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®.