General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.
Signs you are behind
- The registered primary completion date has passed and the study still shows recruiting.
- Sites have been added mid-study.
- Screen-failure rates are higher than the protocol assumed.
For the underlying math, see catchment math for Australian recruitment.
A same-protocol second country
See adding a Latin American country to an Australia-only NCT, and our bioaccess® vs Australia comparison for the R&D tax incentive question.
Standards and U.S. data acceptance
The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia, the Caucasus or Latin America.
How Latin America compares
- Same FDA rule: 21 CFR 812.28.
- Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
- Time zone: 0–2 hours from U.S. Eastern.
- U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
- Trade-offs: Spanish or Portuguese documents and investigational import permits.
More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Georgia · Armenia · Clinical Accelerator comparison · Vantage Clinical comparison
Frequently asked questions
Can I add a Latin American country to an Australian FIH?
Yes, a second country can run under the same protocol with its own ethics and regulatory approvals.
Will FDA accept the combined data?
Foreign data can support FDA submissions under 21 CFR 812.28, case by case.
Next step
Weighing Central Asia or the Caucasus against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerator podcast to talk through your FIH plan.