Details
- Organisation Name: Gallipoli Medical Research Foundation
- HHS: N/A
- Services Offered: Early Phase, Clinical trials site, Phase 1 unit, Bench research, Trial Patient Recruitment, Treatment of patients, Completion of study documentation as per ICH GCP and contract
- Website Address: www.gallipoliresearch.com.au
- Contact: enquiries.grf@ramsayhealth.com.au
- Other Affiliated Research Sites: Ramsay Clinical Trials Network
Location
-27.5122,153.0454
Is your Facility able to initiate study activities prior to Ethics Committee protocol approval?
Yes
How long before Ethics Committee review is the Submission Packet required?
Greater than 2 weeks
Site Overview
GMRF's Clinical Trials Unit (CTU) is providing patients with access to new and emerging medications in an effort to advance medical care for all.
Our team of specialist research nurses and scientists provide our research partners with first-class conduct, management and coordination of multi-centre national and international clinical research trials. With patient-focussed care at the heart of everything they do.
Our team are currently conducting clinical trials in liver disease, respiratory illness and oncology. Find out more below about getting involved in a GMRF clinical trial or click the button to view our currently recruiting trials.
Speciality Research Areas: Oncology - Gastric, Thyroid, Urological, Ovarian, Prostate, NSCLC/ Lung, Melanoma, Prostate, Colorectal and Solid Tumour Cancers; Haematology - Lymphomas, other leukaemia
Respiratory Diseases - Non Tuberculosis Mycobacterium/ other infections Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), Interstitial Pulmonary Fibrosis, Liver Diseases - NASH, Hepatitis B, Hepatitis C, Haemochromatosis.
Our team of specialist research nurses and scientists provide our research partners with first-class conduct, management and coordination of multi-centre national and international clinical research trials. With patient-focussed care at the heart of everything they do.
Our team are currently conducting clinical trials in liver disease, respiratory illness and oncology. Find out more below about getting involved in a GMRF clinical trial or click the button to view our currently recruiting trials.
Speciality Research Areas: Oncology - Gastric, Thyroid, Urological, Ovarian, Prostate, NSCLC/ Lung, Melanoma, Prostate, Colorectal and Solid Tumour Cancers; Haematology - Lymphomas, other leukaemia
Respiratory Diseases - Non Tuberculosis Mycobacterium/ other infections Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), Interstitial Pulmonary Fibrosis, Liver Diseases - NASH, Hepatitis B, Hepatitis C, Haemochromatosis.
HREC
- HREC Committee Name: Ramsay Health Care Queensland HREC, Bellberry HREC
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Central Acting as Local
- Mandate distribution of safety: Yes
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Central Acting as Local
- Mandate distribution of safety: Yes
Facility staffing and training
- Handling Investigational Product: Yes
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: N/A
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: N/A
Licenses to receive, store, dispense and return controlled substances
- Required Licenses or Registrations: Yes
- Does the Facility have the ability to handle radio-labelled Investigational Products? No
- Does the Facility have the ability to handle radio-labelled Investigational Products? No
Equipment
- Investigational Product: Extemporaneous Preparation, Vertical laminar flow hood (chemo/hazardous drugs)
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving: Yes
- EMR/EHR systems: Other
- Has your Clinical Trial Site or Service been accredited? No
- Audit Type: FDA ( Food Drug Administration)
- EMR/EHR systems: Other
- Has your Clinical Trial Site or Service been accredited? No
- Audit Type: FDA ( Food Drug Administration)
Investigational product storage Capabilities
- Refrigerator (2 to 8 Degrees C): Yes
- Freezer (-20 to -30 Degrees C): Yes
- Investigational Freezer (-70 to -80 Degrees C): Yes
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): No
- Does this equipment have back-up power? Yes
- Does this equipment provide Min/Max Temperature Monitoring? Yes
- Do you have the ability to generate a temperature monitoring log for this equipment? Yes
- Does this equipment have a temperature alarm? Yes
- Do you have an SOP which supports calibration of this equipment? Yes
- Freezer (-20 to -30 Degrees C): Yes
- Investigational Freezer (-70 to -80 Degrees C): Yes
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): No
- Does this equipment have back-up power? Yes
- Does this equipment provide Min/Max Temperature Monitoring? Yes
- Do you have the ability to generate a temperature monitoring log for this equipment? Yes
- Does this equipment have a temperature alarm? Yes
- Do you have an SOP which supports calibration of this equipment? Yes
Specialty Research Area
Chronic Obstructive Pulmonary Disease (COPD)
Colorectal Cancer
Leukaemia
Melanoma
NASH
Osteoporosis
Solid tumours
Study Types
Industry
Investigator
Source Document Types
Paper
Average time to start study (in calendar days)
30-60
How long prior to HREC meeting does the application need to be submitted?
Greater than 2 weeks
Does the HREC committee require contract /budget approval prior to release final approval documents?
Yes
Does your Facility support in-patient admissions?
Yes
PK & PD specimens
Yes
Study Phase Capability
Device Pilot
Phase I
Phase II
Phase III
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
DXA Dual-Energy X-ray Absorptiometry or Bone Densitometry
ECG/EKG Electrocardiogram
FLRO Fluoroscopy
MAMMO Mammography
MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
MRS Magnetic Resonance Spectroscopy
NMED Nuclear medicine e.g. Bone scan
Other
Perfusion CT
SPECT
Thallium cardiac stress test
Thyroid scan
X-Ray