For sponsors
Capabilities and population access
Trial phases conducted, the therapeutic areas covered by the specialist panel, populations accessible to the site, and services provided to sponsors.
- Phases
- I – IV
- Advisory panel
- 6
- Dosing bays
- 12
01 / Designs
Study types by phase
Grouped by the demands each phase places on the site.
Phase I — day stay
Single-dose pharmacokinetic studies, food effect, drug–drug interaction, absolute bioavailability, cardiac-safety designs and bioequivalence, conducted with extended on-site observation of up to 14 hours. Protocols requiring overnight residential confinement are not conducted at this site and are identified as out of scope at feasibility.
Phase I — return visit
Studies with sparse sampling and scheduled return visits, vaccine immunogenicity and reactogenicity studies, and extended follow-up designs where retention over months rather than dosing intensity is the principal demand.
Phase II — patient cohorts
Phase 1b and Phase 2a studies across all therapeutic areas that can be managed on an outpatient basis, with protocol review by the Specialist Advisory Panel in the relevant discipline. Participants are identified through the panel's own practices and referring clinicians, supplemented by ethics-approved advertising.
Phase III and IV
Multi-centre confirmatory trials, long-duration and blinded comparator designs, post-marketing studies, registries and observational programmes. Conducted through the outpatient trial clinics alongside the specialist's routine practice, with dedicated study coordinators assigned to each protocol.
Study selection
The site declines protocols it cannot staff safely for the acuity involved, studies requiring facilities not available on site, and studies where the site's recruitment estimate would not support the sponsor's timeline. Any such limitation is identified in writing at feasibility.
02 / Recruitment
Recruitment
Sources of participants, catchment, and the assumptions used in the site's recruitment estimates.
- Registered participant database
- A database of people who have consented to be contacted about studies, held under the Australian Privacy Principles and the Health Records Act 2001 (Vic), with documented consent and an opt-out mechanism.
- Specialist referral networks
- Patients identified through the Specialist Advisory Panel's own practices and through referring clinicians across metropolitan Melbourne.
- Catchment
- Greater Melbourne and surrounding regions — a resident population of approximately 5.3 million, with around 2 million people within 45 minutes' travel of the site.
- Screen-to-enrol ratios
- Ratios drawn from the site's own screening records are applied to every recruitment estimate provided at feasibility, rather than assuming that everyone screened will enrol.
- Screening throughput
- Screening visits are scheduled without displacing an active dosing cohort, using the consulting and screening rooms rather than the dosing area.
- Advertising
- All participant-facing recruitment material is HREC-approved before use, version-controlled, and reported against for reach and conversion.
- Retention
- Reimbursement paid on a published schedule, appointment reminders before each visit, and transport assistance where the protocol requires early-morning attendance.
03 / Delivery
Services to sponsors
The site operates within the sponsor's or CRO's systems and does not require the adoption of its own.
EDC agnostic
Staff trained on the sponsor's or CRO's chosen EDC. Source documentation maintained to support the data entered, with a documented source-data location list.
Sample handling
On-site processing, centrifugation, aliquoting and storage at −80 °C, −20 °C and 2–8 °C, with continuous temperature monitoring and out-of-hours alarm escalation. Courier dispatch to central laboratories on protocol-defined schedules.
Pharmacy
Investigational product receipt, storage, accountability and destruction under SOP, managed by a dedicated trial pharmacist in an access-controlled pharmacy.
Monitoring
Three dedicated monitoring workstations, remote monitoring access where the sponsor's systems allow it, and query turnaround inside five business days.
Safety reporting
SAE identification, assessment and reporting to the sponsor and HREC inside required timelines, with 24-hour investigator availability during dosing and observation periods.
Documentation
Essential documents maintained to ICH E6(R3) in an inspection-ready trial master file, with a documented filing plan and periodic quality checks.
Request a feasibility assessment
Written recruitment, timeline and budget assessment against your protocol.