If you typed Aotearoa Clinical Trials (ACTT) into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what ACTT publishes (aotearoatrials.nz/sponsors, ACTT Annual Report 2025) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.
What ACTT publishes
ACTT calls itself “New Zealand’s largest public-hospital-based clinical research site network”. It claims Phase I–IV capability “from early first-in-human studies through to post-marketing research”, centralised feasibility review, IAOCR Gold accreditation, and status as an IRD-approved Research Provider for New Zealand’s R&D Tax Incentive. Its 2025 Annual Report says it partners with “biopharmaceutical and medical device companies from around the world”. It also notes that after “a challenging 2024, trial activation numbers have rebounded”, and it reports a new hospital-based Phase I overnight facility at Middlemore. We found no named device first-in-human study on the public pages we reviewed.
ACTT vs bioaccess®
| Dimension | ACTT | bioaccess® |
|---|---|---|
| Core focus | Public-hospital site network, Phase I–IV | First-in-human and early feasibility studies for medical devices |
| Geography | New Zealand (Counties Manukau, Northland and network hospitals) | Latin America, since 2010 |
| Device FIH track record | Says it partners with device companies; no named device FIH found | Published case studies on bioaccessla.com |
| After the trial | See provider site | Multi-country sanitary registration and in-country holder service |
Where each one fits
If you want New Zealand public-hospital investigators and a single network contract, and your enrollment target fits New Zealand’s population, ACTT fits well. Its approved-provider status also matters if you have a New Zealand entity claiming the R&D Tax Incentive.
If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including ACTT, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.
New Zealand offers real country advantages:
– device trials need HDEC ethics approval but no Medsafe approval;
– one ethics review covers all sites;
– HDEC aims to decide within 15 days (expedited review) or 35 days (full review).
Those advantages belong to the country, not to ACTT. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.
Frequently asked questions
Can ACTT help me claim New Zealand’s R&D Tax Incentive?
ACTT says it is an IRD-approved Research Provider. Eligibility depends on your own New Zealand tax position. Inland Revenue sets the rules.
Does a device trial in New Zealand need Medsafe approval?
No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).
Can Latin American device data support an FDA submission?
Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.
When is bioaccess® the better choice than ACTT?
When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.
Ready to compare a proposal? Request a first-in-human study proposal.
Competitor facts come from the ACTT public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.