Your questions, answered.

If you’ve completed your prototype, generated pre-clinical data based on a robust risk analysis plan, and defined your intended use, you’re likely ready to explore a first-in-human or feasibility study. We can assess your device, documentation, and regulatory pathway to confirm readiness and define the next steps.

Australia offers globally recognised ICH-GCP/ISO 14155-compliant standards, rapid ethics and regulatory approvals, and generous R&D tax incentives—up to 43% cashback on eligible spend. Data collected here are widely accepted by international regulatory authorities, making it the ideal place to start.

Budgets vary by study size, endpoints, and number of sites. Early feasibility studies with full-service typically range from AUD $250K–$1M; pivotal studies are higher. We tailor budgets to your design and help identify tax and funding offsets.

Running early feasibility or safety studies in Australia allows you to collect high-quality data quickly, which can be used in your FDA IDE or 510(k) submission. This “ANZ-to-US bridge” is one of the most time-efficient routes to market.

Medical device trials focus on performance and safety, not drug pharmacokinetics. They’re usually smaller, faster, and more iterative—requiring deep technical and engineering understanding as well as clinical rigour. Focus is on safety and feasibility of the application or procedure, technical training and user experience whereas in drug trials, controlled exposure for safety and efficacy are paramount.

We’re ISO 9001-certified and can fully align with your SOPs or integrate our own. Our eTMF, CTMS, and QMS are audit-ready and inspection-compliant, ensuring seamless collaboration with sponsor systems.

Yes. Australian and New Zealand trials follow ICH-GCP/ISO 14155, accepted by the FDA and EMA. Data generated here routinely supports IDE, PMA, and CE Mark submissions.

Initial ethics approval can be achieved in as little as 6-12 weeks, with site contracts and approvals around 4 weeks. Regulatory notifications (medical devices) is same day. Site start-up is typically faster than in the US or EU given the regulatory notification only pathway for most device studies. Pharma studies in NZ require regulatory approval which can run in parallel to other reviews.

We work with validated systems and our in-house built EDC uses Dacima platforms and hosting. Our in-house data management and biostatistics team ensures compliant setup, real-time data review, and clean, analysis-ready datasets. All EDC and DM staff are Australian-based, ensuring eligibility for Australia R+D tax incentive programs.

Our team follows ISO 14155 and ICH GCP requirements with ongoing audit trails, SAE reconciliation, and continuous training. Inspection readiness is embedded from day one—every file, every form, every visit.

If you have a working prototype and supportive bench or pre-clinical data, you’re ready to discuss clinical validation. We’ll review your device, risk class, and regulatory pathway to determine the best starting point.

We manage everything from early feasibility studies to pivotal and post-market trials across Australia, New Zealand, and the US. We can provide support for other countries, too, through our network of strategic partners.

Fast ethics approvals, ICH-GCP/ISO 14155 compliance, and access to experienced investigators make ANZ an ideal region for early-phase work. Data are globally recognised and eligible for R&D rebates.

With established investigator networks and streamlined ethics processes, we typically activate sites within 8–16 weeks from final protocol sign-off (depending on the site type/location).

We manage amendments pragmatically—assessing regulatory implications, updating documentation, retraining sites, and maintaining compliance so the study stays on track.

End-to-end management: site selection, contracting, monitoring, data management, and reporting. We coordinate every operational detail to ensure smooth delivery.

We leverage long-standing investigator relationships across ANZ and the US. Sites are chosen for relevant experience, patient access, and reliability—and we stay closely involved throughout.

All studies follow ISO 14155 and ICH GCP. Continuous monitoring, database checks, and real-time query resolution ensure complete, reliable datasets.

You’ll have a single project manager as your point of contact, backed by our Senior Management and specialist consultants as needed. We maintain transparent reporting and regular cadence calls for full oversight.

Yes. We’ve delivered decentralised and hybrid studies using digital recruitment, telehealth follow-ups, and remote monitoring—all within regulatory frameworks.

Yes, have a look at our case studies and ask us for more if none seem relevant to your project!

Absolutely. We assist with PMCF/PMCF studies, safety reporting, and ongoing clinical evaluation to maintain compliance after launch.

Yes. Through our partner network we help define reimbursement strategies, code mapping, and health economics analysis to support commercial rollout.

We prepare final clinical investigation reports and can assist with regulatory submissions, technical file compilation, and planning for pivotal or post-market phases.

Yes. Our network includes experts in product development, manufacturing, regulatory strategy, pre-clinical testing, and commercialisation—ensuring continuity from lab to market.