Details
- Organisation Name: Cholesterol Care Australia
- HHS: N/A
- Services Offered: 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.cholesterolcare.com.au
- Contact: studycoordinator@cholesterolcare.net
- Other Affiliated Research Sites: N/A
Location
-27.48732719325615, 153.02907616136238
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?
1 week
Site Overview
Cholesterol Care Australia is a small but highly effective Specialist run team who coordinate cholesterol/cardiovascular sponsor clinical trials from start to finish. We have over 20 years in clinical trial knowledge and provide expert care to our participants.
HREC
- HREC Committee Name: Bellberry Limited
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Sponsor Provided Central
- Mandate distribution of safety: Yes
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Sponsor Provided Central
- Mandate distribution of safety: Yes
Facility staffing and training
- Handling Investigational Product:
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site:
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site:
Licenses to receive, store, dispense and return controlled substances
- Required Licenses or Registrations: Not Applicable
- 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:
- Centrifuge: Yes
- Refrigerated Centrifuge: No
- Centrifuge: Yes
- Refrigerated Centrifuge: No
Patient Records
- Record Archiving:
- EMR/EHR systems:
- Has your Clinical Trial Site or Service been accredited? not applicable
- Audit Type: Sponsor, Other
- EMR/EHR systems:
- Has your Clinical Trial Site or Service been accredited? not applicable
- Audit Type: Sponsor, 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): No
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): No
- Does this equipment have back-up power? No
- 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): No
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): No
- Does this equipment have back-up power? No
- 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
Cardiovascular Diseases
Medicine
Study Types
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
Does your Facility support in-patient admissions?
Not Applicable
PK & PD specimens
Yes
Study Phase Capability
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
ECG/EKG Electrocardiogram
MRI Magnetic Resonance Imaging
Ultrasound
X-Ray