Clinical trial site · Melbourne, Victoria, Australia
A multi-specialty clinical trial site in Australia
Vitalis Clinical Research conducts Phase I to Phase IV clinical trials for Australian and international sponsors. Studies are supported by a Specialist Advisory Panel of practising clinicians and conducted on an ambulatory day-stay basis across dedicated dosing, monitoring and consulting facilities.
- Phases conducted
- I – IV
- Advisory panel
- 6 specialists
- Therapeutic areas
- All outpatient
- Dosing bays
- 12
- Individual monitoring rooms
- 6
- Maximum observation period
- 14 hours
- Government R&D incentives
- Among the world's best
- HREC submission → approval
- ~4–6 weeks
Australia
Conducting clinical trials in Australia
Three factors commonly cited by sponsors when selecting an Australian trial site.
R&D
Access to leading R&D incentives
Australia offers some of the world's most competitive government support for clinical research. Eligible companies may receive a refundable cash benefit on qualifying trial expenditure, which is material to the overall cost position of an Australian programme.
CTN
Notification, not application
Under the CTN scheme the trial is approved by a Human Research Ethics Committee and authorised by the institution; the TGA is notified rather than asked. There is no regulator review cycle sitting between you and first dose.
ICH GCP
Internationally accepted data
Trials conducted in Australia to ICH E6(R3) Good Clinical Practice are routinely accepted by the FDA, the EMA and other regulatory authorities in support of subsequent submissions.
Start-up
From synopsis to green light
Indicative durations. Contracting and budget negotiation proceed in parallel with ethics review wherever possible.
Feasibility
On receipt of a protocol synopsis, the site provides a recruitment estimate against the inclusion and exclusion criteria, a proposed visit-day capacity and staffing plan across the 12 dosing bays and 6 monitoring rooms, and any protocol clarifications required prior to ethics submission.
Budget and contract
Per-participant costing prepared from the schedule of assessments. The clinical trial research agreement is negotiated and executed in parallel with the ethics submission.
HREC submission and review
Submission to Bellberry Limited or to the St Vincent's Hospital Melbourne Human Research Ethics Committee, depending on the study, comprising the protocol, Investigator's Brochure, participant information and consent form, and proposed recruitment material. Most committees meet monthly and issue a single round of queries.
CTN notification and site authorisation
Following ethics approval, the sponsor submits the notification to the TGA and the approving authority authorises the trial at this site. The notification is an administrative step and does not involve scientific review.
Site initiation and green light
Site initiation visit, delegation log, investigational product receipt and accountability, pharmacy set-up, EDC and laboratory kit readiness, and protocol-specific training recorded against the training matrix.
Capability
Trials conducted at the site
Phase I to Phase IV, across the therapeutic areas covered by the specialist panel.
I
Phase I
Day-stay studies with up to 14 hours of on-site observation across 12 dosing bays and 6 individual monitoring rooms: single-dose pharmacokinetics, food effect, drug–drug interaction, bioavailability and bioequivalence, and cardiac safety assessment. Protocols requiring overnight residential confinement are not conducted at this site.
II
Phase II
Proof-of-concept and dose-ranging studies in patient populations, led by the relevant specialist investigator and supported by the site's referral networks.
III
Phase III
Multi-centre confirmatory trials, including long-duration and blinded comparator designs, with outpatient clinic capacity and dedicated study coordinators.
IV
Phase IV
Post-marketing studies, registries, observational and real-world evidence programmes conducted alongside routine specialist practice.
Specialists
Specialist Advisory Panel
Practising clinicians who advise the site on protocol feasibility, study design and participant safety within their own disciplines. The Principal Investigator for each study is appointed to that protocol and supported by the site's research nursing and coordination team.
Dr Mainak Majumdar
Specialist Intensivist
A/Prof Michael Keane
Specialist Anaesthetist
Dr Jodie-Ann Senior
Specialist Cardiologist
Dr Chin-Yau Tan
Specialist Endocrinologist
Dr Sem Liew
Specialist Oncologist
Dr Arul Sivanesan
Critical Care Doctor
Panel member CVs, GCP training records and prior trial experience are provided to sponsors at feasibility. More about the panel →
For participants
Considering taking part in a study?
Some studies recruit healthy volunteers and others recruit people living with a particular condition. You will be given full written information about what is involved before you are asked to consent, and you may withdraw at any time without giving a reason.
Next step
Request a site feasibility assessment
A written feasibility assessment covering recruitment capability against your inclusion and exclusion criteria, an indicative start-up timeline, a budget estimate and the site profile.