Category: Challenges and Solutions for Medtech Startups

If you typed ACLIRES into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about ACLIRES (LinkedIn company page) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What ACLIRES publishes

ACLIRES-PERU S.A.C. is the Peruvian entity linked to Aclires International, a boutique CRO whose public company profile describes drug clinical research services, including infectious disease. ACLIRES-PERU appears as ROIC-232 in the INS register of research organizations (OIC).

ACLIRES vs bioaccess®

Dimension	ACLIRES	bioaccess®
Core focus	Boutique drug CRO (Peru entity of Aclires International)	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need a boutique drug CRO with a Peru registration, ACLIRES’ published profile matches.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including ACLIRES, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the ACLIRES public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Genexion into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Genexion (INS register of research organizations (OIC)) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Genexion publishes

Genexion S.A.C. (Genexion Perú) is a Lima-based (Miraflores) research organization registered in the INS register of research organizations (OIC) (ROIC-200/315). We did not find a current company website. Public INS trial listings associate it with Phase III drug research.

Genexion vs bioaccess®

Dimension	Genexion	bioaccess®
Core focus	Peru drug research organization (INS-registered)	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need an INS-registered local organization for a Phase III drug study in Peru, Genexion’s public registration matches.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Genexion, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the Genexion public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Impacta into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Impacta (impactaperu.org) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Impacta publishes

Asociación Civil Impacta Salud y Educación is a Lima non-profit whose website centers on HIV research, education and community programs, and an institutional bioethics committee. It appears as ROIC-77 in the INS register of research organizations (OIC), and it is listed as a study site on ClinicalTrials.gov records for HIV prevention research with academic partners.

Impacta vs bioaccess®

Dimension	Impacta	bioaccess®
Core focus	Non-profit HIV prevention research site	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need a Lima site with long experience in HIV prevention research, Impacta’s public record matches.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Impacta, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the Impacta public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Vía Libre into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Vía Libre (vialibre.org.pe) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Vía Libre publishes

Asociación Vía Libre is a Lima non-profit focused on HIV. Its website describes a specialized health center, clinical laboratory, pharmacy, research activity and an institutional bioethics committee. It appears as ROIC-367 in the INS register of research organizations (OIC), and it is listed on ClinicalTrials.gov records for HIV research with academic partners.

Vía Libre vs bioaccess®

Dimension	Vía Libre	bioaccess®
Core focus	HIV NGO, research site and ethics committee	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need a Lima research site or ethics review for HIV-related studies, Vía Libre’s public record matches.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Vía Libre, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the Vía Libre public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Científica CRO into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Científica CRO (cientificacro.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Científica CRO publishes

Científica CRO SAC is a Lima-based (Pueblo Libre) CRO. Its website lists protocol and essential-document writing, feasibility and project management, clinical monitoring, regulatory affairs, active and passive pharmacovigilance, quality management, data management and statistics, systematic reviews, scientific writing, training and translations. It appears as ROIC-337 in the INS register of research organizations (OIC).

Científica CRO vs bioaccess®

Dimension	Científica CRO	bioaccess®
Core focus	Peru monitoring, regulatory, PV, medical writing	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need Peru-based monitoring, regulatory, pharmacovigilance or writing support, Científica CRO’s published services match.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Científica CRO, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the Científica CRO public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Latamciencias into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Latamciencias (LinkedIn company page) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Latamciencias publishes

Latinoamericana de Ciencias SAC (Latamciencias) is a Lima-based CRO. Its public company profile describes clinical monitoring, pharmacovigilance and regulatory affairs services. It appears as ROIC-289 in the INS register of research organizations (OIC).

Latamciencias vs bioaccess®

Dimension	Latamciencias	bioaccess®
Core focus	Peru monitoring, PV, regulatory	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need Peru-based monitoring, pharmacovigilance or regulatory support, Latamciencias’ published services match.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Latamciencias, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the Latamciencias public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed INMENSA into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about INMENSA (ClinicalTrials.gov) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What INMENSA publishes

INMENSA (Investigaciones Médicas en Salud) is a non-profit research organization in Lince, Lima, focused on HIV and infectious-disease research. It appears as ROIC-166 in the INS register of research organizations (OIC), and it is listed as a study facility on ClinicalTrials.gov records that include ACTG network and industry-sponsored infectious-disease trials.

INMENSA vs bioaccess®

Dimension	INMENSA	bioaccess®
Core focus	Non-profit HIV and infectious-disease research site	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need an experienced research site for HIV or infectious-disease trials in Lima, INMENSA’s public record matches.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including INMENSA, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the INMENSA public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Peruvian Clinical Research (PCR) into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Peruvian Clinical Research (PCR) (pcr.pe) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Peruvian Clinical Research (PCR) publishes

Peruvian Clinical Research describes itself on its Spanish-language site as a Peruvian company offering clinical research, a licensed drug warehouse (droguería), regulatory consulting and pharmacovigilance. It appears as registered research organization ROIC-117 in the INS register of research organizations (OIC). On ClinicalTrials.gov it is listed as sponsor or collaborator on studies that include a transcranial laser device study in major depressive disorder (NCT05435820, NCT06934135) and a CDC-led influenza vaccine study (NCT06054269).

Peruvian Clinical Research (PCR) vs bioaccess®

Dimension	Peruvian Clinical Research (PCR)	bioaccess®
Core focus	Peru clinical operations, droguería (importer/warehouse), PV and regulatory	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need a Peru-based team that combines study operations with local import and warehousing of investigational product, PCR’s published services match.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Peruvian Clinical Research (PCR), for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the Peruvian Clinical Research (PCR) public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Gotuzzo Asociados into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Gotuzzo Asociados (LinkedIn company page) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Gotuzzo Asociados publishes

Gotuzzo Asociados S.A.C. is a Lima-based (Miraflores) clinical research services firm. Its public company profile describes services such as acting as legal representative before Peru’s INS, regulatory affairs, monitoring, investigational product import and translation. It appears as ROIC-96 in the INS register of research organizations (OIC).

Gotuzzo Asociados vs bioaccess®

Dimension	Gotuzzo Asociados	bioaccess®
Core focus	Peru legal representation, regulatory, monitoring	First-in-human and early feasibility studies for medical devices
Geography	Peru (Lima)	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need an INS legal representative and local regulatory and monitoring support for a drug study in Peru, Gotuzzo Asociados’ published services match.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Gotuzzo Asociados, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

Ready to compare a proposal? Request a first-in-human study proposal.

Facts from the Gotuzzo Asociados public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

General information, not legal or regulatory advice. QLINICO Consulting is a separate, independent company. bioaccess® is not affiliated with, endorsed by, or sponsored by QLINICO Consulting, and this page does not describe, evaluate or compare QLINICO Consulting’s services. The checklist below applies equally to every provider, including bioaccess®. For information about QLINICO Consulting, contact that company directly. Regulatory requirements and timelines change; confirm them for your protocol with MINSA and your ethics committee. Last reviewed 21 October 2026.

Sponsors planning an early clinical study in Panama will come across several providers, including bioaccess® and QLINICO Consulting. This page does not evaluate any of them; it sets out the questions we suggest asking any Panama CRO, including us, and explains where bioaccess® fits. Panama is a strong choice for first-in-human device work, and the CRO you pick shapes how fast and how cleanly that study runs.

Why sponsors choose Panama for first-in-human studies

In April 2026 Panama published Decreto Ejecutivo No. 21, implementing Ley 84 of 2019. Under Article 91, for clinical trials MINSA and a CNBI-accredited Type II bioethics committee (CBI) evaluate the protocol in parallel, and studies are registered on MINSA’s RESEGIS platform before they start. When the Spanish file is complete and the right committee is selected, in our experience startup has typically taken roughly 30 to 45 days; timelines vary by study and committee, so confirm them per protocol. More detail: Panama and El Salvador parallel review.

What to check when choosing a Panama first-in-human CRO

Ask every bidder the same questions and get the answers in writing. These are the questions we would expect a sponsor to put to bioaccess® as well.

• First-in-human track record. Which first-in-human or early feasibility device studies has the team run, in which device classes, and can references confirm them?
• Regulatory and ethics pathway. How will the file reach a CNBI-accredited Type II CBI, how will RESEGIS registration be handled, and who owns import permits for the investigational device?
• Independent medical and safety oversight. Who is the named medical monitor, how are adverse events escalated, and how is medical-monitor safety review kept separate from the investigational site’s clinical team, as ISO 14155:2020 and the protocol require?
• Insurance and sponsor representation. How are clinical trial insurance and local legal representation for a foreign sponsor arranged?
• FDA-ready data. Will the study meet 21 CFR 812.28 and ISO 14155:2020, with an inspection-ready trial master file and source documents an English-speaking inspector can follow? See Panama and El Salvador FIH data for FDA.
• Continuity planning. Who are the named project manager, clinical monitor and data manager for your study, and what is the written continuity plan if a team member, site or country is delayed?
• Scope clarity. Ask each bidder to map its price to a line-item scope (regulatory, ethics, monitoring, data management, medical monitoring, insurance, importation, sponsor representation) so bids can be compared on the same basis.

Where bioaccess® fits

• First-in-human focus. bioaccess® is a first-in-human CRO focused on the Americas, running first-in-human and early feasibility trials for medtech, biotech, biopharma and radiopharma, with neurotechnology among its therapeutic areas.
• FDA strategy from Miami. We plan each study around the sponsor’s FDA endgame, then run it where it moves fastest.
• Panama pathway. We work with MINSA and with Panama’s ethics committee pathway under Decreto Ejecutivo No. 21 of 2026.
• Latin American network. Since 2010 we have supported more than 50 client companies, work with more than 100 sites, and cover 19 Latin American and Caribbean countries for device registration and market access, so a Panama study can have a second country ready if needed. See Latin America rapid-startup archetypes.

Frequently asked questions

Is bioaccess® connected to QLINICO Consulting or any other Panama CRO?

No. bioaccess® is an independent contract research organization with no affiliation with QLINICO Consulting or any other Panama provider. This page does not evaluate other providers; sponsors should obtain information about them directly.

What should a sponsor check before choosing a CRO in Panama?

Ask every bidder for documented first-in-human experience in your device class, how it will route the file to a CNBI-accredited Type II ethics committee and register it in RESEGIS, who provides medical monitoring and safety oversight, how insurance and local sponsor representation are handled, how the trial master file is kept inspection-ready for FDA under 21 CFR 812.28, and what the backup plan is if a single site or country slows down.

How long does clinical trial startup take in Panama?

Under Decreto Ejecutivo No. 21 of 2026, Article 91, MINSA and an accredited Type II ethics committee review high-risk and clinical-trial protocols in parallel. When the Spanish file is complete and the right committee is selected, in our experience startup has typically taken roughly 30 to 45 days; timelines vary by study and committee, so confirm them per protocol.

Can first-in-human data from Panama support an FDA submission?

Yes, when the study is designed for 21 CFR 812.28 from day one: conduct in accordance with good clinical practice (FDA recognises ISO 14155:2020 as a consensus standard, and conformance supports but does not by itself establish GCP compliance), independent ethics review, documented informed consent, monitoring, and a trial file FDA can inspect.

Related pages

• Parallel review in Panama and El Salvador
• Using Panama FIH data with FDA
• Panama medical device registration (MINSA DNDM)

Planning a first-in-human study in Panama? Talk to bioaccess®.