Mariana Bontorin, CEOFor Mariana Bontorin, CEO of Trial Brazil Insurance Broker, insurance decisions begin with understanding the people involved in clinical research. In many Latin American countries, a considerable part of the population works outside formal employment structures. As a result, some participants may not qualify for social security benefits such as sick pay, death benefits or disability pensions. These realities shape how participant protection is handled when creating insurance solutions.
Her background as a social assistant in a public institution gave her direct exposure to situations where healthcare challenges extended beyond medical treatment, including transportation difficulties, financial limitations and family support needs. That experience shaped her view of clinical research insurance as a form of practical support for participants and organizations.
Trial Brazil Insurance Broker reviews research protocols before insurance placement, looking at each study’s requirements and possible coverage gaps. In some cases, policies may cover only 70 to 80 percent of what a project actually needs. Early review helps clients understand coverage needs and costs before the insurance contract is finalized.
Her experience as an insurance inspector working with international carriers added technical depth to this perspective. She evaluates research protocols beyond compliance requirements, looking at how risks may develop during a study and how those situations could be managed if a claim occurs.
“We are focused on not only selling insurance, but at the same time, how we are going to regulate this insurance. We prepare our clients to receive insurance payouts and insurance companies to pay out." says Bontorin.
The difference is important in a market where some brokers focus mainly on issuing policies, while claim-related issues are addressed only after a problem occurs.
Risk Clarity before Pricing
Trial Brazil Insurance Broker focuses on helping clients understand coverage differences before selecting an insurance policy. Price remains an important factor, but the scope of coverage, exclusions and the type of study involved also influence the decision.
Each country presents different challenges because regulations and social security systems vary. In Brazil, insurance decisions are often influenced by cost, while differences between study types may receive less attention. However, a dermatological study and an oncology or vaccine trial involve very different levels of risk, requiring different insurance considerations.
The process also depends on insurer evaluation. Insurers generally take around five business days to respond, and some studies require additional review. Surgical procedures, pediatric studies and early-stage research may involve greater uncertainty and additional discussions with insurers.
Both cases required careful review before insurers accepted the risks. Working with insurers early allowed the studies to move forward without unnecessary delays.
Claims processes also vary throughout Latin America. In Brazil, participants often begin with legal action before settlement discussions take place. In many other Latin American countries, agreements are more commonly reached before litigation begins.
Coverage Structure Before Study Activation
Clinical research timelines can also be affected by regulatory approvals. Studies may involve ethics committees, ANVISA, with some approval processes extending up to six months. Understanding these stages helps clients plan insurance decisions alongside the broader research timeline.
Cannabis and stem cell studies show how different factors can affect clinical research insurance placement. The cannabis study faced social stigma around the subject, while the stem cell study involved uncertainty as an early-stage trial for a degenerative disease.
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We are focused on not only selling insurance, but at the same time, how we are going to regulate this insurance. We prepare our clients to receive insurance payouts and insurance companies to pay out.
Both cases required careful review before insurers accepted the risks. Working with insurers early allowed the studies to move forward without unnecessary delays.
Toward More Defined Coverage Structures
As clinical research continues to expand, Bontorin believes insurance structures need to better reflect the responsibilities of each party involved in a study. Sponsors, CROs, laboratories and research centers contribute in different ways, but current insurance models often apply similar structures despite these variations.
Trial Brazil Insurance Broker is working on insurance structures that separate product liability from protocol execution, with coverage based on the responsibilities of each party involved in the study.
More defined coverage would create a stronger alignment between responsibility and execution, providing greater clarity if disputes arise. Clearer allocation of responsibility may also give judges a more consistent basis for assessing accountability within different parts of a study.
With the expansion of clinical research in Latin America, coverage models need to reflect the responsibilities involved in study execution. Current insurance structures are focused on the objective study rather than the specific roles and activities involved in carrying out the protocol. Clearer alignment between coverage and responsibility can provide greater transparency make it easier to determine accountability.
Choosing Insurance Brokerage for Clinical Research
Insurance is now an essential part of every clinical study. Sponsors, research institutions, and CROs work in markets where rules and insurer preferences can change quickly or slowly. A policy that appears sufficient on paper may fall short for trials involving pediatric surgery, vaccine development, new cancer treatments, or experimental therapies with unknown risks. In these situations, choosing the right broker is more important than just looking at price. Executives acquiring brokerage support should treat the decision less as a placement exercise and more as a test of whether the broker can support you through claims, unexpected delays, or regulatory reviews.
The central weakness in many buying processes is the habit of comparing premiums before comparing coverage. Clinical trial insurance sits at the intersection of civil liability, participant assistance, sponsor protection and country-specific rules. Latin American markets add another layer because social security systems, settlement practices and litigation paths differ by jurisdiction. A broker must be able to read a research protocol, identify probable and less obvious exposures, understand the insurer’s exclusions and explain how far the insured parties are protected. This is especially important when a study may be structured from one country while adverse events occur in another.
“Clinical research requires careful alignment between the contract, protocol duties and the roles of sponsor, CRO, research center, investigator and insurer.”
Price is important, but it should not be more important than finding the right coverage. For example, a dermatology study, a vaccine trial, and a stem-cell protocol each have different risk levels, so the insurance policy should match those differences. Management teams should look for quotes that clearly explain not just the cost, but also the scope, limits, exclusions, claim triggers, and what each policy means for the sponsor, CRO, site, and participant.
Good brokers help clear up any confusion before the policy is issued, not after a problem comes up.
“Trial Brazil Insurance Broker is a strong choice for executives who need specialized brokerage for clinical research insurance in trial planning.”
Speed also requires a realistic view of the insurance market. Insurers may decline risks, delay quotations or price coverage beyond the study budget. Some may be reluctant to accept pediatric studies or procedures involving surgical techniques. A qualified broker cannot remove every delay, but it can anticipate resistance, prepare the underwriting case and keep sponsors from scheduling a study around coverage that has not truly been secured. In markets where regulatory approval can take months, that discipline protects timelines without pressuring clients at the wrong stage.
The strongest brokerage partner also stays close to the claim logic. It should not disappear once the policy is sold. Clinical research requires careful alignment between the contract, protocol duties and the roles of sponsor, CRO, research center, investigator and insurer. That alignment is becoming more important as the market moves away from one-size-fits-all cover and toward policies that distinguish product risk from execution risk.
Trial Brazil Insurance Broker is a strong choice for executives that need specialized brokerage for clinical research insurance in Brazil and broader Latin American trial planning. Its work is grounded in protocol review, coverage comparison and civil liability placement for research projects, supported by experience in insurer risk assessment and Brazilian regulatory flow. Its service scope includes protection tied to participant injury, adverse events, medical and dental expenses, protocol deviations, confidentiality failures, cyber events, legal costs, compassionate use, expanded access and post-study treatment supply. That combination makes it especially relevant for sponsors, CROs and institutions that need disciplined coverage rather than the lowest available premium.
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Clinical Research Insurance Brokerage Services in Latin America Info
Q1
What Are Clinical Research Insurance Brokerage Services?
Clinical Research Insurance Brokerage Services help sponsors, contract research organizations, and research institutions obtain insurance coverage that meets regulatory, ethical, and contractual requirements for clinical studies. These services support participant protection, liability management, and compliance throughout every phase of clinical research while helping organizations navigate country-specific insurance obligations.
Q2
How Does Trial Brazil Insurance Broker Deliver Clinical Research Insurance Brokerage Services?
Trial Brazil Insurance Broker demonstrates the value of Clinical Research Insurance Brokerage Services through its exclusive focus on clinical research insurance. Founded in 2013, the company develops insurance solutions designed to protect research participants, investigators, institutions, and sponsors throughout the clinical trial process. Based in São Paulo, it specializes in coverage tailored to the regulatory and operational requirements of clinical studies conducted in Brazil.
Q3
What Should Organizations Look for When Choosing Clinical Research Insurance Brokerage Services?
When evaluating Clinical Research Insurance Brokerage Services, organizations should consider regulatory expertise, experience with multinational clinical studies, insurer relationships, claims support, and the ability to structure coverage that aligns with study protocols and local requirements. A specialized brokerage can help reduce administrative complexity while ensuring insurance documentation is available before study initiation.
Q4
Why Are Clinical Research Insurance Brokerage Services Important for Clinical Trials?
Effective Clinical Research Insurance Brokerage Services help organizations manage financial and legal risks while supporting compliance with ethics committees, regulatory authorities, and contractual obligations. Appropriate insurance protects research participants against trial-related injuries and helps sponsors avoid delays that could interrupt study timelines or regulatory approvals.
Q5
Why Is Trial Brazil Insurance Broker Recognized for Clinical Research Insurance Brokerage Services?
Trial Brazil Insurance Broker applies Clinical Research Insurance Brokerage Services through a specialized portfolio created specifically for clinical research. Its insurance programs provide coverage across all stages of the research process while addressing the needs of sponsors, investigators, and participating institutions. The company's long-standing specialization in clinical research insurance has established it as a dedicated provider within Brazil's life sciences sector.
Q6
How Are Clinical Research Insurance Brokerage Services Evolving Across Latin America?
As clinical research expands across Latin America, Clinical Research Insurance Brokerage Services are evolving to support multinational studies, increasingly complex regulatory frameworks, and growing expectations for participant protection. Specialized brokers now combine risk advisory, regulatory knowledge, and international insurance coordination to help life sciences organizations conduct research efficiently while maintaining compliance across multiple jurisdictions.
