If you typed Precision for Medicine (New Zealand) into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what Precision publishes (Precision for Medicine: New Zealand Clinical Trial Landscape (21 Nov 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 Precision publishes
Precision for Medicine says New Zealand runs “about 20-25% of Australia’s” trial load and “can start even faster than Australia, including in First-In Human (FIH) studies”. It cites 4–6 weeks from ethics submission to trial start, no IND, and 30–50% lower costs than the U.S. or Europe. It also lists Medsafe “approval time of 45 days”. Medsafe’s current guideline gives a target of 32 working days for drug trial applications, and device trials don’t need Medsafe approval at all. The article names New Zealand early-phase sites but doesn’t describe Precision’s own device first-in-human studies there.
Precision vs bioaccess®
| Dimension | Precision | bioaccess® |
|---|---|---|
| Core focus | Global CRO, oncology and precision-medicine led | First-in-human and early feasibility studies for medical devices |
| Geography | Global, including Australia and New Zealand | Latin America, since 2010 |
| Device FIH track record | Not covered in the New Zealand article | 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
For biomarker-heavy oncology or early-phase drug programs spanning Australia and New Zealand, Precision’s model makes sense.
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 Precision, 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 Precision. 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
How long does Medsafe take to approve a trial?
For new medicines, Medsafe’s guideline targets an outcome within 32 working days of receiving the application, once fees are paid. Medical device trials need HDEC ethics approval but no Medsafe approval.
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 Precision?
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 Precision public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.