Clinical Trial Monitoring in Brazil

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

Locally-Based, Full Service CRO

Contact us today to learn more.

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Sites Throughout LATAM
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Clinical Trial Monitoring in Brazil
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 Trials in Brazil

Clinical Investigation

Clinical Trial Monitoring in Brazil – Clinical Trials in Latin America

Brazil has emerged as a prominent player in the global clinical research industry, with a rapidly growing healthcare system, a large and diverse patient population, and a favorable regulatory environment.

The country offers a range of advantages for clinical trial sponsors, including lower costs, faster recruitment times, and access to high-quality research infrastructure.

However, effective clinical trial monitoring in Brazil requires careful planning and execution, with attention to regulatory compliance, patient safety, and data integrity.

One of the key challenges in clinical trial monitoring in Brazil is compliance with regulatory requirements. Brazil’s regulatory framework for clinical trials is based on guidelines established by the National Health Surveillance Agency (ANVISA), which is responsible for ensuring that clinical trials meet rigorous ethical and safety standards.

Sponsors must obtain approval from ANVISA before conducting clinical trials in Brazil, and must comply with a range of requirements related to informed consent, data collection, and reporting adverse events.

To ensure compliance with regulatory requirements, sponsors can work with local investigators to develop robust protocols and standard operating procedures that meet ANVISA’s guidelines. Sponsors should also ensure that their clinical trial teams are trained in regulatory requirements and that they have access to experienced local regulatory consultants who can provide guidance on compliance issues.

Another key challenge in clinical trial monitoring in Brazil is ensuring patient safety. Clinical trials involve exposing patients to investigational drugs, which can carry risks. To minimize these risks, sponsors must ensure that clinical trial participants receive appropriate medical care and that adverse events are promptly reported and appropriately managed.

To address this challenge, sponsors can work with local investigators to establish clinical trial sites with experienced healthcare providers who are familiar with the management of adverse events.

Sponsors can also provide training to healthcare providers on the management of adverse events and ensure that all clinical trial participants have access to medical care 24/7.

Moreover, it is essential to address the lack of diversity in clinical trial participants in Brazil. Like many countries, Brazil has historically struggled with diversity in clinical trials, with underrepresented populations often excluded from participation.

Clinical Trial Monitoring in Brazil

Brazil's Clinical Trial Industry

To address this issue, sponsors can work with local advocacy groups to increase awareness about clinical trials and educate underrepresented communities about the benefits of participating in clinical trials.

Additionally, sponsors can work with local investigators to develop recruitment strategies that are culturally appropriate and sensitive to the needs of underrepresented communities.

This may involve translating study materials into local languages, conducting community outreach programs, and establishing partnerships with community organizations.

Another key challenge in clinical trial monitoring in Brazil is the need for robust data management systems. Accurate data collection and analysis are critical for ensuring the integrity of study results and protecting the safety of study participants.

To address this challenge, sponsors can work with local investigators to develop standardized data collection protocols and invest in data management systems that meet regulatory requirements.

Furthermore, the Brazilian government can play a crucial role in promoting clinical research by investing in healthcare infrastructure and providing funding for research and development. This could include supporting the development of research centers and hospitals in rural and remote areas, where access to healthcare is limited.

Moreover, the government can consider offering tax incentives and other financial incentives to attract foreign investment in the healthcare sector. These incentives can help to create a more favorable environment for clinical trial sponsors and encourage greater investment in research and development in the country.

In conclusion, clinical trial monitoring in Brazil is a critical component of the drug development process and plays a vital role in advancing medical research globally.

While there are challenges facing the healthcare system and the regulatory environment, Brazil remains an attractive destination for clinical trials due to its large and diverse population, high-quality healthcare system, and favorable regulatory environment.

By addressing the challenges and promoting collaboration between industry, academia, and government, Brazil can continue to play a leading role in clinical research in Latin America and beyond.

Clinical Trials in Brazil

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.

Clinical Trial Monitoring 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.
Clinical Trial Monitoring 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 Trial Monitoring 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 Trial Monitoring 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 Trial Monitoring 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 Trial Monitoring 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 Trial Monitoring in Brazil

The Cohortias Team

Clinical Trial Monitoring 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 Trial Monitoring in Brazil

Network & Partnerships