Details
- Organisation Name: Holdsworth House Medical Brisbane
- HHS: N/A
- Services Offered: Clinical trials site, Treatment of patients
- Website Address: https://research.holdsworthhouse.com.au
- Contact: research@holdsworthhouse.com.au
- Other Affiliated Research Sites: Holdsworth House Medical Practice Sydney
Location
-27.4582583,153.036689,17
Initiating study activities approval
No
Review required
2 weeks
Site Overview
Holdsworth House Clinical Research has a long history of conducting studies in HIV and infectious diseases, and more recently have expanded our therapeutic areas to include cardiovascular disease, immunology and general medicine. Our Clinical Research team take pride in their high recruitment and retention rates and strive for optimal patient care and high quality standards at all times.
HREC
- HREC Committee Name: Belberry HREC
- Meeting frequency: Twice a Month
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local
- Mandate distribution of safety: Yes
- Meeting frequency: Twice a Month
- 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? No
- Does the Facility have the ability to handle radio-labelled Investigational Products? No
Equipment
- Investigational Product:
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving: Yes
- EMR/EHR systems: In-house system
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: CRO ( Clinical Research Organisation), Sponsor
- EMR/EHR systems: In-house system
- 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
Bacterial Infections and Mycoses
Cardiovascular
Cardiovascular Diseases
Female Urogenital Diseases and Pregnancy Complications
HIV
HIV Screening
HIV – AIDS
Immune System Diseases
Infectious Diseases
Male Urogenital Diseases
Study Types
Industry
Source Document Types
Paper and Electronic
Has your Clinical Trials Site or Service been audited by:
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
Does the HREC committee require contract /budget approval prior to release final approval documents?
Yes
Support in-patient admissions
Not Applicable
PK & PD specimens
Yes
Study Phase Capability
Phase III
Type of Diagnostic Equipment
DXA Dual-Energy X-ray Absorptiometry or Bone Densitometry
ECG/EKG Electrocardiogram
Patient Population
Geriatrics 65 and onwards
Adults 18 and onwards