Details
- Organisation Name: Core Research Group Pty Ltd
- HHS: N/A
- Services Offered: Early Phase, Complementary medicines clinical trials, Clinical trials site, Trial Patient Recruitment, Treatment of patients
- Website Address: www.coreresearchgroup.com
- Contact: d.colquhoun@uq.edu.au
- Other Affiliated Research Sites: Yes
Location
-27.472329717072764, 153.0010185153406
Initiating study activities approval
Yes
Review required
1 week
Site Overview
Core Research Group specialises is own and run by a consultant cardiologist and has successfully run clinical trials for almost 30 years. We run clinical trials in all areas of cardiology, lipids, diabetes, obesity, chronic kidney disease, non-alcoholic liver diseases and internal medicine more generally.
HREC
- HREC Committee Name: Bellberry Limited
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Central Acting as Local
- Mandate distribution of safety: No
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Central Acting as Local
- Mandate distribution of safety: No
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? Yes
- Does the Facility have the ability to handle radio-labelled Investigational Products? Yes
Equipment
- Investigational Product: Extemporaneous Preparation
- 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? Yes
- Audit Type: CRO ( Clinical Research Organisation), Sponsor
- EMR/EHR systems: Other
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: CRO ( Clinical Research Organisation), Sponsor
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
Atherosclerosis
Cardiology
Cardiovascular Diseases
Chronic Kidney Disease
Diabetes
Endocrine System Diseases
Liver Disease
Medicine
Nutritional and Metabolic Diseases
Respiratory Tract Diseases
Study Types
Academic
Industry
Investigator
Source Document Types
Paper
Average time to start study (in calendar days)
Less than 30
How long prior to HREC meeting does the application need to be submitted?
1 week
Does the HREC committee require contract /budget approval prior to release final approval documents?
No
Support in-patient admissions
Yes
PK & PD specimens
Yes
Study Phase Capability
Device Pivotal
Device Post Approval
Phase II
Phase III
Phase IV
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
PET Positron Emission Tomography Scan
SPECT
Thallium cardiac stress test
Thyroid scan
X-Ray
Patient Population
Healthy Volunteers
Adolescents/Adults 16 and onwards
Adults 18 and onwards
Geriatrics 65 and onwards