Site Selection for Clinical Trials in 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.

Site Selection for Clinical Trials in Brazil

Site Selection for Clinical Trials in Brazil – Full Service CRO

Clinical trials serve as crucial milestones in the development of innovative medical treatments and interventions. As the global landscape of pharmaceutical and biotechnology industries expands, Brazil has emerged as a prominent destination for clinical research.

With its diverse patient population, skilled investigators, and supportive regulatory environment, Brazil offers a promising setting for conducting clinical trials. In this blog post, we delve into the intricacies of site selection for clinical trials in Brazil, exploring key considerations, benefits, challenges, and best practices.

Understanding Brazil’s Clinical Trial Landscape

Brazil has witnessed a significant growth in clinical research, positioning itself as a frontrunner in the global clinical trial arena. The Brazilian Health Regulatory Agency (ANVISA) governs the approval and conduct of clinical trials, ensuring compliance with international standards. Furthermore, the country boasts a robust healthcare infrastructure and experienced investigators, making Brazil an attractive choice for a wide spectrum of therapeutic areas.

Key Considerations for Site Selection

  1. Patient Diversity: Brazil’s rich ethnic diversity provides a unique opportunity for clinical trials seeking to capture a wide range of patient demographics. Sponsors should assess disease prevalence and demographic data to ensure an appropriate and representative patient pool.
  2. Regulatory Framework: Familiarizing oneself with ANVISA’s regulatory requirements, submission processes, and timelines is critical for the successful initiation of a clinical trial. Collaborating with regulatory experts well-versed in Brazil’s regulations is highly recommended.
  3. Investigator Expertise: Selecting skilled investigators with a strong understanding of international research standards and a proven track record is pivotal for effective trial execution.
  4. Infrastructure and Facilities: Evaluating the quality and accessibility of healthcare facilities, laboratories, and equipment is essential to ensure participant safety and data integrity.
  5. Logistics and Accessibility: Analyzing transportation networks, site locations, and communication infrastructure is crucial for streamlined monitoring, data collection, and patient recruitment.

Benefits of Conducting Clinical Trials in Brazil

  1. Diverse Patient Population: Brazil’s diverse population enhances the generalizability of trial results, making it an ideal location for studies aiming to demonstrate treatment efficacy across various demographics.
  2. Efficient Regulatory Process: ANVISA’s alignment with international guidelines expedites study approval, reducing overall trial timelines and enabling quicker study initiation.
  3. Cost-Effective Operations: Conducting clinical trials in Brazil can offer cost savings due to competitive operational expenses and reasonable pricing for clinical trial services.
  4. Experienced Investigators: The country boasts a pool of experienced investigators with a strong grasp of global research practices, thereby elevating the quality of trial conduct.
  5. Access to Untapped Markets: Brazil provides access to treatment-naive patient populations, offering valuable insights into treatment effects and facilitating placebo-controlled studies.

Site Selection for Clinical Trials in Brazil

Site Selection for Clinical Trials in Brazil

Site Selection for Clinical Trials in Brazil

Challenges and Mitigation Strategies

  1. Language and Cultural Differences: While English proficiency is common among researchers, language and cultural barriers may affect participant communication. Employing bilingual staff and translating study materials can alleviate this challenge.
  2. Cultural Sensitivity: Demonstrating cultural sensitivity and respect for local customs and beliefs is crucial for building participant trust, encouraging participation, and ensuring trial success.
  3. Logistical Complexities: Managing logistics across diverse sites demands meticulous planning. Engaging local contract research organizations (CROs) or site management organizations (SMOs) can facilitate efficient trial coordination.
  4. Data Quality Assurance: Implementing robust data management and monitoring processes is essential to maintain data accuracy and uphold the integrity of the trial.

Best Practices for Successful Site Selection

  1. Collaboration with Local Experts: Partnering with experienced local CROs or SMOs can provide valuable insights into Brazil’s clinical research landscape, regulatory requirements, and cultural nuances.
  2. Comprehensive Site Assessment: Conduct thorough evaluations of potential sites, considering patient population, investigator expertise, regulatory compliance, and facilities.
  3. Clear Communication Channels: Establish open and effective communication between sponsors, investigators, and sites to ensure alignment on study objectives, expectations, and timelines.
  4. Patient-Centric Approach: Prioritize participant comfort and convenience to enhance recruitment, retention, and overall trial success.
  5. Ethical Conduct: Adhering to ethical guidelines and international standards is essential to protect participant rights and maintain the ethical conduct of clinical trials.


Effective site selection for clinical trials in Brazil requires a comprehensive understanding of the country’s clinical research landscape, regulatory framework, and cultural intricacies. Brazil offers a range of advantages, including a diverse patient population, experienced investigators, and a regulatory environment aligned with global standards.

By thoughtfully considering key factors and implementing best practices, sponsors can navigate the complexities of site selection and orchestrate successful, high-quality clinical trials in Brazil. These endeavors not only contribute to scientific advancement but also foster improved patient care and healthcare progress.

Site Selection for Clinical Trials 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.

Site Selection for Clinical Trials 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.
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Phase II & III Trials

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- 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.
Site Selection for Clinical Trials 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.

Site Selection for Clinical Trials 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.

Site Selection for Clinical Trials 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
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  • Neurology
  • Respiratory
  • Oncology

Site Selection for Clinical Trials 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.

Site Selection for Clinical Trials 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
Site Selection for Clinical Trials in Brazil

The Cohortias Team

Site Selection for Clinical Trials 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

Site Selection for Clinical Trials in Brazil

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