Vitalis
About Vitalis
The site, the specialist panel, and the way trials are conducted here.
Vitalis Clinical Research is a multi-specialty clinical trial site in Melbourne, Victoria. The site conducts Phase I to Phase IV trials for Australian and international sponsors on an ambulatory day-stay basis, supported by a permanent research operations team and a Specialist Advisory Panel of practising clinicians across intensive care and critical care, anaesthesia, cardiology, endocrinology and oncology.
The site was established to give sponsors a single Melbourne location capable of running trials across the full range of outpatient therapeutic areas, rather than one confined to a narrow specialty. Twelve dosing bays, six individual monitoring rooms and observation for up to fourteen hours allow protocols with dense sampling and long observation periods to be conducted without an overnight admission.
Its position on St Kilda Road places it within the Alfred precinct — a few minutes from a major trauma centre, on a tram corridor, and close to the specialist practices from which many participants are referred.
The team
Specialist Advisory Panel
Practising clinicians who advise the site within their own disciplines on protocol feasibility, study design and participant safety. Panel member CVs, registration details and GCP records are provided to sponsors at feasibility.
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
The Principal Investigator and Sub-Investigators for each study are appointed to that protocol. Panel member CVs, registration details and GCP training records are provided to sponsors at feasibility.
Site team
Research operations
The permanent team that runs studies day to day.
A/Prof Rex Prabhu
Medical Director
Medical Administration and Clinical Governance
Clinical Operations
Study coordinators assigned to each protocol for its duration, responsible for scheduling, source documentation, monitoring visits and query resolution.
Research Nursing
Research nurses covering screening, consent support, dosing, observation, phlebotomy and cannulation, with competency assessed and recorded against the training matrix.
Quality
A quality function independent of the study teams, responsible for the SOP framework, training records, deviation and CAPA management and internal audit.
Pharmacy
Investigational product receipt, storage, accountability, dispensing and destruction under SOP, in an access-controlled pharmacy with temperature-monitored storage.
Recruitment
Management of the participant database, ethics-approved advertising, screening throughput and retention across the life of each study.
How we work
Our approach
Realistic feasibility
Recruitment estimates are based on the site's own historical screening data and are provided in writing, together with any limitation that would prevent the site from meeting the sponsor's timeline.
Specialist input
Protocols are reviewed by the Specialist Advisory Panel in the relevant discipline before the site accepts them, and studies are supported by research nurses and coordinators assigned to the protocol for its duration.
Transparent quality management
Protocol deviations are logged, assessed and reported to the sponsor and, where required, to the HREC, with corrective and preventive actions tracked to closure.