Figures cited from published bioaccess® pages and named public press, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers.
If you searched The Panama Clinic clinical trial, The Panama Clinic first-in-human, Panama Clinic FIH medical device, or “go direct to the site in Panama,” you are usually following a hospital name that showed up in press or a web result. That search is rational. The Panama Clinic is a real surgical site in Panama City. It is also not the operator of the first-in-human file.
bioaccess®’s position is simple and it is not adversarial: The Panama Clinic is the surgical site. A First-in-Human CRO still owns MINSA/CNBI, investigational import, insurance, monitoring, ISO 14155 conduct, and the FDA 21 CFR 812.28 package — plus the option to add another Latin American country if Panama is not the only fit. Sponsors who skip the CRO and email the hospital directly still have to rebuild that stack. The hospital does not become a CRO because a press release named it.
This page is the intercept for that search. It does not clone our country guide Clinical trials in Panama or the March 2026 essay Why Panama is emerging as a top destination for first-in-human medical device and biopharma trials. Those pages stay the Panama operating system. This page answers the site-named query.
Why the hospital name wins the search — and why that is not a CRO
Device press writes the implant, the city, the hospital, and the surgeons. It rarely writes the CRO. A clear public example is Nanochon’s Chondrograft first-in-human program, reported by Medical Device Network (retrieved 23 August 2026). That article: MINSA approval for a Chondrograft first-in-human in articular cartilage defects of the knee; site The Panama Clinic, Panama City; PI Dr Juan Osorio and co-lead Dr Emilio Tufiño (sports-medicine surgeons); patients 22–60 with one or two femoral-condyle and/or trochlear lesions after failed conservative care; Health Canada permission and Ontario recruitment; FDA Breakthrough Device designation for the implant.
That is useful public information about a site-named Panama FIH. It is not a bioaccess® case study. As of this writing, bioaccess® does not list Nanochon as a client on our published pages, and this article will not invent that relationship. The point of citing the press is narrower: this is how a sponsor finds The Panama Clinic without finding the CRO. The same pattern will keep repeating for other devices. Winning the query means answering it as the operator that already ran first-in-human implants at that same hospital — not treating the clinic as a rival.
The Panama Clinic is a site. The CRO is the operator.
A Panama City hospital can provide operating rooms, imaging, bilingual staff, and investigators who have often trained in the United States. That is necessary. It is not sufficient for a first-in-human medical device study that a U.S. board expects to survive FDA review.
What a site can typically do when a sponsor “goes direct”:
- Discuss investigator interest and surgical feasibility.
- Share institutional ethics-committee calendars and hospital research rules.
- Quote procedure, bed, and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- MINSA and CNBI. The national file is not a hallway conversation with a surgeon.
- Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a PI email.
- Clinical trial insurance. Required. Our Panama essay publishes a typical premium range of $5,000–$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for your protocol.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The hospital runs the case. The CRO runs the quality system the FDA will later ask about.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after ISO 14155 / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
- Multi-country optionality. If Panama enrollment or the indication later needs Colombia, El Salvador, Brazil, or another bioaccess® market, a single-hospital MSA will not stretch.
Going direct to The Panama Clinic is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.
How MINSA and CNBI actually work (the short version)
Use the country pages for the full pathway. The facts a sponsor searching this hospital needs on one screen:
Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national health authority sponsors meet on device investigations. Ethics review runs through institutional bioethics committees (Comités Institucionales de Bioética de la Investigación) registered with the Comité Nacional de Bioética de la Investigación (CNBI).
Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:
- On clinical-trials-panama: ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks. Per-patient costs on that page: $12,000–$22,000. A 10-patient FIH is described as typically $200K–$300K. Currency is the U.S. dollar. Miami is about a three-hour direct flight.
- On the March 2026 blog: early-feasibility is ethics-committee-driven (no separate national device-authority step of the INVIMA/ANVISA type); CNBI often 4–8 weeks; conservative submission-to-first-patient envelope 3–5 months including site prep and screening.
Ask for a protocol-specific calendar. Do not treat a hospital hallway estimate as MINSA clearance. bioaccess® manages the submission and keeps the reviewer relationship; that is CRO work, not site work.
All bioaccess® Panama protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. That sentence is already on the country page; it belongs on this intercept too.
Which first-in-human studies has bioaccess® already run at The Panama Clinic?
Two named programs. We will not add a third hospital-level claim we have not verified on a bioaccess® page.
Axoft — ultra-soft BCI, four Panama Clinic implants
Live case study Axoft — Panama First-in-Human → $55M Series A (2026): ultra-soft implantable BCI on a bio-inspired polymer described as 10,000× softer than existing materials; FDA Breakthrough Device Designation (2022). With bioaccess®, the FIH ran at The Panama Clinic — four patients implanted during brain-tumor resection — inside a worldwide effort the same page reports as 11 implants, then a $55M Series A in April 2026 (C.P. Group Innovation; more than $60M raised). Ethics on that page: 4 weeks. bioaccess® ran the regulatory submission, site prep, surgical coordination, and FDA-oriented data collection.
Newrotex — world’s first SilkAxons™ implant
Live case study Newrotex — World’s First SilkAxons™ Nerve Guide Implantation — Panama: investigational silk nerve guide for large-gap peripheral injuries. World-first SilkAxons™ implant at The Panama Clinic through bioaccess®; FIH start August 2025; still investigational; regulatory approval on that page ~2 weeks. bioaccess® found the microsurgery team and ran screening, surgical logistics, implant tracking, and follow-up under ISO 14155-aligned protocols.
The country page also names other Panama work (Watershed Therapeutics; cardiovascular device studies). Those are Panama-country claims, not “at The Panama Clinic” claims, so they stay off this hospital list.
What the CRO still does after you have a hospital name
Once The Panama Clinic is on the slide, the remaining job is the one sponsors skip when they go site-direct:
- Regulatory-fit, not tourism. Panama is fast and bilingual. It is not automatically the right country for every indication or every FDA plan. bioaccess® still runs trials in Colombia and the rest of the platform; country choice is a regulatory-fit review, not a press clipping.
- Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
- Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action. See Can OUS first-in-human data support an FDA IDE submission?.
- A 12-month protocol-to-LPLV written guarantee on the FIH-12™ model published on our First In Humans comparison and country pages — not a hospital “we can start next month” hallway number.
bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates FIH device studies at JCI-accredited hospitals in Panama City. Project managers and monitors are ACRP-certified. That is the operator layer around a site like The Panama Clinic.
Panama-only CRO versus a multi-country FIH platform
If a sponsor has already decided Panama is the only jurisdiction, a Panama-focused specialist is a coherent choice. First In Humans (firstinhumans.com) is the public peer in that category: end-to-end trial facilitation in Panama with CNBI-accredited IRB experience. The live, fair comparison is already published at bioaccess® vs First In Humans. This page will not clone that matrix and will not occupy a first-in-humans-panama-cro slug reserved for that comparison family.
bioaccess®’s difference, as those pages already state: Panama is one market on a multi-country first-in-human platform with U.S. FDA regulatory anchoring (Pre-Sub, IDE, 510(k), De Novo, PMA, HDE, IND), a written 12-month protocol-to-LPLV guarantee, and a documented FIH-to-Fortune-500 pattern (Mitralign → Edwards, ClarVista → Alcon, ForSight VISION5 → Allergan/AbbVie). If country choice is still part of the strategy, lock the site after the regulatory-fit review — do not lock the country because a magazine named one hospital.
Colombia is still on the map
A Panama Clinic search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia (Julio G. Martinez-Clark, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K. Colombia still wins on site network, INVIMA Level 4 credibility, and some investigator pools. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract The Panama Clinic directly?
You can try. A hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in press, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. If the goal is a first-in-human device study — not a courtesy tour — contract the CRO that already ran FIH implants at that site, then let the CRO contract and activate The Panama Clinic as the surgical site.
What does the CRO still do if the hospital is already identified?
Regulatory-fit and country choice; the MINSA and CNBI/institutional ethics packet; insurance; investigational import and device accountability; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative aimed at a later FDA submission; and the option to add another Latin American country if Panama is not enough. The hospital still does the surgery. Those are different contracts.
Which FIH studies has bioaccess® already run at The Panama Clinic?
Two that we will name because they are on live bioaccess® case-study pages: Axoft (BCI; four patients implanted during brain-tumor resection; ethics ~4 weeks; FDA Breakthrough 2022; $55M Series A April 2026 as cited on that page) and Newrotex (world-first SilkAxons™ implant; FIH start August 2025; investigational; approximately 2-week regulatory approval on that page). We do not add Nanochon or any other sponsor to this hospital list. Nanochon’s public press places Chondrograft at The Panama Clinic; it does not make Nanochon a bioaccess® client.
How does MINSA / CNBI work?
MINSA (Ministerio de Salud), through the Dirección Nacional de Farmacia y Drogas, is the national health authority for the investigation. Ethics runs through institutional committees registered with CNBI (Comité Nacional de Bioética de la Investigación). bioaccess®’s country page publishes 3–5 week ethics and a 6–8 week average to first patient with our coordination; the March 2026 blog describes an ethics-committee-driven early-feasibility path and a 3–5 month conservative envelope including site prep. Submissions typically include protocol, investigator brochure, informed consent, and insurance. bioaccess® files and manages the relationship. A surgeon’s email is not a MINSA approval.
Next step
If the search that brought you here was the hospital, start the conversation as the operator: contact bioaccess® or book from First-in-Human CRO. Keep the country system on clinical trials in Panama and the long essay on Panama FIH for medical devices. Named work at this hospital: Axoft and Newrotex.