Details
- Organisation Name: Austrials
- HHS: N/A
- Services Offered: Clinical trials CRO; Clinical trials site; Investigator Initiated Trials; Trial Patient Recruitment; Treatment of patients; Completion of study documentation as per ICH GCP and contract
- Website Address: www.austrials.com.au
- Contact: Managing Director and Principal Investigator Munro Neville - [email protected]
- Other Affiliated Research Sites: Victoria Point; North Ipswich and Morayfield
Location
-27.492435 - 152.98174
Initiating study activities approval
Yes
Review required
1 week
Site Overview
Experts in delivering Phase II-IV interventional studies capturing real world evidence and conducting observational research in the usual clinical setting.
HREC
- HREC Committee Name: Bellberry Human Research Committee
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local
- Mandate distribution of safety: No
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: 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: Yes
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: Yes
Licenses to receive, store, dispense and return controlled substances
- Required Licenses or Registrations: No
- Does the Facility have the ability to handle radio-labelled Investigational Products? Not applicable
- Does the Facility have the ability to handle radio-labelled Investigational Products? Not applicable
Equipment
- Investigational Product: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving: Yes
- EMR/EHR systems: No
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: FDA; CRO; Sponsor
- EMR/EHR systems: No
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: FDA; CRO; 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? Not Sure
- 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? Not Sure
Specialty Research Area
Bacterial Infections and Mycoses
Cardiovascular Diseases
Complementary medicine research
Depression and Anxiety
Digestive System Diseases
Endocrine System Diseases
Endometriosis
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Mental Disorders
Musculoskeletal Diseases
Respiratory Tract Diseases
Skin and Connective Tissue Diseases
Vaccines
Virus Diseases
Study Types
Industry
Source Document Types
Electronic
Paper
Paper and Electronic
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
Support in-patient admissions
No
PK & PD specimens
Yes
Study Phase Capability
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
MAMMO Mammography
MRI Magnetic Resonance Imaging
NMED Nuclear medicine e.g. Bone scan
Thallium cardiac stress test
Thyroid scan
X-Ray
Patient Population
Paediatrics
Healthy Volunteers
Adolescents/Adults 16 and onwards
Adults 18 and onwards
Geriatrics 65 and onwards