Details
- Organisation Name: Wesley Research Institute
- HHS: N/A
- Services Offered: Early Phase, Complementary medicines clinical trials, Clinical trials site, Investigator Initiated Trials
- Website Address: www.wesleyresearch.org.au
- Contact: Ann Tremellen- anne.tremellen@wesleyresearch.org.au
- Other Affiliated Research Sites: Wesley sites
Location
-27.476994016067582, 152.9977111539699
Initiating study activities approval
No
Review required
2 weeks
Site Overview
The Clinical Trials Centre at Wesley Medical Research focuses on giving hope and changing lives by enabling patient participation in national and international phase I-IV clinical trials with a focus on evaluating new therapies, drugs, and diagnostic tools to drive discoveries into standard clinical practice. Engaged across four hospitals - The Wesley Hospital, St Andrew's War Memorial Hospital, Buderim Private Hospital, and St Stephen's (Hervey Bay) - clinicians and patients located in both metropolitan and regional areas can participate.
Our patients are at the heart of all we do and that is why Wesley Medical Research focuses on providing participants, researchers, and sponsors with a first-class, professional experience. Our dedicated staff strives for a reputation of integrity and quality, delivering a warm, caring and inviting environment for all participants.
Other areas of expertise include Gastroenterology, Neuroscience, Rare Diseases populations.
Sub-Therapeutic areas include Gastroenterology - Coeliac Disease, IBD, IBS Neuroscience - Parkinson's Disease, Multiple Sclerosis, Motor Neuron Disease, Tourette's Syndrome Rare Diseases Populations - Immune Disorders, Ataxia-telangiectasis (AT), WHIM Syndrome, Pompe Disease, Porphyria disease.
Our patients are at the heart of all we do and that is why Wesley Medical Research focuses on providing participants, researchers, and sponsors with a first-class, professional experience. Our dedicated staff strives for a reputation of integrity and quality, delivering a warm, caring and inviting environment for all participants.
Other areas of expertise include Gastroenterology, Neuroscience, Rare Diseases populations.
Sub-Therapeutic areas include Gastroenterology - Coeliac Disease, IBD, IBS Neuroscience - Parkinson's Disease, Multiple Sclerosis, Motor Neuron Disease, Tourette's Syndrome Rare Diseases Populations - Immune Disorders, Ataxia-telangiectasis (AT), WHIM Syndrome, Pompe Disease, Porphyria disease.
HREC
- HREC Committee Name: UnitingCare Health
- Meeting frequency: Other
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Central Acting as Local, Sponsor Provided Central
- Mandate distribution of safety: Yes
- Meeting frequency: Other
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Central Acting as Local, Sponsor Provided Central
- 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: Vertical laminar flow hood (chemo/hazardous drugs), 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? Not Applicable
- Audit Type: Sponsor
- EMR/EHR systems: In-house
- Has your Clinical Trial Site or Service been accredited? Not Applicable
- Audit Type: 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 Diseases
Congenital
Digestive System Diseases
Endocrine System Diseases
Gastroenterology
General Medicine
Hereditary and Neonatal Diseases and Abnormalities
Immune System Diseases
Male Urogenital Diseases
Mental Disorders
Musculoskeletal Diseases
Nervous System Diseases
Neuroscience
Nutritional and Metabolic Diseases
Otorhinolaryngologic Diseases
Parasitic Diseases
Respiratory Tract Diseases
Skin and Connective Tissue Diseases
Virus Diseases
Study Types
Academic
Government
Industry
Investigator
Source Document Types
Paper and Electronic
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?
No
Support in-patient admissions
Yes
PK & PD specimens
Yes
Study Phase Capability
Phase I
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
FLRO Fluoroscopy
MAMMO Mammography
MRI Magnetic Resonance Imaging
NMED Nuclear medicine e.g. Bone scan
PET Positron Emission Tomography Scan
X-Ray
Patient Population
Paediatrics
Adolescents/Adults 16 and onwards
Adults 18 and onwards
Geriatrics 65 and onwards