CRO in Brazil,clinical trials

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

Locally-Based, Full Service CRO

Contact us today to learn more.

+ 0
Sites Throughout LATAM
+ 200
Patients in our network
+ 0
Conducted Studies
0 %
Lost-to-Follow Up rate
CRO in Brazil
Brazil is a large country with over 200 million inhabitants, making it the largest population in Latin America.

CRO in Brazil - Opportunities and challenges in Brazil.

Brazil is a large country with over 200 million inhabitants, making it the largest population in Latin America. Divided into five regions, the country is the sixth largest pharmaceutical market in the world where regulatory compliance for clinical trials is upheld by an experienced and qualified workforce.

At first glance, these figures could be attractive to pharmaceutical and biotechnology companies. However, regulatory frameworks in Brazil are restrictive.

The regulatory process to approve clinical trials in the country requires approval by two entities, an ethical approval by CONEP (Comissão Nacional de Éticaem Pesquisa/National Ethics Commission) and a regulatory approval by ANVISA (Agência Nacional de Vigilância Sanitária/National Agency of Health Surveillance). Additionally, clinical trials require two ethical approvals, one by CONEP (as previously mentioned), which grants approvals at the national level and one at the local level by the institutional Ethics Committee (IEC).

Both bodies have to approve the same package. For multicenter studies, a selected site is assigned as the coordinator site to get the first approval by its local IEC, before the site is approved by CONEP. Once the final approval is released by CONEP, each one of the remaining sites must also submit the study to obtain the approval from the local IEC. The timeframe for all these steps usually takes 90 days.

The sponsor is responsible to apply the package describing the study and related supplies, such as the medication, lab tubes and any equipment or medical devices to ANVISA’s evaluation. This application can be started after the first local ethics approval at the coordinator site. Bear in mind, the approval letter could take over 12 months to be released.

Combining the double ethics and regulatory approvals, the total lead time could easily exceed 12 or even 18 months. As a result, this long timeline usually forces trials in Brazil to start later than in their foreign counterparts.

In order to change this environment, ANVISA opened a public consultation in 2014 where over 600 suggestions were received. Multiple rounds of discussions took place throughout 2014 with local players, which brought about steady progress, from a regulatory standpoint.

Based on new rules and timelines released by ANVISA in March 2015, upon receipt of the Drug Clinical Development Dossier (DDCM), ANVISA has 90 days to evaluate it. If there is no response after receipt the clinical trial can be started after the relevant ethical approval by CONEP. It means that Tacit approval is applicable and valid for Phase III studies with small molecules.

For Clinical Developments of Biological Products (including vaccines) and Clinical Developments in Phase I or Phase II, the DDCM evaluation occurs within 180 days after receipt of DDCM by ANVISA and the clinical trial may be initiated only after approval by ANVISA. 

CRO in Brazil

Brazil is one of the largest and most populous countries in the world, with a growing healthcare industry and a large pool of potential participants for clinical trials. However, like many countries, Brazil also faces challenges when it comes to conducting clinical trials, including regulatory issues, lack of infrastructure, and socioeconomic disparities. In this blog, we will explore the opportunities and challenges facing clinical trials in Brazil.


  1. Large patient pool: Brazil has a large and diverse population, with over 200 million people. This means that there is a large potential pool of patients for clinical trials, particularly for diseases that are prevalent in Brazil, such as dengue fever and Chagas disease.
  2. Experienced researchers: Brazil has a well-established research community, with many experienced researchers in various fields. This expertise can be leveraged to conduct high-quality clinical trials.
  3. Lower costs: The cost of conducting clinical trials in Brazil is often lower than in other countries, due to lower labor costs and lower costs of living. This makes Brazil an attractive location for sponsors looking to conduct trials cost-effectively.
  4. Regulatory environment: The regulatory environment for clinical trials in Brazil has improved in recent years, with the creation of the Brazilian Health Regulatory Agency (ANVISA) and the National Council for Ethics in Research (CONEP). These agencies have made it easier for researchers to obtain regulatory approvals for clinical trials.


  1. Socioeconomic disparities: Brazil is a country with significant socioeconomic disparities, which can make it challenging to recruit patients for clinical trials. Many Brazilians live in poverty and lack access to healthcare, which can make it difficult for them to participate in trials.
  2. Infrastructure: While Brazil has a well-established research community, the country still lacks some of the necessary infrastructure for conducting clinical trials. This includes sufficient laboratory facilities and equipment, as well as trained staff to conduct and manage trials.
  3. Language barriers: While Portuguese is the official language of Brazil, many people in the country speak other languages, including indigenous languages. This can make it challenging to communicate with potential trial participants who do not speak Portuguese.
  4. Regulatory hurdles: While the regulatory environment for clinical trials in Brazil has improved, there are still challenges to obtaining regulatory approvals for trials. This includes navigating complex and sometimes conflicting regulations, as well as obtaining timely approvals from regulatory agencies.


Brazil presents a significant opportunity for clinical trials, with a large and diverse patient population and an experienced research community. However, there are also challenges to conducting trials in Brazil, including socioeconomic disparities, infrastructure gaps, language barriers, and regulatory hurdles. Despite these challenges, with the right investment and support, Brazil has the potential to become a key player in the global clinical trial landscape.

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.

CRO in Brazil,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.
CRO in Brazil,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.

CRO in Brazil,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.

CRO in Brazil,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

CRO in Brazil,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.

CRO in Brazil,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
CRO in Brazil,clinical trials

The Cohortias Team

CRO in Brazil,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

CRO in Brazil,clinical trials

Network & Partnerships