By Julio G. Martinez-Clark
CEO, bioaccess®
General information, not legal or regulatory advice. Durations marked “bioaccess® experience” are planning estimates from the study timelines (Gantt charts) we have prepared for sponsors. They are not legal deadlines or guaranteed turnarounds. Legal deadlines are cited to the regulation or official page. Every ethics committee and regulator applies its own procedures, so confirm the timeline for your country and site before you commit to a date. Sources last checked: 29 October 2026.
In this guide: The short answer · Timeline at a glance · What you need to send us · The phases · Who does what · Country notes · Legal clocks vs real-world data · What slows activation · Insurance · Readiness checklist · Glossary · FAQ
The short answer
In our recent plans, getting a clinical trial site in Latin America ready for its first patient took about 8 to 9 months from a protocol synopsis, or about 4.5 to 6 months once the full protocol was final, in the countries where ethics and regulatory reviews are quickest. Where the regulator reviews only after the ethics committee has approved, or has a longer clock, add about 1 to 4 months based on the published review clocks, and more if the regulator sends questions.
The phases are industry standard and the same for drug and device trials, so this guide applies to both. Durations can differ where a country has a drug-specific regulator review or a device import or inspection step. Those are flagged in the country notes.
The biggest driver is the final study protocol. The site search can start from a synopsis. Translation, the submission package, insurance and the budget all wait for the final protocol.
What “activated” means. The site has its approvals, signed contract, insurance, product on site and trained staff, and the sponsor has authorized it to enroll patients.
Timeline at a glance
| Phase | Illustrative start → finish |
|---|---|
| 1. Protocol (synopsis → final) | Month 0 → 3 |
| 2. Site and investigator selection | Month 0 → 3 |
| 3–4. Translation and submission package | Month 3 → 4.5 |
| 5. Insurance | Month 3 → 4.5 |
| 6. Ethics and regulator review (one round of questions) | Month 4.5 → 7 |
| 7. Contract and budget | Month 3 → 5 |
| 8. Import | Month 4.5 → 7 |
| 9. Site initiation → first patient | Month 7 → 9 |
Illustrative schedule from bioaccess® experience in the quickest-review countries. Overlapping bars run at the same time; protocol changes, country requirements and questions can shift these dates. Where the regulator reviews after the ethics committee, phase 6 stretches by about 1 to 4 months.
Key numbers
- 8 to 9 months: protocol synopsis to first patient, in our recent plans (quickest-review countries).
- 4.5 to 6 months: final protocol to first patient, in our recent plans.
- 30 to 60 days: ethics committee first answer (bioaccess® experience).
- About 3 to 6 weeks: what one round of questions added in our plans.
- 31.4 weeks: average from site identification to completed start-up in a global industry benchmark, not specific to Latin America (Tufts CSDD, 2018).
What you need to send us to start
- A protocol synopsis, as early as possible. It lets us start the site and investigator search and the feasibility checks.
- The full protocol, with the investigator’s brochure (or, for a device, the instructions for use and a technical summary), the informed consent form and the case report forms. Translation and the submission package start once these are final.
- Product documents for the submission, such as manufacturing or quality certificates, specifications and labels. We confirm the exact list for each country.
- Insurance: the policy and certificate from your broker, once the site and investigator are known (see below).
- Contract and budget decisions: who signs, payment terms, and who acts as importer of record (the local company legally responsible for bringing the product into the country).
The phases, step by step
Phases marked in parallel run at the same time as others. A good plan overlaps everything that can overlap.
| # | Phase | What happens | Who does it | Typical duration |
|---|---|---|---|---|
| 1 | Protocol: synopsis, then full protocol | The sponsor writes the protocol. We review it for local ethics and regulatory expectations, usually over two review rounds. | Sponsor, with bioaccess® review | Depends on the sponsor. In our recent plans, the protocol took about 2.5 to 3 months from first draft to final, and up to about 4 months until the consent form and brochure were also final. |
| 2 | Site and investigator search and selection (in parallel with phase 1, from the synopsis) | We identify candidate investigators, sign confidentiality agreements, send feasibility questionnaires, hold video calls and a pre-study visit, and write a site report for your approval. | bioaccess®, sites; sponsor approves | 30 to 45 days to shortlist sites (up to 60 around the holidays). 2 to 3 months including the pre-study visit and signed site report. Plan on the longer figure. (bioaccess® experience) |
| 3 | Translation (protocol first) | Translation of the protocol, consent form, investigator’s brochure, case report forms, labels and insurance certificate (certified where the country requires it), then our quality review. | Translators; bioaccess® review | About 4 weeks. In our recent plans, final documents to translated, submission-ready documents took 27 to 35 calendar days; the longer one ran over the year-end holidays. (bioaccess® experience) |
| 4 | Submission package (dossier) (overlaps with translation) | Country and site forms, local consent form, investigator CVs and Good Clinical Practice (GCP) certificates, site letters, product certificates, insurance certificate. | bioaccess®, site, sponsor | 30 to 45 days once the protocol is final, overlapping with translation. The final assembly itself takes days to about two weeks. (bioaccess® experience) |
| 5 | Clinical trial insurance (in parallel) | The broker quotes and binds a policy, local where the country requires it. Insurers usually need the full protocol, the countries, the sites and investigators, and the number of participants. | Sponsor and broker; bioaccess® reviews the certificate | Bound after the site and investigator are chosen. In a recent plan, the policy was issued about 6 weeks after site selection. |
| 6 | Ethics committee and regulator review | The ethics committee responsible for the chosen site (in our experience, often the hospital’s own) reviews the study. The regulator reviews at the same time or afterwards, depending on the country (table below). Questions from either one add a response round. | Ethics committee, regulator; bioaccess® manages the answers | 30 to 60 days to the committee’s first answer. About 7 to 13 weeks to approval if there is one round of questions. Add the regulator’s time where it comes afterwards. (bioaccess® experience) |
| 7 | Contract and budget (in parallel with phases 3 to 6) | The clinical trial agreement and site budget are negotiated with the hospital and signed. Some countries ask for the signed contract inside the submission. | bioaccess®, site, sponsor | About 1 to 2 months, in parallel. (bioaccess® experience) |
| 8 | Import of the investigational product (in parallel) | Import permit, shipment, customs clearance and delivery to the site. Some countries also inspect devices before use. | Importer of record, bioaccess®, sponsor | About 5 weeks to 3 months; the longer end is where the authority inspects the device. Start the paperwork early. (bioaccess® experience) |
| 9 | Site initiation and activation | Site initiation visit and training, data system access, sponsor activation letter, then first patient. The data system build runs in parallel, well before this step. | Sponsor, monitor, site, bioaccess® | About 1 to 10 weeks, depending on scheduling and on whether the product has cleared import. (bioaccess® experience) |
How it adds up (bioaccess® experience, quickest-review countries)
- Month 0 to 3: the protocol is finalized (phase 1). Site and investigator selection runs at the same time (phase 2).
- Month 3 to 4.5: translation and submission package (phases 3 and 4). Insurance is bound about 6 weeks after the site is chosen (phase 5). Contract and budget negotiation starts (phase 7).
- Month 4.5 to 7: ethics and regulatory review, including one round of questions (phase 6). Import runs alongside (phase 8).
- Month 7 to 9: site initiation and first patient (phase 9).
One round of questions from the ethics committee or regulator added about 3 to 6 weeks in our plans. Most legal review clocks stop while the sponsor is answering questions, so a “30-day” review can take much longer on the calendar.
Who does what
This is the usual division of work in bioaccess® practice. We confirm filing, signing, import and training responsibilities for each study.
| Phase | Sponsor | bioaccess® | Site and investigator | Ethics committee / regulator | Broker / insurer |
|---|---|---|---|---|---|
| Protocol | Writes and approves | Reviews for local expectations | Gives feasibility input | ||
| Site selection | Approves the site report | Searches, qualifies, visits | Completes feasibility | ||
| Translation and submission package | Supplies source documents and product certificates | Translates, reviews, assembles | Supplies CVs, GCP certificates, site letters | ||
| Insurance | Buys the policy | Reviews the certificate for local rules | Quotes and issues | ||
| Ethics and regulator review | Answers scientific questions | Files and manages answers | Signs as investigator | Reviews and decides | |
| Contract and budget | Approves terms, signs where a party, funds agreed payments | Negotiates | Negotiates and signs | ||
| Import | Ships product | Coordinates permits | Receives and stores product | Issues permits where required | |
| Site initiation | Issues the activation letter | Coordinates | Completes training and readiness checks; opens enrollment after sponsor authorization |
Country notes: who reviews, and in what order
At a glance. Ethics and regulator at the same time: Brazil (the submissions), and Panama for high-risk research. Shared platform, ethics first: El Salvador. One after the other: Costa Rica, Colombia, Mexico, Peru, Ecuador. Check for your study: Chile, Argentina, Dominican Republic, Guatemala, Uruguay.
What business days mean in practice. 30 business days is about 6 weeks on the calendar, 60 business days about 3 months, and 90 business days about 4 months, before public holidays.
The table shows what public regulations or official pages say. Where we add our own experience, it is marked bioaccess® experience. Committee meeting calendars and real turnaround are practice, and they vary by committee.
| Country | Ethics and regulator: same time or one after the other? | Published review clock |
|---|---|---|
| Panama | Same time. For high-risk research, the Ministry of Health (MINSA) technical review runs alongside the ethics review, and its findings must be resolved before the committee’s final decision (Executive Decree 21 of 2026, Art. 91). | Registry receipt within 3 business days (Art. 86). Ethics review up to 20 business days for ordinary review and 10 for expedited. If it goes back to the full committee, the total is 30 business days, and the time spent answering questions is not counted (Arts. 44 and 45). Where medicines or health products are used, the National Directorate of Pharmacy and Drugs responds within 15 business days (Art. 95). |
| El Salvador | One shared SRS–CNEIS platform. The official SRS route lists ethics approval by the national committee (CNEIS) before the regulator’s trial authorization. | Official SRS route: research site registration 20 business days; CNEIS approval 20 business days; SRS trial authorization 20 business days; special import permit 24 to 72 business hours. bioaccess® experience: first responses in about 3.5 to 7 weeks; approval in about 47 days without questions, and 67 to 85 days with one round of questions. |
| Costa Rica | Accredited ethics committee (CEC) first, then registration with the national council (CONIS). | CONIS acknowledges a complete registration within 5 business days, which registers the protocol provisionally; its technical report is due within 10 business days of assignment (CONIS procedure, 2025). At social security (CCSS) hospitals, research can start 8 days after notice of CONIS registration and delivery of the ethics approval documents (CCSS memo CENDEISSS-AB-0115-2024). |
| Chile | Drug trials need both a favorable report from an accredited ethics committee and authorization from the regulator, ISP (Exempt Resolution 5161). | InvestChile reports a 45-day term for drug trial authorization and an average evaluation of 28 business days. bioaccess® experience (device study): a notification to the health authority after ethics approval, acknowledged in about 16 days. |
| Colombia | The ethics committee first, then INVIMA. bioaccess® runs first-in-human studies in Colombia now. | For protocols with investigational medicines, INVIMA gives its first response within 60 business days. The sponsor then has 30 days to reply, and INVIMA decides within 30 days of the reply (INVIMA guide ASS-RSA-GU039 v6, 3.5). |
| Brazil | Can be submitted at the same time. A drug trial starts only after both approve. | Ethics committee: 10 working days to check completeness, then 30 days from acceptance of the documentation for the opinion (Law 14,874). ANVISA: 90 business days for drug trial dossiers (RDC 945). |
| Mexico | The institution’s ethics and research committees first, then COFEPRIS. | COFEPRIS: maximum 30 calendar days for protocol authorization (DOF agreement of 28 April 2025). |
| Argentina | Confirm the ethics steps and their order for your study. | ANMAT, for clinical pharmacology (drug) studies: 20 business days of technical review plus 10 of administrative review for low-risk and special studies, and 35 plus 10 for the rest (Disposition 7516/2025). |
| Peru | The ethics committee first, then the national institute of health (INS). | INS: up to 30 working days. |
| Dominican Republic | Review by the national bioethics council (CONABIOS). Confirm whether a regulator review runs alongside for your study. | CONABIOS: final result within 45 business days (21 calendar days for urgent protocols). Submit at least 60 days before the planned start. |
| Guatemala | Two reviews, an ethics committee and the regulator (DRCPFA), for drugs and devices (Ministerial Agreement 206-2021). | DRCPFA: authorization within 30 business days of complete documentation (Ministerial Agreement 206-2021). |
| Ecuador | The ethics committee (CEISH) first, then the regulator, ARCSA. Device trials follow the drug procedure until device rules are issued. | ARCSA: document check in 7 days, then up to 60 days for the technical review (extendable by 30). The signed contracts and an insurance policy from an insurer registered in Ecuador are part of the ARCSA file. |
| Uruguay | Registration with the Ministry of Public Health (MSP), then MSP authorization where it applies. The authorization file includes the protocol and consent form approved by the institutional ethics committee. | Ethics committees: 60 days (Decree 158/019). Confirm the MSP clock with the ministry. |
For each regulator’s legal clock next to published real-world approval times, see our guide to clinical trial approval times in Latin America, the US and Canada.
Drugs and devices. The phases are the same for both. The differences are country steps. Chile’s ISP authorization, Brazil’s 90-business-day ANVISA clock, Colombia’s INVIMA clock and Argentina’s ANMAT clock above are the rules for drug trials. Devices may need an extra import or inspection step, as in El Salvador.
Legal clocks vs what actually happens
The country table mixes published review clocks with labeled bioaccess® experience. A review deadline is not an end-to-end activation estimate. Real elapsed time can sit far from the legal clock, in either direction. In some countries the clock stops while the sponsor answers questions, holidays don’t count as business days, and many clocks start only once the file is accepted as complete. Published observed data shows how far real timelines can sit from the legal clocks:
- Brazil. In 196 contract-research-managed oncology trials, ANVISA’s mean time to final approval fell from 341 calendar days in 2013 to 90 days in 2023. The national ethics commission (CONEP) fell from 164 to 141 days. For May 2022 to December 2023, the means were 99 days (ANVISA) and 172 days (CONEP) (Giacomazzi et al., JCO Global Oncology, 2026). The study predates the review deadlines of Law 14,874.
- Region. A 2026 review reported median trial start-up times of about 2.8 months in Mexico, 4.5 months in Argentina, 4 to 7 months in Brazil, 4.6 months in Chile, 7 months in Colombia and up to 9 months in Peru (Zavaleta-Monestel et al., Cureus, 2026, citing oncology literature). Definitions of “start-up” differ between studies, so treat these as context, not as a plan. They are not comparable with the review order in the country table or with our synopsis-to-first-patient figures.
- Industry. The Tufts CSDD benchmark found an average of 31.4 weeks from site identification to completed start-up, with repeat sites 9.9 weeks faster than new ones (Tufts CSDD, 2018).
First site vs all sites. Check whether a benchmark measures one site, the first site activated or all planned sites. In a multicenter study, each site runs its own contract and initiation, and its own ethics approval where no central committee covers it. Plan around the sites you need to meet your recruitment target, not only the first.
What slows activation, and how to prevent it
| What slows it | Evidence | How to prevent it |
|---|---|---|
| A protocol that keeps changing | 76% of protocols in phases 1 to 4 have at least one amendment, with a mean of 3.3 (Tufts CSDD 2024, as cited by IQVIA). A change after translation may mean updated translations and, after submission, an amendment. | Freeze the protocol, consent form and brochure before translation starts. |
| Questions from the ethics committee or regulator | One round added about 3 to 6 weeks in our plans. Some legal clocks stop while the sponsor answers (Panama Decree 21, Art. 45, for ethics review; Brazil Law 14,874 lets ethics queries suspend the clock for up to 20 business days, as summarized by PSI CRO, 2024). | Answer within days, not weeks. Have the scientific owner on call during review. |
| A late insurance certificate | In one of our plans, a late policy forced a consent-form update and ethics resubmission, adding about 2 months. | Start the broker as soon as the site and investigator are chosen. |
| New sites with no track record | Repeat sites were 9.9 weeks faster in the Tufts benchmark. | Prefer sites that have run a similar study. |
| Site type and start-up capacity | In WCG’s 2025 survey of mostly US sites, 54% of independent sites reported they can start studies in under 60 days, against 9% of academic centers, community hospitals, health systems and site networks (WCG Site Challenges Report 2025). | Ask each site for its contract, budget and ethics calendar at selection. |
| Contract and budget negotiation | ACRP lists budget negotiations among the common causes of start-up delay, with bureaucracy, training and local approvals (ACRP sponsored article, 2025). | Send the contract template and budget with the feasibility package and negotiate during review. |
| Import permits and inspections | 5 weeks to 3 months in our plans; the longer end when the authority inspects the device. | Name the importer of record early and file as soon as the country allows. |
| Year-end holidays | In our experience, committees and hospitals slow down; our longest translation ran over the holidays. | Confirm translator availability and committee meeting dates before planning a December submission. |
Insurance: why it comes later than sponsors expect
Many countries in the region ask for proof of clinical trial insurance in the ethics or regulatory file, and some ask for a locally issued policy. Our country-by-country insurance guide (linked below) has the details. Insurers and brokers usually won’t issue a policy until they have:
- the full protocol (not only the synopsis),
- the countries, sites and principal investigators,
- the number of participants and the study duration, and
- the investigator’s brochure or device information.
So the realistic order is: final protocol → site and investigator selected → insurance quote and policy → certificate translated → ethics submission. If the certificate arrives after the ethics submission, the committee may need a second look. In one of our recent plans, a late policy meant translation, a consent-form update and an ethics resubmission, which added about 2 months.
For the details, read What insurers need to quote clinical trial insurance and Clinical trial liability insurance in Latin America: requirements by country.
Site activation readiness checklist
Use this as a planning checklist, then confirm the required documents and versions for each country, committee and study.
Before site selection (phase 2)
– ☐ Protocol synopsis
– ☐ Target countries and number of sites
– ☐ Confidentiality agreement template
– ☐ Feasibility questionnaire
Translation inputs (phases 1 and 3): schedule each document as soon as its final source version exists
– ☐ Final protocol (version and date)
– ☐ Investigator’s brochure, or device instructions for use and technical summary
– ☐ Informed consent form (master version)
– ☐ Case report forms
– ☐ Product labels
Submission package (phase 4)
– ☐ Country and ethics committee application forms
– ☐ Local-language consent form
– ☐ Investigator CVs and Good Clinical Practice certificates
– ☐ Site letters (acceptance, facilities)
– ☐ Product quality certificates
– ☐ Insurance certificate (phase 5)
– ☐ Signed contract, where the country asks for it (Ecuador, for example)
Before the first patient (phases 7 to 9)
– ☐ Ethics approval and every regulator approval, registration or notice the country requires
– ☐ Signed contract and budget
– ☐ Product imported, released and stored at the site
– ☐ Data system access and training complete
– ☐ Site initiation visit done
– ☐ Sponsor activation letter issued
Glossary
- Site activation: the point when a site has its approvals, contract, insurance, product and trained staff, and the sponsor authorizes it to enroll.
- Synopsis: a short summary of the study design, used to start feasibility.
- Ethics committee (EC): the independent committee that reviews the study for participant protection. Called a CEI, CEC or CEP in some countries.
- Regulator: the national health authority (for example ANVISA, COFEPRIS, INVIMA, ANMAT, ISP, MINSA).
- Business days: working days, excluding weekends and public holidays.
- Importer of record: the entity responsible for the import declaration and import obligations; local eligibility rules apply.
- Site initiation visit (SIV): the visit that trains the site team on the protocol before enrollment.
- Good Clinical Practice (GCP): the international quality standard for running clinical trials.
Frequently asked questions
Why can’t you quote insurance for us yet?
A broker usually needs the full protocol, the sites, the investigators and the number of participants to give a firm quote. With only a synopsis, that information doesn’t exist yet. In a recent plan, the policy was issued about 6 weeks after the site was chosen.
How long until the first patient?
In our recent plans, about 8 to 9 months from a protocol synopsis in the quickest-review countries, and about 4.5 to 6 months once the protocol was final. Countries where the regulator reviews after the ethics committee, or has a longer clock, add about 1 to 4 months, more if there are questions.
Can the phases run at the same time?
Yes, and they should. Site selection can start from the synopsis. Translation, the submission package, insurance, the contract and the import paperwork overlap. What can’t start early is the review: the ethics committee and the regulator need the final, translated documents. In some countries the two reviews then run at the same time (see the country table).
What makes timelines slip?
In our experience: a protocol that keeps changing, a late insurance certificate, a round of questions from the ethics committee or regulator, and the year-end holidays, when committees and hospitals slow down.
Is this different for drugs and devices?
The phases are the same. Durations can differ where a regulator has a drug-specific review or where a device needs an import or inspection step, as noted in the country notes.
Is there an outside benchmark?
A 2018 Tufts Center for the Study of Drug Development benchmark reported an average of 31.4 weeks from site identification to completed study start-up. Repeat sites took 9.9 weeks less than new ones (Tufts CSDD, 2018). It measures a different span than synopsis to first patient, so treat it as context.
What is the difference between site activation and first patient?
Activation means the site is authorized and ready to enroll. The first patient is a later milestone; define it in your plan (first consent, first enrollment or first treatment). In our plans, the time from site initiation to the first patient ranged from about 1 to 10 weeks.
Do I need a separate ethics approval for every site?
It depends on the country and the hospital. In our experience, some countries use a national or central committee and others require the hospital’s own committee. Brazil’s Law 14,874 introduced a single committee for multicenter studies (as described by Giacomazzi et al., 2026). We confirm this per country and site.
Which country is fastest?
In our recent plans, the quickest pathways were Panama, El Salvador and Chile, where ethics and regulatory approval of a complete submission took about 1 to 3 months. Our Chile figure is from a device study; drug trials there also need ISP authorization. Costa Rica’s published clocks are also short (see the country table). The fastest country for your study also depends on whether its sites can enroll your patients.
What can I do this week to save time?
Send the synopsis so the site search can start. Freeze the protocol before translation. Line up a broker. Decide who will be the importer of record.
Get a timeline for your study
Send us your protocol synopsis and the countries you are considering. We will send back a study-specific Gantt chart with every phase above, who owns it and what can run in parallel. Contact bioaccess®.
Related reading: Parallel review in Panama and El Salvador · Costa Rica activation calendar · INVIMA approval timeline in Colombia · Importer of record for multi-country trials · Importing investigational drugs and devices · US vs Canada vs Latin America for first-in-human · Clinical trial budget by country, line by line
Sources
- Panama: Executive Decree No. 21 of 23 April 2026, Gaceta Oficial 30510-C, Arts. 44, 45, 86, 88 to 92 and 95.
- Brazil, Mexico and Peru: NIH ClinRegs country profiles, “Timeline of Review” sections (clinregs.niaid.nih.gov), checked October 2026.
- Colombia: INVIMA, ASS-RSA-GU039 guide for the evaluation and follow-up of research protocols, version 6 (2026), sections 3.1 and 3.5.
- Argentina: ANMAT Disposition 7516/2025, Annex III, points 1.2.4 and 1.2.5.
- Chile: ISP Exempt Resolution 5161 (Ley Chile); InvestChile pharmaceutical industry e-book.
- Costa Rica: CONIS procedure for registering interventional and observational protocols (2025); CCSS memo CENDEISSS-AB-0115-2024.
- Dominican Republic: CONABIOS Manual of Operating Rules and Procedures V2 (2025); Provision 004-A-2004.
- Ecuador: ARCSA, “Autorización de ensayos clínicos” (controlsanitario.gob.ec); Ministerial Agreement 00069-2024.
- Guatemala: Ministerial Agreement 206-2021 (MSPAS).
- Uruguay: gub.uy procedure “Registro / Autorización de proyectos de investigación en seres humanos”.
- El Salvador: bioaccess® experience (no official clock cited).
- Tufts CSDD press release, 7 March 2018.
- bioaccess® study timelines (Gantt charts) for drug and device studies in Panama, El Salvador, Chile and Colombia, 2022 to 2026, de-identified.
- Giacomazzi J, et al. “Decade of Progress: Ethical and Regulatory Approval Timelines for Cancer Clinical Trials in Brazil.” JCO Global Oncology 12, e2600138 (2026).
- Zavaleta-Monestel E, et al. “Reframing Clinical Research in Latin America: Implications of Underrepresentation for Health Systems and Global Evidence.” Cureus (2026), PMC12959233.
- IQVIA, “Accelerating Study Start-up” insight brief (citing Tufts CSDD 2024 protocol amendment data).
- WCG, Site Challenges Report 2025.
- PSI CRO, “What to Know About Brazil’s New Clinical Research Law” (2024).
- ACRP, “Overcoming Study Start-Up Delays: Best Practices for Research Sites” (7 May 2025).