Momentum Clinical Research vs a Latin America First-in-Human Device CRO (bioaccess®)

Momentum Clinical Research (formerly P3 Research) vs bioaccess®: what Australasia’s 19-site network publishes, where it fits, and when a Latin America device FIH specialist fits better.

If you typed Momentum Clinical Research into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what Momentum publishes (momentumclinicalresearch.co.nz (p3research.co.nz now redirects there)) 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 Momentum publishes

Momentum calls itself “Australasia’s largest clinical trial network”. It reports 19 clinical research sites across Australia and New Zealand “streamlined under one centralised system”, more than two decades of Phase I–IV experience across most therapeutic areas, and 118 active studies. The former P3 Research website now redirects to Momentum. We found no named medical-device first-in-human study on its public pages.

Momentum vs bioaccess®

Dimension Momentum bioaccess®
Core focus Phase I–IV site network, mainly drug studies First-in-human and early feasibility studies for medical devices
Geography Australia and New Zealand (19 sites) Latin America, since 2010
Device FIH track record None named on the public pages we reviewed 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 your drug trial needs many trans-Tasman sites under one contract and one system, Momentum is built for that.

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 Momentum, 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 Momentum. 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

Is Momentum the same as P3 Research?

The p3research.co.nz web address now redirects to Momentum Clinical Research’s New Zealand site. For corporate details, check Momentum directly.

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 Momentum?

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 Momentum public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.

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