Details
- Organisation Name: Nucleus Network Pty Ltd
- HHS: N/A
- Services Offered: Early Phase, Clinical trials site, Phase 1 unit, Trial Patient Recruitment, Completion of study documentation as per ICH GCP and contract
- Website Address: https://www.nucleusnetwork.com/au/
- Contact: Biljana Georgievska - [email protected]
- Other Affiliated Research Sites: Other Nucleus sites
Location
-27.448675785146172, 153.02983773645755
Initiating study activities approval
No
Review required
Greater than 2 weeks
Site Overview
Nucleus Network Australia's largest Phase 1 clinical trials specialist, and the only multi-site phase I clinical trials provider located in both Australia and the USA. We provide high-quality, first-in-human and early-phase trials for biotechnology and pharmaceutical companies across the USA, Europe and Asia. Located within cutting-edge health precincts, our cost-effective, accelerated clinical development solutions are supported by advanced technology, clinical excellence, and research expertise. We have a large Healthy Volunteer database.
HREC
- HREC Committee Name:
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local
- Mandate distribution of safety: Yes
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: 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? Yes
- Does the Facility have the ability to handle radio-labelled Investigational Products? Yes
Equipment
- Investigational Product: Horizontal laminar flow hood (non-hazardous drug preparation)
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving: Yes
- EMR/EHR systems: In-house
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: FDA ( Food Drug Administration), Other
- EMR/EHR systems: In-house
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: FDA ( Food Drug Administration), Other
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
Bacterial Infections and Mycoses
Cardiovascular Diseases
Digestive System Diseases
Endocrine System Diseases
Eye Diseases
Immune System Diseases
Mental Disorders
Musculoskeletal Diseases
Nervous System Diseases
Nutritional and Metabolic Diseases
Respiratory Tract Diseases
Skin and Connective Tissue Diseases
Virus Diseases
Study Types
Industry
Source Document Types
Paper and Electronic
Has your Clinical Trials Site or Service been audited by:
FDA
Sponsor
Average time to start study (in calendar days)
30-60
How long prior to HREC meeting does the application need to be submitted?
2 weeks
Support in-patient admissions
Yes
PK & PD specimens
Yes
Study Phase Capability
First in Human
Phase I
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
ECG/EKG Electrocardiogram
MRI Magnetic Resonance Imaging
Other
X-Ray
Patient Population
Adults - Ages 18-64
Healthy Volunteers