Last checked 28 September 2026. General information, not legal or regulatory advice. bioaccess® is not affiliated with Try The Trial, TryTheTrial OÜ, Tigermed, or Vantage. "Try The Trial" and its package names belong to their owners and are used here only to identify their offer. Every statement about Try The Trial is taken from its public website as listed on 28 September 2026 (sources under the comparison table). Offers change, so confirm current terms with each provider.
Try The Trial, operated by TryTheTrial OÜ in Estonia and described on its site as a product of Tigermed EMEA (Europe, Middle East and Africa), lists five standardized first-in-human (FIH) and proof-of-concept packages at $545,000 to $795,000 (as listed on 28 September 2026). Each runs in one country selected by Tigermed EMEA, with a listed study start-up (SSU) of 6–7 months and an overall timeline that "depends on the protocol." Its one device package is for non-implantable devices. bioaccess® has been the first-in-human contract research organization (CRO) for medical devices in Latin America since 2010. For a U.S. device sponsor, bioaccess® is the stronger fit when you want to choose the country, take an implant into humans, get the protocol-to-last-patient-last-visit (LPLV) timeline in writing under FIH-12™, our 12-month FIH timeline guarantee, keep the study in same or adjacent U.S. time zones, or add U.S. patients in Miami.
| Metric | bioaccess® | Try The Trial |
|---|---|---|
| Focus | First-in-human (FIH) and early feasibility studies (EFS) for medical devices in Latin America; FIH-only focus since 2010 | Standardized FIH and proof-of-concept packages across drugs, biologics, cardiovascular, neuro, oncology, and devices (products & pricing page) |
| Device scope | Implants included. Public examples: the Axoft neural implant and the Newrotex SilkAxons™ nerve guide in Panama, and the Avantec Vascular Sangria™ venous system in El Salvador (case studies) | MedTech Velocity: "Standardized early-phase trial for medical devices (non-implantable)," 15–20 subjects. Other programs get a custom fixed price "within the price points above" (products & pricing page) |
| Country | Sponsor-matched from our lead FIH jurisdictions (Panama, El Salvador, Chile, and the Dominican Republic) plus Brazil. Multi-country when needed | "ONE COUNTRY ONLY, at Tigermed EMEA selection." The country is not named on its public pages; the FAQ calls it a "Regulatory Bridge" country |
| Distance from the U.S. team | Same or adjacent U.S. time zones, with regulatory strategy run from Miami in Eastern Time | Not stated; depends on the country selected (products & pricing page, FAQ) |
| U.S. patients | Sister site Amavita Research Services in Miami, a cardiovascular clinical trial site certified to GCSA, the clinical research site quality standard of the International Accrediting Organization for Clinical Research (IAOCR) | "Tier-1 Geo Unlock" upgrade for the U.S. or Western Europe. No price listed (FAQ) |
| Listed price | Priced per protocol in a written proposal. Published benchmarks: $300,000–$500,000 in CRO fees for a 10-patient FIH study, and $15,000–$35,000 per patient in Latin America (costs and timelines page) | $545,000 (MedTech Velocity) to $795,000 (Onco Discovery); Pharma Genesis and Cardio Sprint $645,000; Neuro Synapse $695,000, as listed on 28 September 2026 (products & pricing page) |
| Start-up | Ethics-committee approval in a median of 4–8 weeks in Latin America | "SSU: 6-7 months" on every package card (SSU = study start-up) |
| Timeline commitment | FIH-12™, our 12-month FIH timeline guarantee: we put your protocol-to-LPLV timeline in writing. If we miss it for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV. Full terms in your proposal | "Timeline: Depends on the protocol." The FAQ says the overall timeline and deliverables are agreed with each sponsor |
| What the engagement includes | FIH-12™ offer stack: U.S. Regulatory Anchor Plan, FIH protocol and ISO 14155 compliance architecture, in-country ethics and regulatory submissions, pre-qualified site activation, an enrollment and retention program, and the 812.28-Ready Data Room | Included: feasibility, regulatory start-up, site contracting, project management, site monitoring, data management and statistics, investigator site fees. Excluded: medical writing, systems, laboratory and clinical services ("variable cost"), third-party vendors, patient travel ("billed at cost"), insurance ("variable cost") |
| Protocol writing | FIH protocol authoring and ISO 14155 (the international good clinical practice standard for device studies) compliance architecture are part of the FIH-12™ engagement | Add-on "The Regulatory Architect," $45,000: study protocol from a standardized template, plus investigator brochure (IB) review |
| Data systems and ownership | English-language, monitored "812.28-Ready Data Room" built under ISO 14155 | Base price includes data management on an open-source electronic data capture (EDC) system; EDC setup and licensing and electronic case report form (eCRF) design are the add-on "The Data Core," $65,000. The FAQ says the sponsor owns the data, exported in a standard format |
| FDA strategy | U.S. Regulatory Anchor Plan (FDA Pre-Submission, or Pre-Sub, and investigational device exemption, or IDE, planning), a free Pre-Sub gap analysis with 48-hour turnaround, and a data package built for 21 CFR 812.28 (Title 21 of the Code of Federal Regulations, the FDA rule on accepting device data from outside the U.S.). Acceptance is FDA's decision, per submission | Studies are "fully compliant with the FDA/EMA requirements" (EMA = European Medicines Agency) (products & pricing page) |
| Payment | Set out in the written proposal for your protocol | 50% up front, 20% at ethics committee and competent authority approval, 20% when all subjects are recruited, 10% at trial master file delivery; insurance paid up front (products & pricing page) |
| Proof on the site | Named client programs and 50+ client companies since 2010 (case studies, about page) | Tigermed corporate facts ("more than 50 countries with over 5000 completed trials"). No Try The Trial case studies on its public pages as of 28 September 2026 |
| After FIH | Planned hand-off: bioaccess® owns FIH; RQM+ is the preferred U.S. and European Union (EU) pivotal partner | "Do I have to switch CROs for Phase 2?" is answered "TBD" (FAQ) |
The price, start-up, and payment rows aren't like-for-like. Try The Trial's list price includes investigator site fees for a fixed subject count (15–20 for MedTech Velocity) and excludes insurance, labs, patient travel, protocol writing, and EDC systems. bioaccess®'s figures are published benchmark ranges, not quotes. Try The Trial's 6–7 months covers study start-up; bioaccess®'s 4–8 weeks is ethics-committee approval only. Ask both providers for a written scope with the same subject count, the same inclusions, and a calendar. Try The Trial prices and terms are quoted from its public pages as listed on 28 September 2026 and may change.
Your device, your country. A package run in one provider-selected country fits some programs. A device first-in-human study usually depends on one surgeon-investigator, one procedure, and a regulator with a known calendar. bioaccess® matches those to your device across Panama, El Salvador, Chile, the Dominican Republic, and Brazil.
Implants are the core business, not an exception. Try The Trial lists its device package as non-implantable. bioaccess®'s public case studies include brain, nerve, and venous implants: Axoft and Newrotex in Panama, and Avantec Vascular in El Salvador.
A timeline you can show your board. Under FIH-12™, our 12-month FIH timeline guarantee, we put your protocol-to-last-patient-last-visit timeline in writing. If we miss it for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV. Full terms in your proposal.
Close to home, and built for the FDA file. Same or adjacent U.S. time zones for weekly oversight, a U.S. site option at Amavita Research in Miami when investors or FDA want U.S. patients, ISO 14155 execution, and a data package designed for 21 CFR 812.28. Acceptance is FDA's decision, one submission at a time. After first-in-human, the plan is set: RQM+ is our preferred partner for the U.S. and European pivotal that follows.
Where Try The Trial may be the better fit: drug and biologic Phase 1a programs that fit one of its published packages and price points; sponsors who prefer a single published list price and are comfortable with the provider selecting the country; and sponsors who specifically want Tigermed's global organization behind the study.
Questions to ask any fixed-price first-in-human offer, bioaccess® included: Is my device in scope (implantable or not, the procedure, sterility, software, import)? Which country, and who picks it? Which regulator and ethics committee, and what's a realistic calendar for each? Is the study run to ISO 14155 and designed for 21 CFR 812.28? What sits outside the price (insurance, device import, labs, imaging, patient travel, extra subjects, protocol writing, data systems, amendments)? Is the timeline written into the contract, and what happens if it's missed? What's paid up front, and what triggers each payment? Who owns the data, and who runs the next study?
Try The Trial is a fixed-price, fixed-scope program for first-in-human (FIH) and proof-of-concept clinical trials. It is operated by TryTheTrial OÜ, an Estonian private limited company (registration code 17367880), and its site describes it as a product of Tigermed EMEA (Europe, Middle East and Africa). Its FAQ names its contract research organization (CRO) partners as Tigermed EMEA, Vantage, and others. As listed on 28 September 2026, it offers five core packages from $545,000 to $795,000, each run in one country selected by Tigermed EMEA.
As listed on its products and pricing page on 28 September 2026: MedTech Velocity $545,000, Pharma Genesis and Cardio Sprint $645,000 each, Neuro Synapse $695,000, and Onco Discovery $795,000. Add-ons are $45,000 for protocol writing and investigator brochure review ("The Regulatory Architect") and $65,000 for electronic data capture setup and case report form design ("The Data Core"). Insurance, laboratory and clinical services, third-party vendors, and patient travel are excluded from the base price. Payment is 50% up front, 20% at ethics and competent authority approval, 20% when all subjects are recruited, and 10% at trial master file delivery.
Its only device package, MedTech Velocity, is described as a standardized early-phase trial for non-implantable medical devices with 15 to 20 subjects. For other programs, the site says it will set a custom fixed price within its listed price points. bioaccess® runs first-in-human studies of implantable devices, with public examples in Panama and El Salvador.
According to its site, each study runs in one country only, selected by Tigermed EMEA as a "Regulatory Bridge" country. The country is not named on its public pages, and a "Tier-1 Geo Unlock" upgrade is offered for the U.S. or Western Europe, with no price listed. With bioaccess®, the sponsor chooses from Panama, El Salvador, Chile, the Dominican Republic, and Brazil, with a U.S. site option in Miami.
Try The Trial lists a study start-up (SSU) of 6 to 7 months and says the overall timeline depends on the protocol. bioaccess® publishes ethics-committee approval in a median of 4 to 8 weeks in Latin America. Under FIH-12™, its 12-month FIH timeline guarantee, bioaccess® puts the protocol-to-last-patient-last-visit (LPLV) timeline in writing; if it misses that timeline for reasons within its control, it credits 100% of its project-management and monitoring fees until LPLV. Full terms are in each proposal.
No. bioaccess® is not affiliated with Try The Trial, TryTheTrial OÜ, Tigermed, or Vantage. bioaccess® is the first-in-human contract research organization (CRO) for medical devices in Latin America, headquartered in Miami and operating since 2010, with a sister clinical research site in Miami.
The FIH-12™ engagement published on bioaccessla.com includes a U.S. Regulatory Anchor Plan (U.S. Food and Drug Administration Pre-Submission and investigational device exemption planning), FIH protocol authoring with ISO 14155 compliance architecture, in-country ethics and regulatory submissions, pre-qualified site activation, an enrollment and retention program, and an English-language data package built for 21 CFR 812.28. A Pre-Submission gap analysis with 48-hour turnaround is included at no extra cost.
Try The Trial's FAQ answers the Phase 2 question with "TBD." bioaccess® plans the hand-off from the start: it runs the first-in-human study, and RQM+ is its preferred partner for U.S. and European pivotal trials.
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