facility also hosts modern entertainment facilities for volunteers including;
- Reading room / computer room
- Games room
- Cable television
- Wireless internet
Wayne Hooper Clinic
- A 6-bed open plan ward and outpatient area with patient monitoring and telemetry to all beds.
- 5 private rooms (that can be used as either single or twin-bed), each with ensuite, and equipped with patient monitoring and telemetry to all beds.
The outpatient area /open plan ward can also be used for short-term trials, with subjects not requiring a high level of nursing support. These facilities are supported by all ancillary services, including:
- Special procedures room for biopsies or minor clinical procedures
- Doctors’ consulting rooms
- Clinical data management areas
- Subjects’ lounge
- Catering facilities
- Secure well appointed pharmacy (registered with the state authority)
- PC2 Clinic Laboratory
- Subject recreation areas and entertainment (cable television, wireless internet)
- Emergency trolleys & immediate access to emergency response team
- Access to ancillary support services (eg catering, nutrition, cleaning etc.)
Each of our clinics is supported by a well equipped clinic laboratory and experienced staff. Q-Pharm laboratory staff have extensive experience in clinical laboratory work, with proficiency in the processing of PK, PD and Phase 1 study samples (e.g. pre-analytical samples, tissue biopsies, PBMC’s, genotype samples, etc). Our laboratory staff are also IATA trained ensuring that all shipped samples are prepared and packaged to the highest standards.
Our clinical laboratory has a comprehensive range of laboratory equipment including:
- -20oC Freezers, -70oC Freezers, and Refrigerators
(continually temperature monitored and on back-up power)
- Refrigerated bench top centrifuges
- Biosafety cabinet
- Bench top vortexes
- Wet ice, dry ice, and liquid nitrogen supply
- Deionized water supply
- Urine drug screening
- Alcohol breath testing
- Pregnancy testing
Q-Pharm’s location on the site of the QIMR Berghofer Medical Research Institute and Royal Brisbane and Women’s Hospital enables easy access to many other specialist laboratories and equipment if required.
Q-Pharm currently has an on-site pharmacy. This allows us to do drug preparation on-site with hand-over straight to administrators resulting in on-time dosing and dispensing.
This is especially useful for drugs that have a short expiry life or when IP's need to be mixed with vehicle at the patient bedside.
Specific on-site equipment includes:
- -20C, -70C, 2-80C Fridges/freezers with 24/7 on- and offsite monitoring
- Room temperature storage rooms
Q-Pharm enjoys many advantages of location and affiliation, being on the campus of the Royal Brisbane and Women’s Hospital (RBWH). RBWH is a quaternary and tertiary referral teaching hospital located at the Metro North Hospital and Health Service (MNHHS) Herston site, close to the Brisbane CBD. RBWH provides state-of-the-art health care services for more than one tenth of all patient services in Queensland.
The RBWH has 929 beds and this affiliation provides Q-Pharm with ready access to emergency services, specialised facilities and specialist clinical collaborators for recruitment of clinical studies requiring patients.
For directions on how to find us on the hospital campus, please click this link.