Last checked 30 September 2026. General information, not legal or regulatory advice. bioaccess® is not affiliated with MMC Medical, MMC Medical International Consulting Services, or Laura Minarsch. Their names are used here only to identify their firm. Statements about MMC Medical are taken from the public case study and podcast listed under the comparison table (sources below) and are presented as the publisher's claims. Offers and facts change, so confirm current terms with each provider.
MMC Medical International Consulting Services is a specialized first-in-human medical-device CRO founded in 1992 by Laura Minarsch. A published case study reports 70+ device studies completed since 2019, 15–18 studies managed concurrently, and operations described across four continents; its much-cited 'five hours' figure refers to electronic data capture (EDC) study builds, not whole clinical trials. MMC is a capable, long-tenured choice for rapid early-stage device studies. bioaccess® is the geography-neutral alternative: we assess whether your program belongs in a U.S. Early Feasibility Study or a Latin American first-in-human — and tell you honestly which one it needs — then anchor the study to FDA strategy (Pre-Sub, IDE planning) from Miami, execute across 19 Latin American countries (or a Miami cardiovascular site where the device and study fit), and back the timeline with a 12-month protocol-to-LPLV written guarantee. Julio G. Martinez-Clark interviewed Laura Minarsch on the Global Trial Accelerators™ podcast (Season 2, Episode 4, October 2019); bioaccess® respects MMC Medical's record in this space.
| Metric | bioaccess® | MMC Medical |
|---|---|---|
| Focus | FIH-only CRO for MedTech, Biopharma & Radiopharma startups — geography-neutral U.S.-EFS-vs-LATAM assessment | Specialized first-in-human medical-device CRO — rapid early-stage device studies, reportedly 70+ completed since 2019 |
| Founder / tenure | Founded 2010 by two interventional cardiologists (one Harvard-trained); headquartered in Miami | Reportedly founded 1992 by Laura Minarsch; evolved from interventional-cardiology specialists |
| Operating model / speed | FIH-12™: typically 4–8 months protocol → first patient; ~10-patient FIH $300K–$500K; 12-month protocol-to-LPLV written guarantee | Reportedly builds EDC studies in as fast as five hours (Castor EDC platform — study setup, not the clinical study) and manages 15–18 concurrent studies; public claims describe rapid execution for short-duration device trials |
| Geography | U.S. + 19 Latin American countries, 50+ pre-qualified sites | Described as operating across four continents; their public materials cite Europe, Canada, South America, New Zealand, and Australia |
| U.S. regulatory anchoring | FDA EFS strategy and Pre-Submission/execution planning from Miami; the FIH is designed against the target U.S. submission (IDE, 510(k), De Novo, PMA, HDE, IND) | Category-level: varies; their public positioning centers on rapid execution and strategic clinical affairs for early-stage devices |
| U.S. site option | Amavita Research: a real Miami cardiovascular clinical site where the device and study fit | Category-level: no public Miami site claim; CRO consulting/operations model |
| Pricing model | Fixed-price with 12-month risk-sharing guarantee — if we miss the protocol-to-LPLV timeline for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV | Category-level: written milestone guarantees are uncommon in the CRO market |
| Regulatory standard for devices | ISO 14155 + Declaration of Helsinki; data eligible for FDA submission/review under 21 CFR 812.28 | ISO 14155-aligned; category-standard for medical-device trials |
| Best-fit sponsor profile | Seed-to-Series-B MedTech, Biopharma & Radiopharma startups that want an honest U.S.-EFS-vs-LATAM-FIH recommendation before committing | Sponsors that have settled on a device FIH geography and want a long-tenured rapid-execution specialist |
The MMC figures in the competitor column are quoted from a publicly published case study and are labeled 'reportedly' — they are MMC's public claims, not bioaccess®'s verification. bioaccess®'s figures are its own published benchmarks, not quotes. Offers and facts change, so confirm current terms with each provider.
MMC Medical is a genuine category pioneer: a first-in-human device CRO reportedly founded in 1992 by Laura Minarsch, with 70+ device studies completed since 2019 and 15–18 studies managed concurrently. We interviewed Laura on our podcast in 2019 and respect what that team has built. bioaccess® is the alternative when the country question is still open — not a second version of the same shop, but a geography-neutral FIH CRO that tells you honestly whether your program belongs in a U.S. Early Feasibility Study or in Latin America.
That geography-neutral assessment is the core difference. bioaccess® anchors every program to U.S. FDA strategy from Miami — Pre-Submission planning, IDE planning, and a data package built for 21 CFR 812.28 — then executes across 19 Latin American countries (or a real Miami cardiovascular site, Amavita Research, where the device and study fit). The FIH-12™ engagement backs it with a 12-month protocol-to-LPLV written guarantee with a fee-credit clause if we miss that timeline for reasons within our control.
Data is generated under ISO 14155 and the Declaration of Helsinki and is eligible for FDA submission and review under 21 CFR 812.28 (for devices) or ICH E6 for drugs and biologics — a case-by-case regulatory determination, not a guarantee of clearance or approval. If your geography is settled and you want a rapid-execution specialist, MMC Medical is a credible choice; if you're choosing between the U.S. and Latin America, bioaccess® exists precisely to give you the honest answer.
Only in a narrow slice. MMC Medical is a capable, reputable CRO. bioaccess® is purpose-built for a single job: first-in-human clinical trials for MedTech, Biopharma and Radiopharma startups, executed across the U.S. and Latin America. If your program is a global pivotal or a post-market study, MMC Medical is often a better fit. If your program is your first-in-human trial and you need clean, FDA-bridgeable data on a startup budget and timeline, bioaccess® is purpose-built for it.
Clinical data from studies conducted outside the U.S. under ISO 14155 and the Declaration of Helsinki is eligible for FDA submission and review under 21 CFR 812.28 (for devices) and comparable ICH E6 pathways for drugs and biologics. Acceptance is a case-by-case regulatory determination, not a guarantee of clearance or approval — our regulatory team designs the study with the target FDA submission (IDE, 510(k), De Novo, PMA, HDE, IND) as the anchor.
A ~10-patient FIH study through FIH-12™ runs $300K–$500K, with a 12-month protocol-to-LPLV written guarantee and first patient typically 4–8 months after protocol. Per-patient cost is $15K–$35K vs. $40K–$75K in US/EU benchmark ranges. Ethics approval is 4–8 weeks in Latin American jurisdictions vs. 6–12 months in the US/EU.
Yes — sponsors regularly do. A common pattern is to run FIH with bioaccess® in Latin America to generate clean, regulator-ready data fast, then hand off to MMC Medical (or another CRO suited to that later-phase work) for a multi-region pivotal, registration, or post-market program. Our regulatory strategy is designed to be portable so that data and documentation transfer cleanly to any downstream CRO.
It refers to electronic data capture (EDC) study builds — configuring the study database in Castor's EDC platform — not running a clinical study. The case study credits reusable templates and field-characteristic imports for compressing study setup from months to as fast as five hours. A first-in-human device study itself still takes months to enroll, treat, and follow patients; no CRO runs a whole clinical trial in five hours.
It depends on what's decided. If your geography is settled and you want a long-tenured rapid-execution FIH device specialist, MMC Medical's three-decade record is a credible fit. If the geography is part of the strategy — U.S. Early Feasibility Study or Latin American first-in-human — bioaccess® gives you the honest assessment first, then FDA-anchored strategy from Miami, multi-country LATAM execution, a Miami cardiovascular site option where the study fits, and a 12-month protocol-to-LPLV written guarantee.
Yes. Julio G. Martinez-Clark interviewed Laura Minarsch — founder and President of MMC Medical International Services — on the Global Trial Accelerators™ podcast in October 2019 (Season 2, Episode 4). The conversation covered strategically planned first-in-human submissions and studies across Europe, Canada, South America, New Zealand, and Australia. bioaccess® respects MMC Medical's record in this space; this page exists to help sponsors choose the right FIH partner for their specific program.
Yes — sponsors regularly do. A common pattern is to use MMC Medical for strategic clinical-affairs support in geographies outside bioaccess®'s LATAM footprint, and bioaccess® for the Latin American first-in-human execution with U.S. FDA strategy anchoring the program. Our regulatory strategy is designed to be portable so documentation transfers cleanly between partners.
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