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@veracityclinicalresearch.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:
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
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
- HREC Committee Name: Other
- Meeting frequency: Twice a month
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Sponsor Provided Central
- Mandate distribution of safety: No
- Meeting frequency: Twice a month
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Sponsor Provided Central
- Mandate distribution of safety: No
Facility staffing and training
- Handling Investigational Product: Yes
- Training program for the research staff: No
- Include GCP: Yes
- Facility written sop during transportation to satellite site: N/A
- Training program for the research staff: No
- 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: : No
- 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: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving: Yes
- EMR/EHR systems: Yes
- Has your Clinical Trial Site or Service been accredited? Not Applicable
- Audit Type: FDA
- EMR/EHR systems: Yes
- Has your Clinical Trial Site or Service been accredited? Not Applicable
- Audit Type: FDA
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): Yes
- 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): No
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): Yes
- 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
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
Does your Facility 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
Geriatrics 65 and onwards