From first-in-human to US and Europe pivotal
The split. bioaccess® runs first-in-human medical device trials in Latin America. RQM+ keeps the US and Europe pivotal. bioaccess® is the preferred FIH partner. RQM+ is the preferred US/EU pivotal partner for the next stage.
Most US medtech sponsors treat first-in-human as the whole plan. It is not. FIH answers whether the device can be used in people and whether the early safety and performance signals hold. The pivotal answers whether that evidence is large enough, controlled enough, and local enough for US or European market authorization.
Those are different jobs. We stopped pretending one CRO should own both.
Who does what
bioaccess® owns FIH. We are the First-in-Human CRO, founded in 2010 and headquartered in Miami. We run first-in-human and early feasibility medical device trials in Latin America. In our experience since 2010, those programs start in 6–8 weeks and run roughly 40% faster and about 30% lower per-patient cost than typical US/EU programs. Those figures are experience-based estimates, not a formal study.
US regulatory strategy stays anchored in Miami: Pre-Sub, IDE, and the 21 CFR 812.28 file that lets FDA review foreign device data. When a US site is the right first step, our sister site Amavita Research in Miami can enroll cardiovascular patients on US soil. That US site is not replaced by this partnership.
RQM+ owns the US and Europe pivotal that follows. Site network, monitoring volume, IDE or EU clinical-investigation scale, and the statistical plan a PMA, De Novo, or CE-mark pivotal has to carry. RQM+ is The MedTech CRO (rqmplus.com). That is their work. It is not ours.
We do not hand you a PDF and disappear. We stay on the FIH file. RQM+ picks up the pivotal file. The sponsor stays the sponsor.
Who this is for
This split is for a US-based medtech sponsor that needs first-in-human data now and already knows a US or Europe pivotal is the next raise or the next FDA meeting.
It is for a Class III cardiovascular device, or any high-risk implant, where FIH should be small, fast, and clean — and the pivotal should be large, controlled, and inspectable.
It is not for a sponsor that wants one CRO to keep every stage forever. That model is slow and expensive at FIH, and thin at pivotal scale.
FAQ: do we hand you off?
No. A handoff is not a dump.
When the FIH database is locked, or earlier if the FDA Pre-Sub says the next study is a US/EU pivotal, bioaccess® introduces RQM+ with the protocol, the monitoring file, the device history, the ethics-committee correspondence, and the 21 CFR 812.28 narrative already written. You stay on both calls. You decide the statement of work.
If you came to RQM+ first and you still need FIH in Latin America, the reverse is the same: RQM+ is the preferred US/EU pivotal partner; bioaccess® is the preferred FIH partner.
Eligibility of foreign clinical data for FDA review does not predict clearance or approval of any application. 21 CFR 812.28 sets the conditions under which FDA will look at the file. It does not decide the file.
Talk to us
Talk to bioaccess® about first-in-human. Talk to RQM+ about the US or Europe pivotal that follows.