Conducting Clinical Trials

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 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.

Conducting Clinical Trials

Conducting Clinical Trials in Brazil – Cohortias the CRO the LATAM

Brazil has been a popular destination for conducting clinical trials due to its large population, diverse gene pool, and favorable regulatory environment.

In recent years, the Brazilian government has implemented several initiatives to further promote the country as a hub for clinical research.

In this blog, we will explore the current landscape of clinical trials in Brazil and the regulatory framework that governs them.

Clinical trials are essential for testing the safety and efficacy of new drugs and medical devices before they are approved for use in patients.

In Brazil, clinical trials are regulated by the Brazilian Health Regulatory Agency (ANVISA) and the National Commission for Ethics in Research (CONEP).

ANVISA is responsible for ensuring that the drugs and medical devices used in clinical trials meet the necessary safety and efficacy standards, while CONEP ensures that the ethical standards for research are met.

In recent years, Brazil has made significant progress in streamlining the regulatory process for clinical trials.

In 2019, ANVISA implemented new regulations that simplified the requirements for clinical trial applications, reduced the review time for clinical trial protocols, and established clear guidelines for post-market surveillance.

These changes have made it easier and faster for sponsors to obtain approval for clinical trials in Brazil.

Another factor that makes Brazil an attractive destination for clinical trials is its large and diverse population.

Brazil is the fifth most populous country in the world, with a population of over 210 million people.

This large population provides a diverse gene pool for clinical trials, which is important for testing the safety and efficacy of new drugs and medical devices.

In addition, Brazil has a well-established healthcare infrastructure that includes both public and private healthcare systems.

Conducting clinical trials

Conducting Clinical Trials

This infrastructure provides access to a large pool of potential patients for clinical trials. The Brazilian healthcare system is also known for providing high-quality medical care, which is essential for ensuring the safety and well-being of clinical trial participants.

The Brazilian government has also implemented several initiatives to promote clinical research in the country.

In 2017, the Brazilian Ministry of Health launched the National Clinical Research Network (RNPC), which aims to promote the development of clinical research in the country.

The RNPC provides support and funding for clinical research projects and facilitates collaboration between researchers, healthcare professionals, and industry sponsors.

Despite the many advantages of conducting clinical trials in Brazil, there are also some challenges that sponsors should be aware of.

One of the main challenges is the language barrier.

Portuguese is the official language of Brazil, and many Brazilian healthcare professionals and patients may not speak English.

This can make it difficult for sponsors to communicate with potential study participants and healthcare professionals.

Another challenge is the high cost of conducting clinical trials in Brazil.

While the cost of living in Brazil is generally lower than in many developed countries, the cost of conducting clinical trials can still be high due to the complex regulatory environment and the need to navigate multiple layers of bureaucracy.

Sponsors should be prepared to invest significant resources in order to conduct successful clinical trials in Brazil.

In conclusion, Brazil is a promising destination for conducting clinical trials, with its large and diverse population, well-established healthcare infrastructure, and favorable regulatory environment.

The recent regulatory changes and government initiatives have further strengthened the clinical research landscape in the South American country.

However, sponsors should also be aware of the challenges involved in conducting clinical trials in Brazil, such as the language barrier and high costs.

With careful planning and preparation, sponsors can overcome these challenges and conduct successful clinical trials in Brazil.

Conducting Clinical Trials

Source: EFPIA

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.

Conducting Clinical Trials

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.
Conducting Clinical Trials

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.

Conducting Clinical Trials

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.

Conducting Clinical Trials

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

Conducting Clinical Trials

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.

Conducting Clinical Trials

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
Conducting Clinical Trials

The Cohortias Team

Conducting Clinical Trials

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

Conducting Clinical Trials

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