Clinical Research Department (CRD) is located within the Coffs Harbour GP SuperClinic, hence we have access to a large variety of innovative and new facilities.
These include a separate room for monitoring, computers for electronic data, analogue line for transmission of study data, electronic data base for source documentation compliant with FDA section CFR21, a statistical e-program to assist with patient pre-screening, a separate room for emergency cases equipped with resuscitation machine, IV perfusion, blood collection point, ECG, a refrigerator dedicated to storing study medication, immunisation monitor for the refrigerator dedicated to vaccines, a minus 20 Celsius freezer with daily temperature monitoring & double locked study medication storage.
In addition, the department has access to a wide range of services and specialists located inside the clinic like chiropractor, dietitian, physiologist, physiotherapist, podiatrist, psychologist, mental health nurse and social worker.
Outside the clinic the department can easily access services like medical imaging such as MRI, X-Ray, Ultrasound, CT Scan, Nuclear Medicine and Bone Densitometry, Day Procedure Unit, Pharmacy, Sleep centre.
CRD utilizes the services of Bellberry Limited as a Human Research Ethics Committee (HREC).
Standard Operating Procedures have been implemented to ensure the harmonisation and streamline of the study conduct.
Motivation and commitment
CRD is committed to provide professional services following the principles of Good Clinical Practice (GCP) and internally constituted Standard Operating Procedures (SOPs).
Clinical Research Investigators undergo GCP training based on our own constituted training manual.
Standard Operating Procedures (SOPs) based on applicable regulations establish the standards for conduct of clinical research at CRD.
Generic source documents created for every study are a tool used as a standard for collecting patient data.
- Induction manual for new staff members
- GCP Training Manual and mentoring by a senior staff member
- Staff Training File
- Regular study meeting updates and training
- General guide for study start-up, conduct and closure.
Patient source data management
CRD has a fully networked computer system with dedicated server and high speed internet access. The patient data system is compliant with FDA CRF21 regulations and enables a secured recording and archiving of the study data.
A dedicated computer shall be available for the sponsor company monitors for e-CRF monitoring.
Data recording training and experience:
- Medidata RAVE
- RDC Oracle
- RDC- Trial Manager
Due to the extensive experience of our site staff, Clinical Research Department can succesfully conduct studies covering a wide range of therapeutic areas in primary care:
- Mental Health
Well organised and efficient set-up including:
- Computerised database of > 14, 000 patients;
- Five satellite sites;
- Trained site staff;
- Streamlined Human Research Ethics Committee (HREC) Submission
- Streamlined Contract and budget negotiation
- Central Management
Our structure and facilities enable us to ensure high data quality through efficiency, consistency and high standards of service.
During the feasibility visit the sponsors will have the opportunity to:
- meet our motivated team and have a tour of the facilities
- receive pre-screening estimates of eligible subjects and our enrollment potential;
- discuss our streamlined process and quick set-up
- collect start-up documents and sites staff CVs and training records