Gallipoli Medical Research Foundation is an Approved Research Institute (ARI) committed to enhancing the health of the Australian community through the highest quality medical research.

Our dedicated Clinical Trials Unit delivers high quality results for studies of emerging new medications and better tolerated therapies for the benefit of our participants and the wider community.

Research to Restore Lives

GALLIPOLI MEDICAL RESEARCH FOUNDATION

Clinical Trials Unit

Our strength is our peopleThe Clinical Trials Unit of the Gallipoli Medical Research Foundation is proud to be based within the campus of Greenslopes Private Hospital (GPH), the largest private teaching hospital in Australia.

In addition to the benefits of the strong history of research in the hospital, our location provides us with access to a large population of Consultants and Visiting Medical Officers based in GPH on long-term contracts.

In 2014, our Clinical Trials Unit was awarded ‘Best Site 2014’ by ARCS Australia. We are grateful to our colleagues in the therapeutics industry who granted us this honour due to our: “Excellent facilities with highly trained, dedicated staff and proactive support of sponsor activities”.

StaffOur Clinical Trials Unit is purpose built with a team of dedicated staff.

With combined experience of over 50 years in a broad range of therapeutic areas, our team emphasises the importance of teamwork in providing the highest quality trial conduct. The team is composed of four Clinical Trial Coordinators (including two Senior Coordinators), Data Manager, Ethics & Compliance Officer, and Clinical Trials Assistant. Our highly responsive staff work

“My patients really benefit from the support they receive from the team at GMRF”.Dr Victoria Atkinson (Principal Investigator, Oncology)

Clinical Trials Unit Research to Restore Lives

together to deliver on promises. The day to day oversight of the unit is managed by Miriam Dwyer (GMRF CEO), who has over 20 years of experience working in drug development.

We have staff proficient in performing: ECGs, blood collection and processing (including IATA Dangerous Goods Shipper certification), and vital signs measurements. Our team use a range of electronic Case Report Forms such as InForm, Medidata Rave and many others. We focus on rigorous and continuous training of CTU staff. All staff members (including Investigators) undergo training in good clinical practice every two years.

InvestigatorsMany of our Investigators are key opinion leaders in their respective fields. These clinical specialists work in partnership with the GMRF team to ensure protocol compliance, ensure participant safety and guarantee accurate research data.

All Investigators are proactive and dedicated to fulfilling their responsibilities in the clinical trials coordinated by GMRF. We facilitate and coordinate both sponsored and investigator initiated trials for the Greenslopes Private Hospital (GPH) medical community.

“This is the best team I have ever worked with in my many years of doing trials!”-Prof Darrell Crawford (GMRF Director of Research, Principal Investigator in Hepatology and Head of the School of Medicine, University of Queensland).

Clinical Trials Unit Research to Restore Lives

CollaboratorsBased at Greenslopes Private Hospital (GPH), we have a strong working relationship with the hospital community. We work very closely with the staff at the Cyril Gilbert Cancer Centre on our oncology and haematology studies and with the GPH Liver Clinic for our hepatitis trials. We also have a close working relationship with the third party service providers such as Ramsay Pharmacy, APHS Pharmacy, Sullivan Nicolaides Pathology, Queensland X-Ray, and Lung Function Facilities of GPH. In addition, we have a list of preferred providers proficient in clinical trial reporting requirements for dermatology and ophthalmology examinations.

ParticipantsPotential participants are referred to our Unit by the Principal Investigators and Co-Investigators as well as external doctors and other hospitals. In addition GMRF will advertise for clinical trial participants if necessary.

We regularly collaborate with patient advocacy groups to contribute to their understanding of clinical trials and promote access to clinical trials. Our website lists the trials currently open to recruitment and our Site is also listed on the Australian Clinical Trials website.

We have an excellent record of meeting - and often exceeding - recruitment targets

In 2014 we were the highest recruiting Site in Australia for the CA209-066 metastatic melanoma study. We have been the first Site to receive ethics approval for numerous HCV studies and have also been the highest recruiting Site in Australia for many of those studies.

“We all work together for our patients and for the Sponsors

– that is why we succeed”.Dr Katherine Stuart (Principal Investigator, Hepatology).

Our Advantage Leading through specialisation

Therapeutic areasSome clinical trial centres specialise in one therapeutic area. At GMRF, we have the expertise and facilities to conduct trials in a wide range of areas. We also collaborate with a variety of highly engaged investigators and have access to the knowledge of academic research streams within GMRF.

Our CTU has extensive experience in the following indications:

• Hepatology, primarily hepatitis C

• Oncology including metastatic melanoma, pancreatic cancer, and ovarian cancer

• Respiratory including non-CF bronchiectasis, COPD, and pulmonary fibrosis

• Hematology including chronic lymphocytic leukaemia, lymphoma and myelodysplastic syndromes

• Ophthalmology including retinopathy and macular degeneration

Study feasibilityContract preparations happen in parallel with ethics approval.

The feasibility of any potential study is thoroughly assessed in order to ensure that the protocol is clinically relevant which is clinically relevant, in addition to confirming that sufficient resources are available and recruitment targets are attainable.

GMRF uses the Greenslopes Research and Ethics Committee (GREC) for all trial submissions and a separate governance submission is not required. Our dedicated Ethics Coordinator/Compliance Officer, Ms April Josephsen, supports Investigators to prepare human research ethics proposals and manages the ongoing administration of trials from an ethics coordination and compliance perspective for our Site.

Clinical Trials Unit Research to Restore Lives

With a clinical background as a Registered Nurse, April has been involved in Phase I–IV Sponsored, Collaborative Group and Investigator Initiated Research for more than 14 years. She has been personally responsible for the preparation and submission of greater than 100 initial submission applications to date. April is also responsible for the preparation and submission of Protocol Amendments, Site specific Participant Information Sheet and Informed Consent Forms (PISICFs), regulatory, safety and other administrative activities.

Governance occurs informally and in parallel to the Ethics submission process at our Site, further enhancing our Site’s capacity to deliver optimal metrics targeting without compromise of standards and/or applicable regulatory obligations.

Study start-upOur current timeframe from initial submission to study start-up is approximately 1 month.

Our highly efficient start-up processes ensure quick turnaround times for all studies. Our staff can streamline this process through access to the efficient and responsive ethics committee in Greenslopes Private Hospital.

We were the first Site in Australia to receive HREC Approval for seven of our active studies in Q1/2 of 2014.

Compliance We maintain audit ready status at all times.

In addition to operating in full compliance with ICH-GCP and the TGA guidelines on Good Clinical Practice, GMRF Clinical Trials Unit operates under a complete set of internal Standard Operating Procedures.

Regular internal audits ensure study protocol and SOP compliance and ensure the integrity of the data presented to our Sponsors.

Facilities We offer the following facilities and equipment within studies:

• Temperature monitored -20°C and -80°C freezers

• Refrigerated centrifuge

• ECG machine

• Vital signs machines

• Spirometer

• EDTRS eye chart

• Two dedicated consultant rooms for participants visits

• Dedicated room for trial monitors

• Secure swipe access facility to ensure confidentiality and security of clinical trial records

• Offsite archiving

All equipment is calibrated and maintained and records are available for inspection at any time.

Our Unit also has access to facilities performing:

• CT scan including RECIST reporting

• MRI

• Ultrasound

• Lung function tests

• Ophthalmology assessments

• Dermatological assessments

• Cardiac monitoring such as ECHO

Ramsay Pharmacy and APHS Pharmacy facilities allow dedicated medication storage for our clinical trials including: temperature monitoring, dispensation and destruction as required.

Clinical Trials Unit Research to Restore Lives

CONTACT US

Address

Gallipoli Medical Research Foundation

Greenslopes Private Hospital

Newdegate Street

GREENSLOPES QLD 4120

Phone: (07) 3394 7284

Fax: (07) 3394 7767

Email: ClinicalTrials.GMRF@ramsayhealth.com.au