How to Obtain Clinical Trial Insurance for First-in-Human Trials in Latin America
A comprehensive guide for MedTech, Biopharma, and Radiopharma sponsors navigating clinical trial liability insurance requirements across Colombia, Chile, Peru, Argentina, Mexico, and beyond.
March 11, 2026
18
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
Clinical Trial Insurance
Latin America
First-in-Human
Regulatory
Risk Management
Colombia
MedTech
Why Clinical Trial Insurance Is Required
Before a clinical trial can begin in Latin America, sponsors must demonstrate that trial participants are financially protected in the event of an adverse event, injury, or complication arising from the study. This is not optional — it is a regulatory prerequisite enforced by national health authorities across the region.
Clinical trial liability insurance (also called clinical trial indemnity insurance) provides this protection. Without a valid policy in place, regulatory authorities will not approve the study protocol, and ethics committees will not grant approval to begin enrollment.
The rationale is straightforward: clinical investigations — especially first-in-human (FIH) studies — expose participants to unknown risks. Governments require sponsors to assume financial responsibility for these risks before exposing their citizens to experimental devices or therapies.
**⚠️ Do Not Delay Insurance Procurement**
Insurance is one of the most common causes of regulatory submission delays. Start the procurement process during protocol development — not after. A 4–8 week lead time is typical, and some countries require the policy to be in place before the regulatory dossier is submitted.
Country-by-Country Requirements
While the general principle is consistent across Latin America, each country has specific regulatory nuances:
| Country | Regulatory Authority | Insurance Requirement | Local Policy Required? |
|---|---|---|---|
| Colombia | INVIMA | Mandatory liability insurance required with regulatory submission. Policy must cover all enrolled subjects. | Yes — local policy through locally admitted insurer typically required |
| Chile | ISP / ANAMED | Clinical trial insurance required. Ethics committee reviews coverage terms before approval. | Yes — local "Seguro Ciencia Viva" policy required |
| Peru | DIGEMID / INS | Sponsor must provide proof of insurance or indemnity covering participant injuries. | Master policy generally accepted with local endorsement |
| Argentina | ANMAT | Insurance certificate required as part of the regulatory dossier. Local broker of record may be required. | Local broker of record required; local policy may be needed |
| Mexico | COFEPRIS | Liability insurance mandatory. Coverage must be issued or endorsed by a Mexican-admitted insurer or reinsurer. | Yes — locally admitted insurer or reinsurer endorsement required |
| Brazil | ANVISA / CONEP | Sponsor must guarantee free treatment for adverse events. Insurance strongly recommended and increasingly required. | Master policy generally accepted |
| El Salvador | DNM | Clinical trial liability insurance required as part of the clinical trial application to the Dirección Nacional de Medicamentos. | Master policy generally accepted |
| Panama | MINSA | Clinical trial liability insurance required before trial authorization is granted by the Ministry of Health. | Master policy generally accepted |
**📋 Master Policy vs. Local Policy**
Most sponsors need both a master/global policy AND local country-specific policies. The master policy provides overarching coverage, while local policies satisfy country-specific regulatory requirements. Colombia and Chile almost always require a local policy issued through a locally admitted insurer. Work with your broker — or let bioaccess® handle it — to determine the exact structure needed for your target countries.
What Clinical Trial Insurance Covers
A clinical trial liability insurance policy is designed to protect both trial participants and the sponsoring company. The coverage is specifically tailored to the unique risks of clinical research — it is not the same as general product liability insurance.
Typical Coverage Areas
- Bodily injury to trial participants resulting from the investigational device, drug, or procedure
- Adverse events — both anticipated (listed in the protocol) and unanticipated
- Medical treatment costs for injuries directly related to the clinical investigation
- Protocol deviations that result in participant harm
- Investigator errors during protocol execution (e.g., incorrect dosing, improper device deployment)
- Defense costs and legal fees in the event of a participant claim or lawsuit
- Death or permanent disability benefits as required by local regulations
- Compensation for lost wages or economic harm to injured participants
**📋 Key Distinction: Clinical Trial Insurance vs. Product Liability**
Standard product liability insurance typically excludes clinical investigation activities. You need a dedicated clinical trial liability (CTL) policy or a specific clinical trial endorsement. Do not assume your existing coverage extends to investigational use — verify with your broker.
What Does a Clinical Trial Insurance Policy Look Like?
Clinical trial insurance policies in Latin America are typically issued as a "Póliza de Responsabilidad Civil — Ensayos Clínicos" (Civil Liability Policy for Clinical Trials). These are specialized products offered by major international insurers with experience in the life sciences sector.
The most common underwriters include Chubb (through Federal Insurance Company) and Lloyd's of London (through syndicates such as Newline Syndicate 1218). In Chile, the product is marketed under a specific name: "Seguro Ciencia Viva" (Living Science Insurance).
Key elements of a clinical trial insurance policy include:
- Named insured — the sponsor company (and sometimes the CRO and principal investigator as additional insureds)
- Protocol title and protocol number — the policy is tied to a specific study
- Coverage territory — specific Latin American countries explicitly listed
- Coverage type: Responsabilidad Civil Extracontractual (Extracontractual Civil Liability) — covering harm to third parties (trial participants)
- Policy period — typically aligned with the trial duration, usually 1–2 years with renewal options
- Retroactive date — the earliest date from which claims arising from past acts are covered
- Deductibles (Deducible) — the amount the insured must pay before coverage kicks in
- Policy language — often issued in Spanish as required by local regulators and ethics committees
**📄 Policy Language Matters**
Many Latin American regulatory authorities and ethics committees require the insurance policy (or a certified translation) to be submitted in Spanish. Policies issued by Lloyd's or Chubb for LATAM territories are commonly issued in Spanish to meet this requirement. Ensure your broker understands this before the policy is drafted.
Typical Policy Limits and Costs
Understanding typical policy structures and costs helps sponsors budget accurately and avoid surprises during the procurement process. Here is real-world guidance based on bioaccess® experience:
Master / Global Policy Limits
| Coverage Type | Typical Limit |
|---|---|
| Per occurrence — Bodily Injury & Property Damage | $10,000,000 USD |
| Aggregate — Bodily Injury & Property Damage | $25,000,000 USD |
| Products / Completed Operations aggregate | $25,000,000 USD |
Local Country-Specific Policy Limits
In addition to (or instead of) the master policy, some countries require a local country-specific policy issued through a locally admitted insurer. These typically carry lower limits:
| Country | Typical Local Policy Limit | Estimated Premium (USD) | Notes |
|---|---|---|---|
| Chile | $1,000,000 USD | $5,000–$6,000 + ~19% local tax | "Seguro Ciencia Viva" product; local policy required by ISP/ANAMED |
| Colombia | $1,000,000 USD | $9,000–$11,000 (incl. taxes) | Issued through Lloyd's syndicates; local policy required by INVIMA |
| Other countries | $1,000,000 USD (typical) | Varies | Master policy may be accepted; check local requirements |
Important: Annual premiums vary significantly based on trial phase, number of enrolled subjects, device risk classification, and the number of countries involved. Medical device trials generally command lower premiums than drug trials due to lower perceived systemic risk.
**💰 Budget Planning Tip**
Most sponsors need both a master/global policy AND one or more local country-specific policies. Budget for the master policy premium plus $5,000–$11,000 per country that requires a local policy. Include local taxes (which can add 15–20%) in your financial projections. bioaccess® includes insurance cost estimates in our study budgets from Day 1.
How to Find a Specialized Insurance Broker
Clinical trial insurance is a niche product. Most general insurance agents and brokers are unfamiliar with the specific requirements of international clinical research. You need a broker who understands:
- The regulatory requirements of each Latin American country where you plan to conduct trials
- Clinical trial liability policy structures and coverage triggers
- How to coordinate international coverage across multiple jurisdictions
- The difference between indemnity-based and liability-based coverage
- The specific documentation required by ethics committees and regulatory authorities
bioaccess® helps connect sponsors with experienced brokers as part of our regulatory startup services. We have worked with multiple brokers over the years and can recommend partners based on your specific study design, risk profile, and target countries.
Recommended Brokers
The following brokers and underwriters specialize in clinical trial insurance and have experience with international studies, including Latin American territories:
**💡 bioaccess® Tip**
When contacting a broker, have the following ready: your study protocol (or synopsis), target countries, estimated number of subjects, device risk classification, and study duration. This allows the broker to provide an accurate quote quickly.
Key Considerations When Obtaining Coverage
Coverage Territory
Your policy must explicitly list every country where the trial will be conducted. A policy that covers "worldwide" may not satisfy local regulatory requirements — some countries (notably Argentina and Mexico) require the policy to be issued or endorsed by a locally admitted insurer.
- Verify that each target country is named in the coverage territory
- Check if the country requires a local broker of record or locally admitted policy
- Ensure the policy covers the full duration of the trial plus a tail period for late-emerging claims
- Confirm that the policy language (or a certified translation) meets the regulatory authority's requirements
Timeline to Obtain Coverage
Plan for 4–8 weeks from initial broker engagement to policy issuance. This timeline includes:
- Weeks 1–2: Broker engagement, submission of study details, and initial underwriting questions
- Weeks 2–4: Underwriter review, quote preparation, and coverage negotiation
- Weeks 4–6: Policy binding, certificate issuance, and any local endorsements required
- Weeks 6–8: Buffer for complex multi-country arrangements or novel device classifications
**⏰ Start Early — Insurance Delays Are Preventable**
The most common mistake sponsors make is treating insurance as a last-minute checkbox. In reality, it is a critical-path item that can delay your entire regulatory submission. Begin the process during protocol development, not after the protocol is finalized.
Key Insurance Terms You Should Know
Clinical trial insurance policies in Latin America are often issued in Spanish. Understanding the key terminology will help you review policies, communicate with local brokers, and ensure your coverage meets regulatory requirements:
| Spanish Term | English Translation | Definition |
|---|---|---|
| Póliza de Responsabilidad Civil | Civil Liability Policy | The core insurance product covering the sponsor's liability to trial participants |
| Ensayo Clínico | Clinical Trial | The clinical investigation covered by the policy |
| Seguro Ciencia Viva | Living Science Insurance | Chile's specific clinical trial insurance product name (used by ISP/ANAMED) |
| Valor Asegurado | Insured Value / Coverage Amount | The maximum amount the policy will pay per occurrence or in aggregate |
| Prima | Premium | The cost of the insurance policy — paid annually or for the policy period |
| Deducible | Deductible | The amount the insured must pay out-of-pocket before the policy responds |
| Vigencia | Coverage Period | The dates during which the policy is active and claims are covered |
| Tomador | Policyholder | The entity that purchases the policy (typically the sponsor or CRO) |
| Asegurado | Insured Party | The entity protected by the policy — may include sponsor, CRO, and investigators |
| Corredor | Insurance Broker | The intermediary who arranges the policy between the insured and the underwriter |
**💡 Why This Matters**
When reviewing a policy issued in Spanish — or when a local ethics committee asks questions about your coverage — knowing these terms ensures you can respond quickly and accurately. bioaccess® reviews all insurance documentation on behalf of our clients to verify compliance before submission.
How bioaccess® Can Help
Here's what most sponsors don't realize: bioaccess® doesn't just connect you with brokers — we obtain clinical trial insurance on your behalf. We handle the entire procurement process so you don't have to navigate it yourself.
Our team has secured clinical trial liability policies hundreds of times across Colombia, Chile, Peru, Argentina, Mexico, El Salvador, Panama, and beyond. For most sponsors, this is their first time — they've never procured international clinical trial insurance, don't know which brokers specialize in it, and aren't familiar with the country-specific requirements that can derail a submission if the policy language is wrong.
That's the bioaccess® difference. You hand off the entire insurance process to us, and we deliver a compliant policy — on time, meeting every local regulatory requirement — as part of your regulatory startup package.
Here's what that looks like in practice:
- We determine exact insurance requirements for each target country before the process begins
- We engage our network of specialized brokers on your behalf — no cold calls or research required from your team
- We manage the entire application, underwriting Q&A, and policy negotiation process
- We ensure coverage terms, policy language, and limits meet each regulatory authority's and ethics committee's specific requirements
- We coordinate timing so the policy is bound and certificates are issued before your regulatory submission deadline
- We prepare and submit the insurance documentation as part of the regulatory dossier in each country
**🤝 Why This Matters: Sponsors Save Weeks — and Avoid Costly Mistakes**
Insurance procurement is one of the most common causes of regulatory submission delays. Sponsors who try to navigate it independently often face weeks of back-and-forth with unfamiliar brokers, policies that don't meet local requirements, and last-minute scrambles that push back enrollment timelines. When bioaccess® handles it, the policy is right the first time — because we've done it hundreds of times before. It's built into our project management workflow from Day 1.
Frequently Asked Questions
Ready to Get Started?
If you're planning a first-in-human trial in Latin America, don't waste weeks navigating clinical trial insurance on your own. bioaccess® will obtain the policy for you — fully compliant, on time, and built into your regulatory startup package.
Book a meeting with our team to discuss your study requirements, target countries, and timeline. We'll take insurance off your plate so you can focus on your device and your data.
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