Details
- Organisation Name: Veracity Clinical Research Pty Ltd
- HHS: N/A
- Services Offered by your site: Clinical trials site, Investigator Initiated Trials
- Contact person email address: trials@veracityclincialresearch.com.au
- Website address:www.veracityclinicalresearch.com.au
- Affiliated Research Sites or Satellite Sites/Clinics?: N/A
Location
Enter the name of the Clinical Trial Site- Organisation Name: Veracity Clinical Research Pty Ltd., GPS location of your Clinical Trial Site- GPS Location 1: , GPS location of your Clinical Trial Site- GPS Location 2:
Initiating study activities approval
Is your Facility able to initiate study activities prior to HREC (IRB/ERB/ETHICS) Committee protocol approval?: Yes
Review required
How long prior to HREC meeting does the application need to be submitted?: 1 week
Site Overview
Please provide the short promotional description of your Clinical Trial Site for marketing purposes.: Veracity Clinical Research is a dermatology clinical research company that conducts clinical research trials in the field of inflammatory skin conditions. Lead by Dermatologist - Dr Lynda Spelman, Veracity Clinical Research is a dedicated private research facility with experienced investigators and study coordinators. Dr Spelman has over 30 years experience in clinical trials having participated in over 210 clinical research studies.
HREC
What types of HREC (IRB/ERB/ETHICS) Committee does your Facility use? Select all that apply. If QH choose Central Acting as Local-For National Mutual Acceptance (NMA): Sponsor Provided Central, Does your institution and/or local regulation mandate the distribution of safety reports e.g., Development Safety Update Report (DSUR), Suspected Unexpected Serious Adverse Reaction (SUSAR) to a local review only HREC (IRB/ERB/ETHICS) Committee?: No, If Other was selected for the HREC Committee Name, please name here.: , What is the meeting frequency of your Local HREC Committee?: Twice a Month
Facility staffing and training
Does your Facility have a training program for the research staff?: No, Does the course content include GCP?: Yes, Does the study staff that prepares or transports dangerous goods have training that meets the IATA International Air Transport Association (US) or other countries hazardous training requirements for shipping dangerous goods?: Yes, Is your Facility adequately staffed to support studies with both blinded and unblinded Investigational Product?: Yes
Licenses to receive, store, dispense and return controlled substances
Does the Facility have the required licenses or registrations to receive, store, dispense and return controlled substances as required by local law?: No, Does the Facility have the ability to handle radio-labelled Investigational Products?: No
Equipment
Do you have centrifuge available at the Facility to support Research studies?: Yes, Do you have refrigerated centrifuge available at the Facility to support Research studies?: Yes, Identify the Investigational Product Storage Equipment at your Facility | Freezer (-20 to -30 Degrees C): Yes, Please identify the Investigational Product preparation capabilities at your Facility:
Patient Records
Does your Facility have patient record archiving on-site?: Yes, Do you have Electronic Health Records (EHR)/ Electronic Medical Records (EMR)?: Yes
Investigational product storage Capabilities
Do you have a refrigerator (2 to 8 Degrees C) available at the Facility to support Research studies?: Yes, Refrigerator 2 to 8 Degrees C | Do you have the ability to generate a temperature monitoring log for this equipment?: Yes, Refrigerator 2 to 8 Degrees C | Does this equipment provide Min/Max Temperature Monitoring?: Yes, Refrigerator 2 to 8 Degrees C | Does this equipment have back-up power?: No, Refrigerator 2 to 8 Degrees C | Does this equipment have a temperature alarm?: Yes, Refrigerator 2 to 8 Degrees C | Do you have an SOP that supports the calibration of this equipment?: Yes, Do you have a freezer (-20 to -30 Degrees C) available at the Facility to support Research studies?: Yes, Do you have a freezer (-70 to -80 Degrees C) available at the Facility to support Research studies?: Yes, Do you have a freezer (-Liquid Nitrogen -135 Degrees C) available at the Facility to support Research studies?: Yes
Specialty Research Area
Occupational Diseases
Pathological Conditions
Signs and Symptoms
Skin and Connective Tissue Diseases
Wounds and Injuries
Study Types
Academic
Industry
Investigator
Source Document Types
Paper
Average time to start study (in calendar days)
30-60
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
Support in-patient admissions
No
PK & PD specimens
Yes
Study Phase Capability
Device Pilot
Device Pivotal
Device Post Approval
Phase I
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
ECG/EKG Electrocardiogram
MRI Magnetic Resonance Imaging
X-Ray
Patient Population
Adolescents/Adults 16 and onwards
Adults 18 and onwards
Geriatrics 65 and onwards