For sponsors

Facility and equipment

Vitalis is an ambulatory clinical trial site. All visits, including dosing and extended observation, are conducted on a day-stay basis, with observation supported for up to 14 hours per visit day. The inventory below sets out the clinical spaces, equipment, staffing and competencies held on site.

Dosing bays: 12
Monitoring rooms: 6
Consulting rooms: 4
Max observation: 14 hours

01 / Spaces

Clinical spaces

Dedicated trial space, separate from any routine clinical activity conducted on the premises. Figures shown in teal are drafted from the confirmed room counts and should be checked against the floor plan.

Dosing bays: 12 dedicated dosing bays in a single supervised area, each with direct line of sight from the central staff station. Resuscitation trolley positioned within 8 metres of every bay, with a dedicated dosing preparation bench and a separate pre-dose checking station.
Individual monitoring rooms: 6 single-occupancy monitoring rooms, each fitted with a reclining chair, call bell, and a bedside monitor slaved to the central display. Used for protocols requiring privacy, isolation, or uninterrupted continuous monitoring.
Consulting rooms: 4 Principal Investigator and Sub-Investigator consulting rooms, used for specialist review, physical examination, eligibility assessment and study visits.
Physician consulting rooms: 6 further consulting rooms used by the specialist panel and referring physicians.
Observation capacity: Up to 18 participants under simultaneous observation across the dosing bays and monitoring rooms, for a maximum of 14 hours per visit day. Meals are provided under protocol-controlled conditions where required.
Infusion positions: 6 infusion positions within the dosing area, with volumetric pumps, syringe drivers and a dedicated infusion preparation bench.
Screening and consent rooms: 3 private rooms used for informed consent discussions and screening assessments, acoustically separated from clinical areas so that consent can be taken without interruption.
Investigational product pharmacy: Access-controlled room with temperature-monitored ambient, refrigerated and frozen storage, a segregated quarantine and returns area, and a dedicated preparation bench.
Participant amenities: Day lounge, wifi, refreshment facilities, accessible bathrooms, lockers, and a waiting area separate from any general practice waiting room.
Records storage: Access-controlled area for essential documents and source records, with lockable fire-rated cabinets and restricted key access, and long-term archiving for the retention period required by regulation and by the sponsor's agreement.
Operating hours: 06:00 – 22:00 Monday to Friday, with weekend and extended-hours visits scheduled where the protocol requires them.

02 / Staffing

Staffing

The permanent site team. Cohort size and visit scheduling are set against the staff rostered for each visit day.

Research nurse

Study coordinators

Sleep technologists

Trial pharmacist

Cohort sizing: Cohort size is set by the clinical staff rostered for the visit day rather than by the number of bays. Additional cannulation-trained staff are rostered for sentinel dosing and for protocols with intensive early sampling.
Quality and data: 1 quality manager and 2 data entry staff, independent of the study teams.
Specialist Advisory Panel: Six practising specialists — intensive care and critical care, anaesthesia, cardiology, endocrinology and oncology — advising on protocol feasibility, study design and participant safety. The panel →

03 / Equipment

Equipment held on site

Held at the unit, calibrated and maintained under standard operating procedure, and operated by staff trained and assessed for each device.

✓

12-lead ECGResting, serial and triplicate acquisition at protocol-defined timepoints, with digital export for central over-read.

✓

Holter monitoringAmbulatory ECG recording, with recording and analysis performed on site.

✓

Sleep apnoea testingIn-laboratory polysomnography and unattended home studies.

✓

MSLT and MWTMultiple Sleep Latency Test and Maintenance of Wakefulness Test, conducted to standard protocol.

Imaging and any assessment not held on site is arranged with established providers in the St Kilda Road and Alfred precinct, scheduled around the participant's visit rather than as a separate journey.

04 / Samples

Phlebotomy and sample management

Dense pharmacokinetic sampling schedules across 12 dosing bays are supported by trained phlebotomy staff and on-site processing.

Phlebotomy competency: All clinical staff performing venepuncture are phlebotomy-trained, with competency assessed on appointment and reassessed annually against the training matrix. Three staff are additionally trained and assessed in peripheral cannulation for serial sampling.
Serial and timed sampling: Cannula-based sampling to protocol-defined timepoints. Clocks across the dosing area are synchronised to a single source, actual sampling times are recorded to the minute, and timepoint deviations are logged and reported rather than rounded.
Centrifugation: 4 refrigerated centrifuges with programmable speed, temperature and duration, calibration records held, and capacity to process 12 participants in parallel within a 30-minute post-collection window.
Frozen and cold storage: 3 × −80 °C freezers, 2 × −20 °C freezers and 4 × 2–8 °C refrigerators, dedicated to trial samples and investigational product and physically separated from any non-trial storage.
Temperature monitoring: Continuous monitoring on every unit with probe readings logged at 5-minute intervals and automated out-of-hours alarm escalation to named site staff on a documented roster. Excursions are logged, assessed and reported to the sponsor before affected material is used.
Backup power and contingency: Uninterruptible power supply on all freezers and monitoring equipment, with a documented emergency transfer plan to an offsite −80 °C facility.
Dry ice and shipping: Standing dry ice supply arrangement with next-day replenishment, IATA-trained staff for dangerous goods packing, labelling and documentation, and courier dispatch to central laboratories on protocol-defined schedules.
Chain of custody: Sample accountability logs maintained from collection through processing, storage and dispatch, with barcode labelling and reconciliation against the central laboratory manifest on receipt confirmation.
Local pathology: Safety laboratory samples processed by Australian Clinical Labs (ACL), whose Specialised Trials division supports clinical trial sample handling, with 24-hour turnaround for screening and safety results, and same-day results available where eligibility depends on them.

05 / Product

Investigational product handling

Receipt and storage: Access-controlled pharmacy with temperature-monitored ambient, refrigerated and frozen storage, segregated quarantine and returns areas, and receipt reconciliation performed on the day of delivery.
Controlled substances: Schedule 8 drug safe with bound register and dual-signature reconciliation. Held under a permit issued by the Victorian Department of Health under the Drugs, Poisons and Controlled Substances Act 1981 (Vic).
Preparation and dispensing: Dedicated trial pharmacist, with non-sterile preparation performed on site and aseptic preparation arranged externally.
Cold chain: Validated receipt procedures with temperature-logger review on arrival, documented excursion escalation to the sponsor before use, and qualified shippers for onward transfer.
Accountability: Accountability logs maintained per participant and per shipment, reconciled at every monitoring visit and at close-out, with documented return or on-site destruction.
Randomisation and blinding: IWRS and IVRS access, blinded and unblinded staff roles documented in the delegation log, and an emergency unblinding procedure available at all hours with a code break log maintained under SOP.

06 / Competency

Staff competencies

Competency is assessed, dated and recorded against the training matrix. No task is delegated without a recorded competency.

Phlebotomy and cannulation

All clinical staff phlebotomy-trained with assessed competency reviewed annually; three staff additionally trained in peripheral cannulation for serial pharmacokinetic sampling.

ECG acquisition

Clinical staff are trained in standardised 12-lead electrode placement, serial and triplicate acquisition, and digital transmission to central over-read providers.

Sleep technology

3 RPSGT-credentialled sleep technologists, scoring to current AASM criteria, with inter-scorer reliability reviewed annually.

Resuscitation

Basic Life Support is current for all clinical staff, and two staff hold current Advanced Life Support certification.

Good Clinical Practice

ICH E6(R3) GCP training refreshed every two years for all staff performing trial-related duties, with role-specific training in consent, safety reporting and product handling.

Dangerous goods

Two IATA-trained staff for packing, labelling and documenting biological sample shipments, with certification renewed on the required two-year cycle.

Immunisation and injection

Nurse immunisers authorised to administer vaccines and injections under Victorian authority, with post-vaccination observation and anaphylaxis management training current.

Specialist input

The Specialist Advisory Panel reviews protocols in the relevant discipline. Panel member CVs, registration details and GCP records are provided at feasibility.

07 / Emergency

Emergency preparedness and escalation

Resuscitation equipment: 2 resuscitation trolleys — one in the dosing area, one serving the monitoring rooms — each with defibrillator, airway management equipment, suction and emergency drug supply, checked and documented daily.
Oxygen and suction: Portable oxygen cylinders held on site, with suction available in the dosing and monitoring areas.
Medical cover: A medically qualified investigator or delegate is present on site throughout dosing and the full 14-hour observation period, with 24-hour on-call medical availability for participants for the duration of their participation.
Nearest emergency department: The Alfred, 55 Commercial Road, Melbourne — a major trauma centre in the same postcode as the site, approximately 1.5 km and 5 minutes by road.
Transfer arrangement: Documented escalation and ambulance transfer procedure to The Alfred, with the receiving department notified of the study and the investigational product involved.
Anaphylaxis and reaction management: Documented procedure and stocked emergency medication at every dosing bay, with staff trained in administration and in the observation requirements following vaccination or injection.
Business continuity: Documented procedures for power failure, equipment failure, freezer excursion, loss of premises access and infectious disease restrictions, reviewed annually.

08 / Calibration

Equipment calibration and records

Calibration register: All measuring equipment held on a calibration register with scheduled external calibration, certificates retained, and each item traceable to the visits on which it was used.
Daily verification: Scales and thermometer checks, centrifuge parameter confirmation and defibrillator checks recorded on each day of use.
Preventive maintenance: Scheduled by manufacturer interval, service records retained, and defective equipment quarantined, labelled and removed from the delegation of use until returned to service.
Computerised systems: Systems used for trial data are access-controlled with individual user accounts, role-based permissions and audit trails, and are validated for their intended use before a study begins.

09 / Location

Location and access

Address

456 St Kilda Road
Melbourne, Victoria 3004, Australia

Parking is available on site. The building provides disability access for people with mobility needs. Tram services run the length of St Kilda Road with stops close to the building, and the site is a short distance from the Alfred precinct.

Sponsor visits

Melbourne Airport (Tullamarine) is approximately 40 minutes by road; Avalon Airport serves some domestic routes. Site visits and video walkthroughs can be arranged prior to contract execution, and monitoring visits are accommodated with 5 business days' notice.

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