Brazil's Clinical Trial Industry

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

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Brazil's Clinical Trial Industry
As a leading CRO in LATAM, we specialize in supporting clinical trials 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.

Brazil's Clinical Trial Industry

Brazil’s Clinical Trial Industry – Health Research in Colombia

Brazil has emerged as one of the most attractive locations for clinical trials in Latin America, thanks to a large patient population, a well-developed research infrastructure, and a favorable regulatory environment.

The country’s clinical trial industry has grown significantly over the past decade, and is now a key driver of innovation in the pharmaceutical industry.

In this blog post, we will explore the key features of Brazil’s clinical trial industry, its regulatory landscape, and the opportunities and challenges it presents for drug developers.

Overview of Brazil’s Clinical Trial Industry

Brazil’s clinical trial industry has experienced significant growth over the past decade, driven in part by the country’s large and diverse patient population, its well-developed research infrastructure, and its favorable regulatory environment. The country has a robust network of research institutions, hospitals, and clinics that offer state-of-the-art facilities for conducting clinical trials, as well as experienced investigators and research staff.

Brazil’s clinical trial industry is largely driven by the private sector, which accounts for the majority of investment in drug development studies. However, the government has also played an active role in promoting the industry, with initiatives aimed at attracting foreign investment, promoting innovation, and strengthening the country’s research infrastructure.

Regulatory Landscape

Brazil’s regulatory framework for clinical trials is overseen by the National Health Surveillance Agency (ANVISA), which is responsible for approving and regulating clinical trials in the country. The agency follows international guidelines, such as those set by the International Conference on Harmonisation (ICH), to ensure that clinical trials are conducted safely and ethically.

One of the key features of Brazil’s regulatory landscape is the expedited review process for clinical trial applications. ANVISA has established a fast-track review process for clinical trial applications, which allows for approval within 90 days for certain types of studies. This has helped to attract foreign investment and encourage drug developers to conduct trials in Brazil.

Another important aspect of Brazil’s regulatory landscape is the emphasis on patient safety. ANVISA requires that all clinical trials comply with international ethical standards, including informed consent and monitoring of adverse events. This helps to ensure that clinical trials are conducted in a safe and ethical manner, while also protecting the rights of patients who participate in these studies.

Brazil's Clinical Trial Industry

Brazil's Clinical Trial Industry

Brazil's Clinical Trial Industry

Opportunities and Challenges

Brazil’s clinical trial industry presents a number of opportunities for drug developers, including access to a large and diverse patient population, a supportive regulatory environment, and lower costs compared to other countries, such as the United States. In addition, Brazil’s geographic location makes it an attractive location for conducting clinical trials that involve patients from both North and South America.

However, there are also a number of challenges that drug developers must navigate when conducting clinical trials in Brazil. One of the biggest challenges is the need to navigate the country’s complex regulatory landscape, which can be difficult for foreign companies to navigate without the help of local experts. In addition, drug developers must also navigate the cultural differences and language barriers that can arise when conducting clinical trials in a foreign country.

Another challenge is the need to ensure that clinical trials are conducted in a safe and ethical manner, while also meeting the needs of patients who participate in these studies. This requires careful planning and execution, as well as a commitment to transparency and communication with patients and their families.


Brazil’s clinical trial industry presents a promising opportunity for drug developers looking to conduct research and bring new treatments to market. The country’s infrastructure for conducting clinical trials is well-developed, with experienced investigators and specialized research centers that offer state-of-the-art facilities. Moreover, the country’s large and diverse patient population offers drug developers access to a wide range of patient populations that can help to ensure the safety and efficacy of new treatments.

As Brazil continues to grow as a hub for clinical trials, it is important for drug developers to remain aware of the challenges and opportunities presented by the country’s regulatory landscape and patient population. By working with local experts and investing in careful planning and execution, drug developers can take advantage of Brazil’s growing clinical trial industry to bring new treatments to market and improve patient outcomes.

There are also opportunities for the Brazilian clinical trial industry to mature and grow further. For instance, there is a need to increase the participation of the public sector in clinical research to enhance the research infrastructure and capacity in the country. This would help to ensure that the necessary resources are available to conduct high-quality research that can lead to improved health outcomes for patients.

Additionally, there is an opportunity to focus on expanding clinical trials in new areas, such as precision medicine, immunotherapy, and gene therapies, which require specialized expertise and infrastructure. By doing so, Brazil can position itself as a leader in these emerging areas of drug development, while also improving access to innovative therapies for patients in need.

In conclusion, Brazil’s clinical trial industry has made significant strides over the past decade, and the country’s favorable regulatory environment, strong infrastructure, and large patient population offer opportunities for drug developers to conduct research and bring new treatments to market. While challenges remain, continued investment and collaboration between the public and private sectors can help to ensure that the Brazilian clinical trial industry continues to grow and mature, while also benefiting patients in Brazil and around the world.

Brazil's Clinical Trial Industry

Source: Duke Clinical Research Institute

Cohortias the CRO of LATAM

Clinical Trials 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.

Brazil's Clinical Trial Industry

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.
Brazil’s Clinical Trial Industry

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.

Brazil’s Clinical Trial Industry

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.

Brazil's Clinical Trial Industry

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

Brazil's Clinical Trial Industry

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.

Brazil's Clinical Trial Industry

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
Brazil’s Clinical Trial Industry

The Cohortias Team

Brazil's Clinical Trial Industry

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

Brazil's Clinical Trial Industry

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