regulation in Brazil

Clinical Trials in: Mexico, Argentina, Colombia and Brazil.

Locally-Based, Full Service CRO

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As a leading CRO in LATAM, we specialize in supporting clinical trials in Brazil and throughout the region. Our extensive experience and broad network of clinical sites enable us to execute trials with speed and efficiency, ensuring high patient recruitment and retention rates.

Cohortias the CRO of LATAM

Clinical trial regulation in Brazil

New clinical trial regulation in Brazil 2023 – Top CRO of Latin America

Clinical trial regulation in Brazil is set to undergo significant changes in 2023, with the implementation of new rules that aim to improve the quality of clinical trials conducted in the country.

These changes come as part of a wider effort by the Brazilian government to modernize its healthcare system and strengthen its position as a leader in the field of clinical research.

The new regulations, which were announced in 2019, will come into effect on April 23, 2023. 

They will replace the existing regulations, which have been in place since 2013.

The new rules are intended to streamline the regulatory process for clinical trials in Brazil, while also improving the quality of data generated by these trials.

One of the key changes introduced by the new regulations is the requirement for sponsors to provide more detailed information about their clinical trials.

Sponsors will need to provide a detailed protocol for their trials, including information on the study design, endpoints, and statistical methods.

They will also need to provide a detailed risk management plan, which outlines how they will identify, evaluate, and mitigate risks associated with their trials.

In addition, the new regulations will require sponsors to provide more information on the informed consent process for clinical trial participants.

This will include information on the nature of the trial, the risks and benefits of participation, and the participant’s right to withdraw from the trial at any time.

Another important change introduced by the new regulations is the requirement for sponsors to conduct clinical trials in compliance with international standards for good clinical practice (GCP).

This includes the use of standardized study procedures, the training of study staff, and the implementation of quality control measures to ensure that data generated by the trial is accurate and reliable.

The regulation in Brazil also introduce stricter rules around the conduct of clinical trials involving vulnerable populations, such as children and pregnant women.

regulation in Brazil

Clinical trial regulation in Brazil

Sponsors will be required to obtain explicit consent from the parents or legal guardians of children participating in clinical trials, and from pregnant women, who will need to be informed of the risks and benefits of participation in the trial.

The implementation of the new regulations is expected to have a significant impact on the clinical trial landscape in Brazil.

The Brazilian government has been working to attract more clinical trials to the country in recent years, in a bid to improve access to new treatments for Brazilian patients and to boost the country’s position as a leader in clinical research.

The new regulations are expected to make Brazil a more attractive destination for clinical trials, by providing greater clarity and certainty around the regulatory process.

The requirement for sponsors to comply with international standards for GCP is likely to reassure international sponsors that their trials will be conducted to the highest standards of quality and safety.

At the same time, the new regulations are likely to lead to greater scrutiny of clinical trials conducted in Brazil, which could pose challenges for some sponsors.

Sponsors will need to ensure that their trials are conducted in compliance with the new rules, and that they are able to provide the detailed information and documentation required by the authorities.

Despite these challenges, the implementation of the new regulations is widely seen as a positive development for clinical research in Brazil.

The new rules are expected to improve the quality of clinical trials conducted in the country, which will benefit both patients and the wider healthcare system.

They will also help to strengthen Brazil’s position as a leader in the field of clinical research, and to attract more international sponsors to the country.

In conclusion, the new regulations governing clinical trials in Brazil represent an important step forward for the country’s healthcare system.

They are expected to improve the quality and safety of clinical trials conducted in the country, while also providing greater clarity and certainty for sponsors.

The implementation of these new rules is likely to have a significant impact on the clinical trial landscape in Brazil, and is a positive development for patients, sponsors, and the wider healthcare community.

Clinical trial regulation in Brazil

Welcome to Cohortias!

of Latin America

Simplify Your Clinical Trials with Our Expert Infrastructure in Latin America

Say goodbye to the complex, costly, and disorganized process of conducting clinical trials. Our infrastructure in Latin America streamlines the launch of studies and ensures adherence to international standards. Schedule a call with us today to discover the path to simplified clinical research in Latin America.

regulation in Brazil

Explore What We Are Doing Better

We define ourselves as a unique team, capable of blending our academic background with a global business mindset to bring the highest standard of quality and operational excellence into clinical research in Latin America.

Early Phase Trials

- First-in-Human Studies.
- Get to patients faster, no IND necessary.
- Valid data for FDA submission.

Rescue Studies

- Regain lost time and boost patient recruitment.
- We work alongside Global CROs to get studies back on track.
- More than 200 sites available.

Phase II & III Trials

- Full-Service Clinical Outsourcing.
- Proven infrastructure that can handle any trial.
- Local Regulatory Experts
- Wide network of sites and physicians.

Medical Devices

- A fast-track platform that will meet your timeline.
- We take care of everything, from shipping requirements all the way to data collection.
regulation in Brazil

Full Service CRO in LATAM

Outsourcing Clinical Trials to Latin America

Unlock the advantages and opportunities of outsourcing clinical trials to Latin America. Diverse patient population, streamlined regulations, and cost-effectiveness

Lower Operating Costs

From lower labor costs to lower costs for rent, utilities, and equipment, you can save money on your clinical trial budget while still ensuring the quality of your trial

Access to Emerging Markets

Latin America offers access to emerging markets, providing an opportunity for pharmaceutical companies to expand their reach and reach new patient populations.

regulation in Brazil

Cohortias is redefining Clinical Research in Latin America

We are committed to become leaders in providing clinical research services in Latin America. Here at Cohortias, we combine our academic roots, proven experience and a large pool of patients from an extensive network of sites.

Our main purpose is to deliver high quality data.

regulation in Brazil

Clinical Research in Latin America

Cohortias has built an extensive and highly reputable network of clinical sites which can access patients in a timely manner and operate within a standard-of-care comparable to the U.S. healthcare system.


  • Site Management

  • Data Management

  • Site Selection

  • Regulatory Submissions

  • Clinical Monitoring

  • Protocol Development


Beta Trials Platform

  • First-in-human studies

Medical Devices

  • Pilot and Pivotal Device Studies

Phases I – III

  • We partner with our clients to bring their products in a fast and efficient manner to the market with the highest quality standards


  • Diabetes/Metabolic Syndromes
  • Infectious Diseases
  • Cardiovascular
  • Neurology
  • Respiratory
  • Oncology

regulation in Brazil

Clinical Research in Latin America

Academic Leadership and Extensive Clinical Site Network for Efficient Clinical Trials

  • Our peer-to-peer management approach guarantees high patient recruitment and retention in any clinical trial

High Speed Execution

  • We offer the quickest start-up times in each country.
  • Efficient Clinical Site Selection and Contracting.
  • Benefit from our extensive network of clinical sites and streamlined contracting process.

Operational Excellence

  • Proven record of delivering rescue studies, we consistently exceed industry performance standards.
  • Our team provides efficient query resolution to keep your trial on track.

Business Insight and Flexibility

  • We offer innovative pricing models and short lines of communication to ensure maximum flexibility and cost-effectiveness.
  • At Cohortias, we prioritize  short lines of communication to ensure efficient collaboration.
  • Swift adaptation to changes in the trial landscape to keep your study on schedule.

regulation in Brazil

We provide our services with offices in:

Colombia &

Daniela Maresca
Daniela Maresca | Country Lead Argentina
Martín Hernández-Torre | CMO
Maritza Rojas | CRA II
Pedro Alvarez | Business Development Manager
Samantha Rodriguez Cohortias
Samantha Rdz. | Start-Up Manager
regulation in Brazil

The Cohortias Team

regulation in Brazil

As the largest South American Contract research Organization, we know the Advantages and Challenges Of the Region

Let Us Guide You Through The Latin American Clinical Research Landscape

regulation in Brazil

Network & Partnerships