Clinical trials · Brazil
Clinical trial insurance in Brazil
Running a study in Brazil? Local regulation requires guaranteed assistance and indemnification to participants. GVM structures the compliant coverage — stand-alone or tied to your global master program.
- São Paulo, Brazil
- Service in EN · DE · ES · PT
- SUSEP-registered brokerage
- 60k+ participants protected
Brazil is one of the largest clinical research markets in Latin America — and one of the most regulated. Sponsors and CROs running a study here must guarantee coverage to participants, arranged with a local insurer. That is what we structure.
Why a local policy is required
A regulatory duty
The Brazilian ethics system (CEP/CONEP, Resolution CNS 466/2012), Brazil's clinical-research framework (Lei 14.874/2024) and ANVISA (RDC 9/2015) require the sponsor to guarantee assistance and indemnification to participants for research-related harm.
Local, admitted coverage
Brazil is a non-admitted market: the coverage must sit with a SUSEP-authorized insurer. A policy issued abroad generally cannot respond to a Brazilian claim.
Sized to the protocol
Coverage is dimensioned by study phase, number of subjects, duration and protocol design — not a one-size template.
How we help sponsors and CROs
Stand-alone policies
For a single study, structured to your protocol and compliant with Brazilian regulation.
Global master programs
Policies tied to a worldwide program, with the local admitted issuance Brazil requires.
Sponsor & CRO coordination
We coordinate the local placement with your global teams, insurers and CRO — in your language.
Reinsurance capacity
For large or complex programs, we source national and international reinsurance capacity.
Track record
- 60k+
- clinical-trial participants protected
- R$ 200M+
- insured capital under management
- 3 continents
- policies across the Americas, Asia and Africa
Frequently asked questions
Is clinical trial insurance mandatory in Brazil?
Guaranteeing assistance and indemnification to participants for trial-related harm is a requirement of the Brazilian framework (Lei 14.874/2024, the CEP/CONEP ethics system and ANVISA). Insurance is the usual way to meet it, and we structure it according to the protocol.
Do you issue stand-alone policies or only global programs?
Both. We arrange stand-alone policies for a specific study and policies tied to global master programs, with the local issuance Brazilian regulation requires.
Can a foreign (master) policy cover the Brazilian study?
Generally not on its own. Brazil requires a locally admitted policy; the master program is coordinated with a Brazilian-admitted insurer, often via reinsurance (fronting).
How is the coverage sized?
By study phase, number of participants, duration and protocol design. Send us the protocol summary and we structure the coverage and the quote.
In which languages do you work?
English, German, Spanish and Portuguese — both in the technical structuring and in coordination with your global teams.
How do we start?
Contact GVM with a summary of the study. We structure the compliant local coverage and a quote, with no obligation.
Let's structure your Brazil coverage
Send us the study and the local exposure. We'll come back with the compliant structure and a quote — no obligation.