Participate in a study

Specialist early phase clinical trial company

(Phase I, II and vaccine studies)

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.

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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

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Early Phase Studies

We have successfully completed over 400 studies in both healthy and patient populations.

years

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

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First-in-man studies

With over 40 first-in-man studies under our belt you can be sure your trial is in good hands

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Healthy and patient based studies

Connections with local hospitals and specialists gives us access to patients all around Queensland with specific health conditions

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Proven quality system

At Q-Pharm, quality is and always has been at the heart of everything we do

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Specialised Expertise

Q-Pharm has specialised expertise in a great number of therapeutic areas

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Recruitment

Streamlined recruitment process, 10,000+ active participants in database

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Our Services & Solutions

Advice on study design, logistics, conduct and coordination of ethics submission

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:

QIMR Berghofer Medical Research Institute HREC

Bellberry Limited HREC

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Conduct of clinical studies

  • 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
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Recruitment of trial subjects

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.

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Bio-analytical services via partner laboratories

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.

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Our Facilities

Mervyn-Eadie Clinic

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Our 24-bed clinic ideally suited to large-panel healthy volunteer studies and early phase studies.

Wayne-Hooper Clinic

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Our 6-bed open plan ward and outpatient area with 5 private rooms useful for short-term trials.

Clinical Laboratory

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Our clinics are supported by a well-equipped clinic laboratory and experienced staff.

Pharmacy

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Q-Pharm currently has an on-site pharmacy, facilitating drug preparation on-site.

Client base and testimonials

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.

Leslie J. Williams

President and CEO, ImmusanT Inc.

ImmusanT has conducted several Phase 1 studies with Q-Pharm over the past few years. The studies enrolled patients with celiac disease. Our experience with Q-Pharm has been extremely positive and productive at all levels. The Q-Pharm team has shown they are able to fulfill and surpass their enrollment commitments; the staff is highly professional, pro-active and collegial. It has been a real pleasure to work with Q-Pharm.

Neil Finlayson

CEO, Admedus Immunotherapies

Q-Pharm Pty Ltd is the trial site we chose to conduct two of our HSV-2 vaccine trials. Q-Pharm has the best reputation and most experienced investigators and staff to undertake vaccine studies. The first trial was successfully completed in late 2013 in about 6 months, which was mainly due to the efficient and effective team led by Drs. Paul Griffin and Suzanne Elliott. The second study is currently ongoing and we are equally impressed with Q-Pharm and the dedication and hard work of the staff.

Dr. Angus Forster

Chief Development and Operations Officer, Vaxxas

Vaxxas has performed two early stage clinical studies at Q-Pharm using our novel vaccine delivery technology, the Nanopatch.  We selected Q-Pharm based on the experience of their clinical team in running early stage vaccine studies with skin based delivery.  We found the Q-Pharm team to be very engaged and collaborative in their approach supporting us throughout the trial process from protocol development, ethics submission through to study implementation and reporting. Both studies involved a significant amount of skin assessment and photography and we appreciate the hard work of the clinic and data teams in successfully completing these measurements.

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