Category: Navigating Regulatory Landscapes in Latin America

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. Where a card is mentioned, only the locked public LATAM Launch Subscription (USD 7,500/year all-in for the first device family) already published on market-access and the holder hub applies. No unpublished client. No PHI. Always bioaccess®.

If you searched Colombia RA consultant medical device, INVIMA regulatory consultant, or Colombia regulatory affairs consultant medical device, you were looking for registration / operator clarity often mislabeled as freelance advice. This page owns that search intent: registration operator vs freelance advice. It does not flip into “do FIH in Colombia.” No named freelancers. No PHI. Always bioaccess®.

The leak: a consultant who drafts INVIMA dossiers or advises on classification is still not the ethics calendar + IOR + site network + inspection-ready ops stack — and on Colombia, the public FIH line is closed for new trial execution anyway. What remains core is INVIMA commercial medical-device registration and holder / IOR operations. bioaccess® is the LATAM FIH CRO (in countries the public line recommends) and the local RA / IOR operator for Colombia registration.

Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

What the search usually means vs what execution requires

• Search intent often means: someone who “knows INVIMA” for registro sanitario, CCAA importer rules, or historical trial coaching.
• Registration execution requires: Colombian legal entity as titular on the sanitary registration; CCAA importer rules beside the holder; certified translations where required; tecnovigilancia as holder; government fees and RFI ownership — see INVIMA medical device registration checklist.
• A freelance INVIMA RA retainer usually covers: dossier outline and agency etiquette — not own-entity titular and not post-market as holder.
• FIH execution is not the offer on this page. Historic Colombia FIH copy elsewhere is not a reason to book a new INVIMA clinical CTA from this intercept.

INVIMA registration operator stack (not new FIH)

Use Colombia INVIMA Registration Holder / IOR and the checklist above. Locked public card: LATAM Launch Subscription USD 7,500/year all-in for the first device family on market-access and LATAM Registration Holder and IOR. We will not invent INVIMA freelancer rates. Submission Guarantee language on the hub is workmanship (complete dossier, certified language, fees paid on schedule) — not a regulator-clock guarantee.

For context on why sponsors still find “CRO in Colombia” in search, see CRO in Colombia — read that page together with the public line above. Country 2 for new FIH remains Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA from an RA-consultant intercept.

Investigational import (when a protocol runs in a recommended country) is importer of record for clinical trial devices — a trial object, not this Colombia registration SKU.

Registration operator vs freelance advice

1. Who is the titular? INVIMA names a Colombian legal entity. A consultant who helps you appoint is not the titular.
2. Who owns CCAA importer rules? Importer rules sit next to the holder — see the live checklist — not instead of it.
3. Who runs tecnovigilancia after the certificate is live? Holder duty. A one-time filing shop is not that.
4. Who owns RFIs and government fees? Operator clarity beats a vague “we’ll help with INVIMA” email.
5. Who refuses to sell you new FIH in Colombia? bioaccess® — on the public line — while still owning commercial registration.

How sponsors mis-buy “INVIMA RA”

The mis-buy on Colombia is specific: sponsors search INVIMA regulatory consultant when they need either (a) commercial titular / CCAA / tecnovigilancia operations, or (b) historic FIH language that the public line no longer recommends for new trial execution. This page answers (a) and refuses to reopen (b). Use INVIMA medical device registration checklist and INVIMA holder / IOR. For FIH country selection, stay on Panama, Chile, Brazil, Mexico, or El Salvador per the public line. Always bioaccess®.

Frequently asked questions

Is an INVIMA regulatory consultant a CRO?

No. And this page is not selling Colombia FIH CRO execution. It sells clarity on registration operator vs freelance advice, with bioaccess® as the holder / IOR operator for commercial INVIMA work.

Does bioaccess® recommend Colombia for new FIH?

No. Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

Does bioaccess® replace freelancers?

We do not name freelancers. When the job is INVIMA registration holder / IOR, hire the operator on market-access — not only dossier coaching.

Can I use the USD 7,500 card for an investigational device in Colombia?

No. The public card is for already FDA-cleared or CE-marked devices. New FIH in Colombia is not recommended. For investigational import in recommended countries, use the trial IOR blog.

Siblings?

Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Brazil RA Consultant / ANVISA

Next step

Colombia RA / INVIMA search → registration operator path (not new FIH): contact bioaccess® · market-access · INVIMA checklist · INVIMA holder / IOR · CRO in Colombia (with public FIH line) · siblings Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Brazil RA Consultant / ANVISA.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: apply the Colombia public line before anyone sells you a new INVIMA FIH from an RA search; keep Mexico, Brazil, Panama, Chile, and El Salvador on the recommended FIH conversation where the live hubs support it.
• Commercial card owner: if the SKU is already-cleared devices, use the locked public LATAM Launch Subscription on market-access — USD 7,500/year all-in for the first device family — and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This intercept is public content only. It is not leftover-site hospital FIH copy, not insurance underwriting, and not a Magical BTK page. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. Where a card is mentioned, only the locked public LATAM Launch Subscription (USD 7,500/year all-in for the first device family) already published on market-access and the holder hub applies. No unpublished client. No PHI. Always bioaccess®.

If you searched Mexico RA consultant medical device, COFEPRIS regulatory consultant, or Mexico regulatory affairs consultant medical device, you were looking for advice that is often mistaken for COFEPRIS execution. This page owns that search intent: advice vs the operator stack. It does not name freelancers. No PHI. Always bioaccess®.

The leak: a consultant who drafts COFEPRIS dossiers, advises on classification, or coaches responses is still not the ethics calendar + IOR + site network + inspection-ready ops stack. Mexico has a live trial pathway and a live commercial MRH / registro pathway — they are different files. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns both stacks when you hire the operator, not only the memo.

What the search usually means vs what execution requires

• Search intent often means: someone who “knows COFEPRIS” for classification, registro sanitario, or investigational submission coaching.
• Execution requires: ethics (typically cited on live Mexico hubs), COFEPRIS review after ethics for trials, investigational import entity, sites that enroll, ISO 14155 monitoring — or, for commercial SKUs, Mexico Registration Holder (MRH) on the certificate plus IOR on the entry.
• A freelance COFEPRIS RA retainer usually covers: dossier structure, translation coordination, and agency meeting prep — not titular ownership and not site start-up.
• Do not collapse: FDA US agent, EU AR, and MRH into one “Mexico RA” line item.

COFEPRIS stack: trial clocks vs registro

Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance. We will not invent a new COFEPRIS clock on this page.

Commercial MRH / IOR is the holder intercept: Mexico COFEPRIS Registration Holder / IOR. Locked public card: LATAM Launch Subscription USD 7,500/year all-in for the first device family on market-access and LATAM Registration Holder and IOR. Mexico Class III / energy adders already published on that hub stay there — this page is not a second price list. Trial IOR: importer of record for clinical trial devices.

Advice vs execution (Mexico)

1. Classification memo ≠ submission ownership. Who signs, who pays government fees, who owns RFIs?
2. Dossier coach ≠ MRH. Who is the Mexican legal entity on the sanitary registration?
3. Agency etiquette ≠ ethics calendar. Institutional committees still have to sit for FIH / early feasibility.
4. “We know importers” ≠ IOR. Who is on the customs entry for this shipment?
5. Start-up slide ≠ inspection-ready ISF. bioaccess® runs ISO 14155 ops when you hire the CRO stack.

Colombia line (do not leak Mexico success into Colombian FIH)

Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®. A clean Mexico COFEPRIS path is not a reason to book new FIH in Colombia from this page.

How sponsors mis-buy “COFEPRIS RA”

Three common mis-buys show up in the same search cluster. First: treating a classification opinion as if it were ethics + COFEPRIS start-up on clinical-trials-mexico. Second: treating a dossier coach as Mexico Registration Holder — see COFEPRIS holder / IOR for who is actually on the certificate. Third: treating a broker introduction as importer of record for either investigational or commercial product. bioaccess® separates those SKUs on purpose. Always bioaccess®. Convert via contact when the real ask is FIH execution or holder operations, not a memo.

Frequently asked questions

Is a COFEPRIS regulatory consultant a CRO?

No. Consultant advice and CRO / holder execution are different. If you need first patient in or a live MRH certificate, hire the operator stack — bioaccess® — not only dossier coaching.

Does bioaccess® replace freelancers?

We do not name freelancers. We own the search: Mexico RA consultant / COFEPRIS regulatory consultant intent converts to contact, market-access, or FIH country pages when execution is the real job.

Can the LATAM Launch Subscription run FIH?

No. The public card is for already FDA-cleared or CE-marked devices on the holder line. Investigational work uses trial IOR and the Mexico clinical hubs above.

Rates for freelancers or Pure Global?

Not invented here. Only the locked public USD 7,500/year all-in card is cited when a card is mentioned.

Siblings?

Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA

Next step

Mexico RA / COFEPRIS search → operator path: contact bioaccess® · market-access · clinical-trials-mexico · CRO in Mexico · COFEPRIS holder / IOR · siblings Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: apply the Colombia public line before anyone sells you a new INVIMA FIH from an RA search; keep Mexico, Brazil, Panama, Chile, and El Salvador on the recommended FIH conversation where the live hubs support it.
• Commercial card owner: if the SKU is already-cleared devices, use the locked public LATAM Launch Subscription on market-access — USD 7,500/year all-in for the first device family — and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This intercept is public content only. It is not leftover-site hospital FIH copy, not insurance underwriting, and not a Magical BTK page. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

Repeat the thesis in plain language for searchers who skim: hiring a freelance RA consultant is not the same as running FIH, early feasibility, or registration execution. You still need the ethics calendar, IOR/import, site network, and inspection-ready operations. bioaccess® owns that LATAM stack as FIH CRO plus local RA/IOR operator. Convert via contact and market-access. No invented rates. No named freelancers. No PHI. Always write bioaccess® with the registered mark.

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. Where a card is mentioned, only the locked public LATAM Launch Subscription (USD 7,500/year all-in for the first device family) already published on market-access and the holder hub applies. No unpublished client. No PHI. Always bioaccess®.

If you searched regulatory affairs consultant Latin America, local RA consultant LATAM, or LATAM medical device regulatory consultant (not CRO), you were looking for multi-country advice under a label that usually under-delivers the FIH / registration operator stack. This regional umbrella page owns that intent. It points to Mexico (COFEPRIS), Colombia (INVIMA — registration operator focus), Brazil (ANVISA), and Dominican Republic siblings. It does not name freelancers. No PHI. Always bioaccess®.

The leak: “local RA consultant LATAM” is not a multi-country holder / IOR operator, and it is not a FIH CRO. A consultant who drafts dossiers or advises on classification across Mexico, Colombia, Brazil, and the Caribbean is still not the ethics calendar + IOR + site network + inspection-ready ops stack. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns that stack across the public footprint on market-access.

What the search usually means vs what execution requires

• Search intent often means: one person or boutique who “knows LATAM RA” for classification, dossier language, and agency etiquette across several markets.
• Execution requires: per-country ethics calendars; per-country holder / titular / BRH / MRH entities where registration is the SKU; per-shipment IOR; site networks that enroll; ISO 14155 ops that survive inspection.
• A regional RA retainer usually covers: gap assessments, dossier templates, translation vendor lists, and meeting prep — useful, and still not multi-country ownership of certificates or trial start-up.
• Ask two questions: which legal entity is on each country’s certificate, and who owns first-patient-in when the protocol is investigational?

Local RA consultant LATAM ≠ multi-country holder / IOR operator

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is registration holder / titular / detentor / BRH / MRH — named on the certificate — not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” See LATAM Registration Holder and IOR. Importer of record is the entity on the customs entry. A consultancy that helps you appoint a holder is not the holder. bioaccess® own-entity holder / IOR under the locked public LATAM Launch Subscription (USD 7,500/year all-in for the first device family) is the commercial card already published on market-access — we do not invent Pure Global or freelancer rates on this page.

FIH / early feasibility is a different stack: ethics, investigational import, sites, monitoring. Country hubs: clinical-trials-mexico, CRO in Mexico, clinical-trials-brazil, CRO in Colombia (read the Colombia public line before you book FIH). Trial IOR: importer of record for clinical trial devices.

Country siblings (do not collapse into one Gantt)

• Mexico / COFEPRIS: Mexico RA Consultant / COFEPRIS — advice vs execution; MRH / trial clocks stay separate.
• Colombia / INVIMA: Colombia RA Consultant / INVIMA — registration operator vs freelance advice. Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.
• Brazil / ANVISA: Brazil RA Consultant / ANVISA — BRH stack vs freelance advice.
• Dominican Republic: Dominican Republic RA Consultant — FIH often shopped as “RA consultant,” still needs ethics + import + sites.

What bioaccess® still owns after a regional RA quote

1. Multi-country own-entity holder / IOR on the public 19-market footprint named on market-access — not a brochure telling you to hire a local lawyer in each capital.
2. FIH CRO execution where the public line recommends the country — Mexico, Brazil, Panama, Chile, El Salvador, and other live hubs — with ethics, sites, and inspection-ready ops under ISO 14155.
3. Colombia registration without flipping into FIH — INVIMA commercial registration remains core; new FIH in Colombia is not recommended on the public line above.
4. Certified/sworn dossier work inside the published card where the country requires it — do not compare a dossier-only sticker to USD 7,500 all-in.
5. Tecnovigilancia as holder after the certificate is live — a one-time filing shop is not that.

Frequently asked questions

Is an RA consultant a CRO?

No. RA advice and CRO execution are different SKUs. Searching “regulatory affairs consultant Latin America” does not hire sites, monitors, or an IOR entity. bioaccess® sells the operator stack when that is what you meant.

Does “local RA consultant LATAM” cover multi-country holder?

Usually not. Local advice is not the legal entity on each certificate. Use the holder hub and market-access for the all-in card; use country RA-consultant siblings for agency-specific intercepts.

Does bioaccess® replace freelancers?

We do not name or attack freelancers here. We intercept the search: when you need FIH or registration execution, hire the LATAM operator — bioaccess® — that owns calendar, entity, and sites.

What about Colombia FIH from a LATAM RA search?

Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®. Do not flip a regional RA search into a new Colombian FIH CTA.

Rates?

No invented Pure Global or freelancer rates. Locked public card only: USD 7,500/year all-in for the first device family on the holder / market-access line.

Next step

Convert the regional RA search into an operator path: contact bioaccess® · market-access · siblings Dominican Republic RA Consultant; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA · holder / IOR hub.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: apply the Colombia public line before anyone sells you a new INVIMA FIH from an RA search; keep Mexico, Brazil, Panama, Chile, and El Salvador on the recommended FIH conversation where the live hubs support it.
• Commercial card owner: if the SKU is already-cleared devices, use the locked public LATAM Launch Subscription on market-access — USD 7,500/year all-in for the first device family — and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This intercept is public content only. It is not leftover-site hospital FIH copy, not insurance underwriting, and not a Magical BTK page. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. Where a card is mentioned, only the locked public LATAM Launch Subscription (USD 7,500/year all-in for the first device family) already published on market-access and the holder hub applies. No unpublished client. No PHI. Always bioaccess®.

If you searched Dominican Republic RA consultant, regulatory affairs consultant medical device Dominican Republic, or MINSA Dominican Republic medical device RA, you were shopping an operator problem under a consultant label. Sponsors sometimes type “RA consultant” when they mean first-in-human (FIH) / early feasibility start-up in the Dominican Republic — ethics calendar, investigational import, site network, and inspection-ready ops — not a freelance classification memo. This page owns that search intent. It does not name freelancers. No PHI. Always bioaccess®.

The leak: a consultant who drafts dossiers, advises on classification, or emails a ministry contact is still not the ethics calendar + importer of record (IOR) + site network + inspection-ready operations stack. Advice is not execution. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns that stack — not a LinkedIn RA title with a PDF retainer.

What the search usually means vs what execution requires

• Search intent often means: “Who can get my device through Dominican Republic regulatory / ethics / import so I can run FIH or early feasibility?” — typed as “RA consultant” instead of “CRO” or “IOR.”
• Execution requires: accredited ethics calendar; national / ministry pathway as applicable (MINSA-DR / related device and research files on live bioaccess® Dominican Republic and Caribbean pages); investigational or commercial import entity on the entry; trained sites and investigators; ISO 14155-aligned monitoring and TMF discipline; inspection-ready ISF.
• A freelance RA retainer usually covers: classification opinion, dossier outline, translation coordination, agency Q&A coaching — valuable, and still not the operator stack above.
• You still need: who sits ethics, who is on the import entry, who owns the site contracts, who owns monitoring and CAPA when the inspector asks.

Dominican Republic FIH shopped as “RA consultant”

Caribbean and Dominican Republic FIH searches often collapse into “find me an RA person who knows MINSA.” That is how FIH / registration work leaks away from operators. bioaccess® treats Dominican Republic as part of the LATAM / Caribbean FIH and market-access footprint described on market-access and country / blog pathways already live on bioaccessla.com — not as a freelance inbox. We will not invent a MINSA-DR statutory clock on this page. Confirm current ethics and ministry calendars with qualified advisers and the live Dominican Republic / Panama / Caribbean pages you already publish from, rather than treating a Google snippet as start-up.

Investigational import is a different workstream from commercial holder / IOR. See importer of record for clinical trial devices in Latin America. Commercial already-cleared devices sit on the holder line: LATAM Registration Holder and IOR. Do not put FIH import and commercial registro on one Gantt labeled “Dominican Republic RA.”

Operator stack bioaccess® still owns after an RA quote

1. Ethics calendar ownership — committee submission packages, responses, and a real date for first possible enrollment — not a slide that says “ethics TBD.”
2. IOR / import entity — who appears on the customs entry for investigational or commercial product; see the live IOR blog above. A consultant who “helps appoint” is not the entity on the entry.
3. Site network and contracts — investigators, hospital agreements, budgets, and start-up that survive audit. A hallway introduction is not a site.
4. Inspection-ready ops — ISO 14155 monitoring, TMF/ISF discipline, CAPA. Dossier advice does not replace that.
5. Registration holder where the SKU is commercial — own-entity holder / IOR under the locked public LATAM Launch Subscription card (USD 7,500/year all-in for the first device family) already published on market-access and the holder hub. We do not invent freelancer rates for comparison.

Colombia line (cluster hygiene)

Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®. Dominican Republic FIH shopping does not reopen Colombia FIH. Country 2 options stay Panama, Chile, Brazil, Mexico, or El Salvador on the public FIH line — not a new Colombian CTA from this page.

Frequently asked questions

Is an RA consultant a CRO?

No. A regulatory-affairs consultant advises on classification, dossiers, and agency process. A CRO runs protocol execution: ethics, sites, monitoring, data, and inspection readiness. bioaccess® is both the LATAM FIH CRO and the local RA / IOR operator when the SKU requires holder or import — that is the stack gap this search usually hides.

Does bioaccess® replace freelancers?

bioaccess® does not attack named freelancers on this page. We own the search intent: when the job is FIH start-up, registration holder, or IOR, hire the operator that holds the calendar, the entity, and the sites — not only a dossier coach. Sponsors may still use specialist RA advice inside a larger program; that advice is not a substitute for the stack.

Can I run Dominican Republic FIH with “just an RA consultant”?

Not if you mean first patient in under an inspection-ready file. You still need ethics, import, sites, and ops. Use contact for the FIH path and market-access for commercial holder / registration questions.

Do you publish freelancer or Pure Global rates here?

No. We do not invent competitor or freelancer rates. The only card we cite is the locked public LATAM Launch Subscription already on the hub.

Where do Mexico, Colombia, Brazil, and the LATAM hub sit?

Sibling RA-consultant intercepts: Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA.

Next step

If the query that brought you here was Dominican Republic RA consultant / regulatory affairs consultant medical device, convert to the operator path: contact bioaccess® · market-access · siblings Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA. Related: trial IOR · holder / IOR hub.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: apply the Colombia public line before anyone sells you a new INVIMA FIH from an RA search; keep Mexico, Brazil, Panama, Chile, and El Salvador on the recommended FIH conversation where the live hubs support it.
• Commercial card owner: if the SKU is already-cleared devices, use the locked public LATAM Launch Subscription on market-access — USD 7,500/year all-in for the first device family — and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This intercept is public content only. It is not leftover-site hospital FIH copy, not insurance underwriting, and not a Magical BTK page. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim UFPE Recife as a bioaccess® client.

If you searched UFPE Recife first-in-human, Universidade Federal de Pernambuco clinical trial, UFPE CRO, or “go direct UFPE Recife,” you followed a campus string ClinicalTrials.gov still publishes. UFPE in Recife, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Recife UFPE campus. It is not IMIP Recife (already live), not Hospital do Câncer de Pernambuco Recife (already live), not Hospital Agamenon Magalhães Recife, and not Federal University of Pernambucano (separate backlog row). Sharing Recife is not a license to collapse them. UFPE is not IMIP. UFPE is not Hospital do Câncer de Pernambuco.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• UFPE (Recife, Brazil) — canonical NCT string: ALL interventional n=28; DEVICE n=2. Example NCT IDs: NCT01681719, NCT06664242.

Cite canonical ALL n=28 and DEVICE n=2. Do not clone IMIP or Hospital do Câncer de Pernambuco onto this slug.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

That is the leak: a founder searching UFPE Recife first-in-human finds ALL n=28 (DEVICE n=2) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the university can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the university is not built to own for an investigational device:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFPE is not an IMIP file and is not a Hospital do Câncer de Pernambuco file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. 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 GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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. See OUS FIH and FDA IDE.

Do not smear the hospital

UFPE is a serious named Recife campus on the public registry. ALL n=28 and DEVICE n=2 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. 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.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract UFPE Recife directly for a device FIH?

You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as IMIP or Hospital do Câncer de Pernambuco Recife?

No. imip-recife-fih and hospital-cancer-pernambuco-recife-fih are already live. This page is UFPE only.

Did bioaccess® run NCT01681719?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Recife sibling (do not merge): IMIP Recife.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital San José Santiago as a bioaccess® client.

If you searched Hospital San Jose Santiago first-in-human, Complejo Hospitalario San Jose Chile clinical trial, Hospital San Jose CRO, or “go direct Hospital San José Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Hospital San José in Santiago, Chile, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Santiago Hospital San José campus. It is DISTINCT from Hospital Clínico San Borja Arriarán (CMS live — do NOT use San Borja on this slug). Skip PUC Chile on this slug. It is not Fundación Médica San Cristóbal Santiago, not Clínica Dávila Santiago, and not Orlandi Oncología Providencia. Sharing Santiago metro is not a license to collapse them. Hospital San José is not San Borja Arriarán. Hospital San José is not San Cristóbal.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital San José (Santiago, Chile) — canonical NCT string: ALL interventional n=34; DEVICE n=7. Example NCT IDs: NCT01529801, NCT03452254, NCT03917927.

Cite canonical ALL n=34 and DEVICE n=7. Do not clone San Borja Arriarán, San Cristóbal, Dávila, Orlandi, or PUC onto this slug.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

That is the leak: a founder searching Hospital San José Santiago first-in-human finds ALL n=34 (DEVICE n=7) without finding ISP. A named hospital campus is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the hospital can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the hospital is not built to own for an investigational device:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Hospital San José Santiago is not a San Borja Arriarán file and is not a San Cristóbal file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. 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 GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ISP actually works (the short version)

Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

Ask for a protocol-specific calendar. A hospital email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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. See OUS FIH and FDA IDE.

Do not smear the hospital

Hospital San José Santiago is a serious named Chilean campus on the public registry. ALL n=34 and DEVICE n=7 are registry volume, not a punchline. Do not invent a PI. Do not invent PAHO/WHO Level 4 for ISP. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ISP / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. 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.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital San José Santiago directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Hospital Clínico San Borja Arriarán or San Cristóbal?

No. hospital-clinico-san-borja-arriaran-santiago-fih is already live. Fundación Médica San Cristóbal is CMS 96124. This page is Hospital San José Santiago only — do not use San Borja on this slug.

Did bioaccess® run NCT01529801?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct Santiago sibling (do not merge): Hospital Clínico San Borja Arriarán Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Gastromed Anápolis as a bioaccess® client.

If you searched Gastromed Anapolis first-in-human, Gastromed Anápolis clinical trial, Gastromed CRO, or “go direct Gastromed Anápolis,” you followed a campus string ClinicalTrials.gov still publishes. Gastromed in Anápolis, Brazil, is a real named gastroenterology-center string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the center is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Anápolis Gastromed campus. It is not a Brasília Hospital de Base merge, not a Goiânia collapse, and not a São Paulo gastro merge. Anápolis is not Brasília. Gastromed is not Hospital de Base.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Gastromed (Anápolis, Brazil) — canonical NCT string: ALL interventional n=41; DEVICE n=1. Example NCT IDs: NCT02409173.

Cite canonical ALL n=41 and DEVICE n=1. Do not clone Brasília or São Paulo campuses onto this slug.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this center as a client site.

That is the leak: a founder searching Gastromed Anápolis first-in-human finds ALL n=41 (DEVICE n=1) without finding ANVISA. A named center is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named center can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the center can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the center is not built to own for an investigational device:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Gastromed Anápolis is not a Brasília Hospital de Base file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. 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 GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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. See OUS FIH and FDA IDE.

Do not smear the hospital

Gastromed is a serious named Anápolis campus on the public registry. ALL n=41 and DEVICE n=1 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. 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.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Gastromed Anápolis directly for a device FIH?

You can try. The center can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this center. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Hospital de Base Distrito Federal Brasília?

No. hospital-de-base-distrito-federal-brasilia-fih is a different city and campus. This page is Gastromed Anápolis only.

Did bioaccess® run NCT02409173?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Brazil sibling (do not merge): Hospital de Base Distrito Federal Brasília.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Federal University of São Carlos as a bioaccess® client.

If you searched Federal University of Sao Carlos first-in-human, UFSCar clinical trial, Universidade Federal de Sao Carlos CRO, or “go direct Federal University of São Carlos,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of São Carlos (UFSCar) in São Carlos, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named São Carlos UFSCar campus. It is not Beneficência Portuguesa São Paulo (already live; avoid near-dup collapse), not Faculdade de Medicina do ABC, and not Federal University of Santa Maria. Sharing a Federal University name is not a license to collapse them. UFSCar is not Beneficência Portuguesa. UFSCar is not ABC.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Federal University of São Carlos (São Carlos, Brazil) — canonical NCT string: ALL interventional n=43; DEVICE n=13. Example NCT IDs: NCT01090271, NCT01106755, NCT01770938.

Cite canonical ALL n=43 and DEVICE n=13. Do not clone Beneficência Portuguesa or ABC onto this slug. Example device NCT IDs use the first 3 of the device list; full device list remains in the backlog.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

That is the leak: a founder searching Federal University of São Carlos first-in-human finds ALL n=43 (DEVICE n=13) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the university can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the university is not built to own for an investigational device:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFSCar is not a Beneficência Portuguesa file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. 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 GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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. See OUS FIH and FDA IDE.

Do not smear the hospital

Federal University of São Carlos is a serious named Brazilian campus on the public registry. ALL n=43 and DEVICE n=13 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. 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.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Federal University of São Carlos directly for a device FIH?

You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Beneficência Portuguesa São Paulo?

No. beneficencia-portuguesa-sao-paulo-fih is already live. This page is Federal University of São Carlos only.

Did bioaccess® run NCT01090271?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Brazil sibling (do not merge): Beneficência Portuguesa São Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim FLENI Buenos Aires as a bioaccess® client.

If you searched FLENI Buenos Aires first-in-human, FLENI Argentina clinical trial, FLENI CRO, or “go direct FLENI Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. FLENI in Buenos Aires, Argentina, is a real named neurology-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ANMAT, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Buenos Aires FLENI campus. It is not Psoriahue CMS 96118, not IDIM CMS 96119, not Centro Medico Arsema (batch 55), and not Instituto Privado Kremer Córdoba. Sharing Buenos Aires / Argentina is not a license to collapse them. FLENI is not Psoriahue. FLENI is not IDIM.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• FLENI (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=52; DEVICE n=1. Example NCT IDs: NCT07475611.

Cite canonical ALL n=52 and DEVICE n=1. Do not clone Psoriahue, IDIM, or Arsema onto this slug.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this institute as a client site.

That is the leak: a founder searching FLENI Buenos Aires first-in-human finds ALL n=52 (DEVICE n=1) without finding ANMAT. A named institute is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named institute can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the institute can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the institute is not built to own for an investigational device:

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at FLENI is not a Psoriahue file and is not an IDIM file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. 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 GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANMAT actually works (the short version)

Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

Ask for a protocol-specific calendar. A hospital email is not ANMAT clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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. See OUS FIH and FDA IDE.

Do not smear the hospital

FLENI is a serious named Buenos Aires campus on the public registry. ALL n=52 and DEVICE n=1 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANMAT / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. 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.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract FLENI Buenos Aires directly for a device FIH?

You can try. The institute can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this institute. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Psoriahue or IDIM Buenos Aires?

No. Psoriahue is CMS 96118. IDIM is CMS 96119. This page is FLENI only.

Did bioaccess® run NCT07475611?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. CABA sibling (do not merge): Psoriahue.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Instituto Nacional de Cardiologia Rio de Janeiro as a bioaccess® client.

If you searched Instituto Nacional de Cardiologia Rio de Janeiro first-in-human, INC Rio clinical trial, INC Brazil CRO, or “go direct Instituto Nacional de Cardiologia Rio de Janeiro,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Cardiologia in Rio de Janeiro, Brazil, is a real named cardiology-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Rio de Janeiro INC campus. It is DISTINCT from instituto-nacional-cardiologia-ignacio-chavez-fih (Mexico — different country, different regulator). It is not Oncoclínicas Rio de Janeiro (already live; do not near-dup merge). Sharing an Instituto Nacional de Cardiologia name is not a license to collapse Mexico and Brazil. INC Rio is not Ignacio Chávez. INC Rio is not Oncoclínicas.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Instituto Nacional de Cardiologia (Rio de Janeiro, Brazil) — canonical NCT string: ALL interventional n=52; DEVICE n=4. Example NCT IDs: NCT04766554, NCT04861805, NCT05572736.

Cite canonical ALL n=52 and DEVICE n=4. Do not clone Ignacio Chávez Mexico or Oncoclínicas Rio onto this slug.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this institute as a client site.

That is the leak: a founder searching Instituto Nacional de Cardiologia Rio de Janeiro first-in-human finds ALL n=52 (DEVICE n=4) without finding ANVISA. A named institute is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named institute can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the institute can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the institute is not built to own for an investigational device:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at INC Rio is not an Ignacio Chávez Mexico file and is not an Oncoclínicas file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. 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 GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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. See OUS FIH and FDA IDE.

Do not smear the hospital

Instituto Nacional de Cardiologia Rio de Janeiro is a serious named Brazilian campus on the public registry. ALL n=52 and DEVICE n=4 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. 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.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Instituto Nacional de Cardiologia Rio de Janeiro directly for a device FIH?

You can try. The institute can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this institute. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Instituto Nacional de Cardiología Ignacio Chávez or Oncoclínicas Rio?

No. instituto-nacional-cardiologia-ignacio-chavez-fih is the Mexico campus. oncoclinicas-rio-de-janeiro-fih is already live. This page is Instituto Nacional de Cardiologia Rio de Janeiro only.

Did bioaccess® run NCT04766554?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct Mexico sibling (do not merge): Instituto Nacional de Cardiología Ignacio Chávez.

Julio G. Martinez-Clark, CEO · bioaccess®