Clinical Investigation in Brazil

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

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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.

Clinical Investigation in Brazil

Clinical Investigation in Brazil – Clinical Trials in Latin America

Clinical investigation, also known as clinical research, is the systematic study of new drugs, medical devices, or other medical treatments in humans. It is a critical step in the process of developing new therapies, and plays an essential role in ensuring the safety and efficacy of medical products.

Brazil has emerged as a significant player in the global clinical research market, with a thriving pharmaceutical industry and a large pool of potential study participants. In this blog, we will explore the state of clinical investigation in Brazil, its regulatory environment, and the challenges and opportunities facing researchers in this dynamic and rapidly evolving field.

Overview of Clinical Investigation in Brazil

Brazil is the largest country in South America, with a population of over 210 million people. It has a highly developed healthcare system, with both public and private healthcare providers.

Brazil’s pharmaceutical industry is also well-established, with a large number of domestic and international companies operating in the country. Brazil’s growing economy, large population, and advanced healthcare system have made it an attractive destination for clinical research.

Clinical investigation in Brazil is regulated by the National Health Surveillance Agency (ANVISA), which is responsible for overseeing all clinical trials conducted in the country.

ANVISA was established in 1999 and is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), a global organization that sets standards for the development and registration of pharmaceuticals.

In Brazil, clinical research is typically conducted in university hospitals, research centers, and private clinics. Brazil has a large pool of potential study participants, which includes both healthy volunteers and patients with a variety of medical conditions.

Brazil’s diverse population, which includes individuals of European, African, and indigenous ancestry, also makes it an attractive location for genetic and pharmacogenetic studies.

Clinical Investigation in Brazil

Clinical Investigation in Brazil

Regulatory Environment for Clinical Investigation in Brazil

ANVISA has established a rigorous regulatory framework for clinical research in Brazil, which is designed to ensure the safety and well-being of study participants. All clinical trials in Brazil must be approved by ANVISA before they can begin, and must adhere to the guidelines set forth by the International Conference on Harmonisation (ICH) and the Declaration of Helsinki.

To obtain approval for a clinical trial in Brazil, the study sponsor must submit a comprehensive study protocol to ANVISA, which outlines the study design, inclusion and exclusion criteria, and safety monitoring plan. The sponsor must also provide evidence of the safety and efficacy of the investigational product, as well as proof of its manufacturing quality and consistency.

Once the study protocol has been approved by ANVISA, the study can begin recruitment of study participants. All participants in clinical trials in Brazil must provide informed consent before they can participate in the study, and must be fully informed of the risks and benefits of the investigational product.

Challenges and Opportunities Facing Clinical Investigators in Brazil

While Brazil offers many advantages for clinical research, it also presents several challenges for investigators. One of the biggest challenges facing clinical investigators in Brazil is the lack of funding for research. While Brazil has a large number of highly skilled researchers and research institutions, many struggle to secure funding for their projects.

This can make it difficult to conduct large-scale clinical trials, particularly for rare or orphan diseases.

Another challenge facing clinical investigators in Brazil is the high cost of conducting clinical research. Brazil has a complex regulatory environment, which can make it time-consuming and expensive to obtain approval for clinical trials. Additionally, the high cost of healthcare in Brazil can make it difficult to recruit and retain study participants, particularly for studies that require long-term follow-up.

Despite these challenges, there are also many opportunities for clinical investigators in Brazil. Brazil’s large population and advanced healthcare system make it an ideal location for clinical research, particularly for studies involving rare or neglected diseases.

Brazil also has a highly skilled workforce of healthcare professionals and researchers, many of whom are experienced in clinical investigation. This expertise, combined with the country’s diverse population, allows for the exploration of various genetic and pharmacogenetic factors that may influence treatment response.

Clinical Investigation in Brazil

Source: Duke Clinical Research Institute

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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.

Clinical Investigation in Brazil

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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

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- 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.
Clinical Investigation 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.

Clinical Investigation 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.

Clinical Investigation 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

Clinical Investigation 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.

Clinical Investigation 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
Clinical Investigation in Brazil

The Cohortias Team

Clinical Investigation 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

Clinical Investigation in Brazil

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