Last checked 1 October 2026. General information, not legal or regulatory advice. bioaccess® is not affiliated with QPS Holdings, LLC or QPS. Their names are used here only to identify their firm. Statements about QPS are taken from the public materials 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.
QPS Holdings is a global contract research organization centered on early-phase drug development: owned Phase I clinical pharmacology units totaling 550+ beds (per its published early-phase brochure), integrated bioanalytical laboratories, and an approximately 1,200-person organization. Its first-in-human work is drug and biologic clinical pharmacology — healthy-volunteer SAD/MAD, bioavailability, and DDI studies. It is a credible choice for sponsors that need bed capacity for a drug FIH program. bioaccess® is the alternative when the asset is a medical device (or radiopharma or biopharma asset) whose FIH must be designed against a target FDA submission — IDE, 510(k), De Novo, PMA, HDE, IND — and executed where the economics and timelines favor a startup: FDA strategy and Pre-Sub planning from Miami, execution across 19 Latin American countries (or a real Miami cardiovascular site where the device and study fit), backed by a 12-month protocol-to-LPLV written guarantee.
| Metric | bioaccess® | QPS |
|---|---|---|
| Focus | FIH-only CRO for MedTech, Biopharma & Radiopharma startups — device-led FIH designed against the target FDA submission | Global early-phase CRO — drug and biologic clinical pharmacology; device FIH/EFS is not a marketed specialty |
| FIH model | Physician-led first-in-patient device studies under ISO 14155, designed for IDE-path FDA submissions | Bed-count Phase I units: healthy-volunteer SAD/MAD, bioavailability, DDI — the drug-development FIH model |
| Owned clinical capacity | Amavita Research: a real Miami cardiovascular clinical site where the device and study fit; 50+ pre-qualified LATAM sites | 550+ Phase I beds across six owned units on three continents (per published early-phase brochure), including 95 beds in South Miami |
| Latin American FIH execution | U.S. + 19 Latin American countries, 50+ pre-qualified sites, in-house ethics/import/monitoring | QPS lists Argentina, Brazil, and Chile on its network map; its public materials describe network/partner presence — no owned Phase I units or marketed LATAM FIH trial execution found |
| 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: strong IND clinical-pharmacology execution; no marketed FDA Early Feasibility Study (device) practice found |
| 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: unit-based Phase I pricing; written milestone guarantees are uncommon in the CRO market |
| Typical per-patient cost | $15K–$35K (LATAM FIH) | $40K–$75K in US/EU benchmark ranges for unit-based Phase I work |
| Best-fit sponsor profile | Seed-to-Series-B MedTech, Biopharma & Radiopharma startups running their first device-led FIH study | Sponsors needing owned Phase I bed capacity for drug/biologic FIH — SAD/MAD, bioavailability, DDI, TQT |
The QPS figures in the competitor column are taken from QPS's publicly published early-phase materials (brochure and Australia flyer, sources below) and are presented as the publisher's claims; headcount and bed counts are approximate and change over time. bioaccess®'s figures are its own published benchmarks, not quotes. Confirm current terms with each provider.
QPS is a serious early-phase organization: 550+ Phase I beds across six owned units on three continents, integrated bioanalytical laboratories, and an approximately 1,200-person team built for drug-development clinical pharmacology. If your first-in-human program is a small molecule or biologic that needs healthy-volunteer SAD/MAD, bioavailability, or DDI work, that bed capacity is exactly what you want. bioaccess® does not compete for that work.
The comparison starts where the asset is a medical device. A device FIH is not a bed-count problem — it is an IDE-path problem: physician-led first-in-patient studies under ISO 14155, designed from day one against the target FDA submission (IDE, 510(k), De Novo, PMA, HDE, IND). That is bioaccess®'s entire business: FDA EFS strategy and Pre-Sub planning from Miami, execution across 19 Latin American countries (or Amavita Research, a real Miami cardiovascular site, where the device and study fit), and a 12-month protocol-to-LPLV written guarantee with a fee-credit clause.
On Latin America specifically, the honest note: QPS lists Argentina, Brazil, and Chile on its network map, but its public materials describe network or partner presence there — we found no owned Phase I units and no marketed LATAM FIH trial execution. bioaccess®'s LATAM footprint is the operating core of the business: 50+ pre-qualified sites, in-house ethics, import/export, and monitoring across 19 countries, with data eligible for FDA submission and review under 21 CFR 812.28 (devices) or ICH E6 (drugs and biologics) — a case-by-case regulatory determination, not a guarantee of clearance or approval.
Only in a narrow slice. QPS is a large, reputable organization serving a broad customer base across many programs. 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, QPS 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 QPS (or a similar global CRO) 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.
You can run drug clinical-pharmacology work there — that is what the unit is built for. A medical-device first-in-human study is a different discipline: physician-led first-in-patient enrollment under ISO 14155, designed against an IDE-path FDA submission. QPS does not market a device EFS/FIH practice. If your asset is a drug or biologic needing bed capacity, QPS's Miami unit is a credible option; if it is a device needing an FDA-bridgeable FIH dataset, bioaccess® is purpose-built for it.
QPS lists Argentina, Brazil, and Chile on its network map, but its public materials describe network or partner presence — we found no owned Phase I units and no marketed LATAM first-in-human trial execution. bioaccess®'s Latin American footprint is its operating core: 50+ pre-qualified sites across 19 countries with in-house ethics, import/export, and monitoring, designed from day one for FDA submission eligibility under 21 CFR 812.28.
A drug first-in-human study is typically a healthy-volunteer clinical-pharmacology program — single and multiple ascending dose (SAD/MAD), bioavailability, drug-drug interaction — run in owned Phase I bed units under an IND. A device first-in-human study is typically a physician-led first-in-patient study run under ISO 14155 and, in the U.S., an IDE (including the FDA Early Feasibility Study program). Different regulations, different sites, different operational expertise — which is why bed count is not the right way to choose a device FIH partner.
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