Core Research Group Pty Ltd

-27.472329717072764, 153.0010185153406

Yes

1 week

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 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

- Handling Investigational Product: Yes
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: N/A

- Required Licenses or Registrations: Yes
- Does the Facility have the ability to handle radio-labelled Investigational Products? Yes

- Investigational Product: Extemporaneous Preparation
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes

- Record Archiving: Yes
- EMR/EHR systems: Other
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: CRO ( Clinical Research Organisation), Sponsor

- 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