Q-Pharm

Contact Information

Craig Hurren
Chief Commercial Officer
Q-Pharm
Level 5, 300c Herston Road
Herston, Queensland, Australia  4006
+61487166677
Enquiries@qpharm.com.au
qpharm.com.au

Company overview

Q-Pharm is a state-of-the-art early-phase clinical trials company providing a broad range of high-quality services for commercial and academic clients from around the world. Since 2002, Q-Pharm has safely and successfully conducted more than 400 early-phase clinical trials in a wide variety of therapeutic areas. Q-Pharm’s highly qualified teams and leaders have a wealth of experience in clinical development, enabling Q-Pharm to understand the needs of a diverse range of clients, and to meet and exceed their expectations. Clinical trials conducted at Q-Pharm are accepted by regulators throughout the world, including Australia, Europe, Asia, and the Americas. Q-Pharm’s speciality clinical trial services include: Comparative PK/PD, SAD/MAD/Food Effect studies, complex First-In-Human studies, vaccines studies, disease challenge models, clinical development strategy and study design consultation.

Q-Pharm’s experience with comparative pharmacokinetic studies is unrivalled in the region. Our experience base includes:

  • Complex designs (steady-state, 3-way and 4-way crossover studies)
  • Early stage vaccine trials (including GMOs)
  • Large early phase studies (up to 120 volunteers)
  • Unconventional study designs
  • Extensive experience with food effect studies

    Our experience

    Q-Pharm is at the forefront of innovation within the pharmaceutical and biotech industry. Together with our clients we have completed many complex trials including ones solving contemporary diseases and viruses such as Ebola and Hendra as well as using innovative technology such as Needle-free Nanopatch technology.

    In collaboration with a diverse range of local and international clients, Q-Pharm has completed hundreds of innovative and complex trials in a broad range of therapeutic areas, ranging from contemporary diseases such as Ebola and Hendra to cutting-edge medical devices like needle-free Nanopatch delivery technology.

     
  • First in human
  • Gastroenterology
  • BA/BE/PK studies
  • Infectious Diseases
  • Proof of Concept studies
  • Dermatology
  • SAD/MAD/Food effect studies
  • Respiratory
  • Long term confinements (28 days+)
  • Anaesthesia
  • Infectious agent – vaccines and therapeutics
  • Cardiovascular
  • Anaesthetic agents
  • CNS/Neurology
  • Malaria challenge models
  • Endocrinology
  • Obesity
  • Gynaecology
  • Glucose clamp
  • Haematology
  • Cytotoxic agents and immuno-oncology
  • Medical Imaging
  • Medical devices
  • Oncology
  • Inhaled deliveries/devices
  • Orthopaedics
  • Novel vaccine delivery
  • Psychiatry
  • Ethnobridging & other ethnopharmacology studies
  • Renal
  • Vaccine studies
  • Rheumatology

Products and Services

Advice on Study Design, Logistics, Conduct and Coordination of Ethics Submission

  • 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, preparation, handling and storage of IP

Conduct of Clinical Studies

  • First-in-human 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
  • Recruitment services
  • Bioanalytical services

    Facilities

  • 62 bed clinic including 5 private rooms with en-suite bathrooms.
  • Recreational areas, Wi-Fi, video games, television, movies, etc. for participant entertainment,
  • Separate kitchen and dining facilities, laundry facilities, separate men’s and women’s shower and toilet facilities,
  • Synchronized clocks, telemetry including ECG, NiBP, SpO2,
  • Processing laboratories including PC2, hospital grade plumbing with oxygen, suction, etc.,
  • Consulting/examination rooms, secured pharmacy storage and dispensary, extemporaneous compounding pharmacy,
  • Emergency trolleys and direct access to Emergency Response Team and other ancillary hospital services.

    Why Australia?

  • Trials conducted to Australian standards are accepted by all major global regulatory bodies (FDA, EMA, MHRA, ANVISA, etc.)
  • A safe and stable, low-risk location for conducting clinical trials.
  • Fast and efficient approval conditions (CTN, HRECs) and costs.
  • A strong history and reputation in discovery and clinical development.
  • Clinical trials with Q-Pharm can cost up to 30% less than USA-based trials.
  • Australia’s Quality of Science Research Institutions ranked 8th out of 148 economies
  • Australia’s CSIRO ranks in the top 1% of world scientific institutions

Contact Information

Craig Hurren
Chief Commercial Officer
Q-Pharm
Level 5, 300c Herston Road
Herston, Queensland, Australia  4006
+61487166677
Enquiries@qpharm.com.au
qpharm.com.au

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