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FOR SPONSORS
Sponsor FAQ
Quick answers to the questions sponsors and CROs ask most when evaluating CTI as a site for their next study.
For a full deep-dive on our capabilities, infrastructure, and trial journey, see Our Capabilities. For specific questions not covered here, get in touch.
Getting started
What is your typical CDA turnaround time?
CTI's typical CDA turnaround is 3-7 business days. We accept electronic signatures via Dropbox Sign, or wet-ink where specifically required. Expedited review can be accommodated when aligned with study timelines.
Who is our primary contact at CTI?
For most sponsor and CRO communications, your primary contact is our Operations team, who can be reached at manager@clinicaltrialsinstitute.com.au. Or for feasabilities our contact is feasibilities@clinicaltrialsinstitute.com.au. Our Operations team coordinates a dedicated feasibility and start-up process that handles CDA, feasibility, contracts, ethics, governance, and SIV, giving you a single front door from first contact through to first patient.
How does the feasibility process work?
After CDA execution, our Operations Team coordinates the feasibility assessment with our Trial coordinators and Investigators. We review your protocol synopsis against our patient database, infrastructure, equipment, and team capacity, and respond with honest, evidence-based feedback before either side commits further.
Capabilities & experience
What phases of trials does CTI support?
CTI supports Phase 1b through Phase 4 trials, including industry-sponsored interventional studies, registry trials, and patient experience studies. Our infrastructure, team, and SOPs are configured to ICH-GCP E6 (R3) standards.
What therapeutic areas does CTI cover?
Our focus areas include endocrinology and metabolic (diabetes, obesity, gout, thyroid disorders), vaccines (COVID-19, RSV, influenza, pneumococcal, HPV), respiratory (COVID-19, asthma, COPD), mental health, pain management, women's health, sports medicine, cardiovascular, and diagnostic studies. If your therapeutic area isn't listed, get in touch as our team has experience across a broader range than this suggests.
What experience does your team have?
Our trial support team brings over 60 years of combined clinical research experience, with collective involvement in 80+ studies across multiple therapeutic areas. We maintain documented training records and Investigator CVs available on request, updated every 2 years or sooner if significant changes occur.
How do you recruit participants?
CTI uses a multi-channel recruitment approach: our internal participant database of 350,000+ individuals, a strong GP referral network across our Torquay main site and two satellite locations, and targeted social media outreach. All recruitment is conducted in accordance with ethics requirements and privacy protections.
Compliance & quality
What accreditations and certifications do CTI hold?
All CTI staff hold current ICH-GCP E6 (R3) certification, and CTI staff involved in sample shipping are IATA Dangerous Goods accredited. On-site partners include Melbourne Pathology (NATA-accredited) and Vision Radiology (DIAS-accredited). Our SOPs align with current ICH-GCP standards, and CVs and training records are available on request.
What ethics and governance pathways do you use?
CTI's preferred independent ethics committee is Bellberry, with an average HREC turnaround of 20 days. Internal governance review is typically completed within 24-48 hours. Ethics and governance pathways run in parallel where possible to minimise time from contract execution to site activation. CTI can also act as a lead HREC site on a study-by-study basis.
What is your approach to quality and audit readiness?
CTI's SOPs align with ICH-GCP E6 (R3) standards and are updated regularly. Investigator CVs are refreshed every 2 years, training records are maintained centrally, and AHPRA registrations are stored in our central document system. Source documentation can be paper, eMR, or sponsor-provided electronic platforms. Document archiving is provided for 15 years (or per sponsor/HREC requirement). Sponsor audits and regulatory inspections are welcomed with advance notice.
Operations & logistics
What is the contract and budget timeline?
First contract review typically takes 10-15 business days. We work with the Medicines Australia standard CTRA templates and indemnities. Our standard payment terms are NET 30, and we accept flexible invoicing including monthly, milestone-based, activation-based, or Recipient Created Tax Invoices (RCTI). Our site fee schedule is available on request.
What is your IP and sample handling capability?
We have temperature-controlled IP storage across three ranges: 2–8°C, ≤–20°C, and ≤–80°C, plus secure ambient storage, all monitored continuously with Wi-Fi temperature loggers and excursion management SOPs. Our sample processing area includes a refrigerated centrifuge, laboratory incubator, and dedicated lab bench space.
How does site initiation work?
Site Initiation Visits are coordinated by our Administration team with at least 2–3 weeks' notice. We support both on-site SIVs (preferred for IMP handling, devices, and pharmacy onboarding) and virtual SIVs for low-risk studies. The Principal Investigator attends a minimum 30–60 minutes of the SIV, with the Study Coordinators joining the full session. Pharmacy initiation can be joint with the main SIV or scheduled separately. Our site contains a dedicated board room space with video conferencing facilities for dial in and presentation.
What is your monitoring visit availability?
Monitoring visits should be booked at least 2–4 weeks in advance. Standard monitoring hours are 9am–5pm Monday to Friday, with weekend or extended hours by negotiation. Remote monitoring is fully supported, with no additional fees for standard activities. We provide a private monitoring room, high-speed Wi-Fi, and printer access.
Where is CTI located, and do you have multiple sites?
Our sites are located between 60-90 minutes from Melbourne, in close proximity to international and domestic airports, and close to public transport, with free on-site parking available. Our main site is at 101/1 Cylinders Drive, in the scenic coastal town of Torquay, VIC 3228, with satellite locations at Myers Street Family Medical Practice (Geelong 3220) and The Cottage Medical Centre (Grovedale 3216). Together, these three sites give us access to a population catchment of approximately 300,000 across the Surf Coast and Greater Geelong region. CTI Torquay is the primary trial facility with on-site partners across pathology, radiology, and pharmacy.
Still have questions?
Get in touch with our Operations Team. Or if you have a feasibility, send it through.