Phase II Clinical Trials 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.

Phase II Clinical Trials in Brazil

Phase II Clinical Trials in Brazil – Full Servide CRO

Clinical trials are the backbone of medical progress, enabling the discovery and development of novel treatments that can transform patient outcomes. In Brazil, Phase II clinical trials play a pivotal role in advancing medical research, bridging the gap between preclinical studies and larger Phase III trials.

These trials are instrumental in assessing the safety and efficacy of potential interventions, fostering collaborations between research institutions, pharmaceutical companies, and regulatory bodies. In this blog, we delve into the significance of Phase II clinical trials in Brazil and explore their impact on medical breakthroughs and advancements in patient care.

Understanding Phase II Clinical Trials

Phase II clinical trials represent a critical stage in drug development, involving a larger cohort of patients to evaluate the safety and efficacy of potential therapies. Typically enrolling hundreds of participants, these trials are often randomized and double-blinded to reduce bias. The primary objectives of Phase II trials include determining appropriate dosages, identifying potential side effects, and assessing the therapeutic effectiveness of the investigational drug or treatment.

Regulatory Landscape and Ethical Considerations

In Brazil, the regulatory oversight of clinical trials falls under the purview of the National Health Surveillance Agency (ANVISA). Before commencing any Phase II trial, researchers and pharmaceutical companies must obtain approval from ANVISA, ensuring that the study adheres to strict ethical guidelines and meets international standards of patient safety.

Brazil’s commitment to aligning its regulations with global norms has made it an attractive destination for conducting clinical trials.

Advantages of Conducting Phase II Trials in Brazil

  1. Diverse and Sizeable Patient Population: Brazil’s vast and ethnically diverse population provides a unique opportunity to evaluate treatment responses across various genetic backgrounds and demographics. This diversity enhances the generalizability of trial results, making them more applicable to broader patient populations.
  2. Highly Skilled Investigators and Research Facilities: Brazil boasts a network of well-established clinical research sites and experienced investigators who have been actively engaged in conducting Phase II trials across various therapeutic areas.
  3. Collaborative Research Environment: Brazil encourages collaboration between academia, industry, and healthcare providers, fostering an environment conducive to innovative research and efficient clinical trial execution.

d. Market Potential and Economic Viability: Conducting Phase II trials in Brazil allows international pharmaceutical companies to access a vast and growing market, along with the potential for cost savings in comparison to trials in some other regions.

Phase II Clinical Trials in Brazil

Phase II Clinical Trials in Brazil

Phase II Clinical Trials in Brazil

Success Stories of Phase II Clinical Trials in Brazil

Brazil has been at the forefront of numerous successful Phase II clinical trials, contributing to medical advancements and improved patient care. Some noteworthy examples include:

  1. Neglected Tropical Diseases: Clinical trials in Brazil have played a crucial role in evaluating potential treatments for neglected tropical diseases like Chagas disease and leishmaniasis, addressing public health challenges that disproportionately affect certain regions.
  2. Vaccines and Infectious Diseases: Brazil has been actively involved in Phase II trials testing novel vaccines and treatments for infectious diseases such as HIV, dengue, and COVID-19, contributing to global efforts to combat these health threats.
  3. Oncology: Phase II trials in Brazil have contributed to advancing cancer treatments, exploring novel therapies for different types of cancer and improving patient outcomes.

Challenges and Future Outlook

While Brazil has made significant strides in clinical research, challenges remain. Enhancing patient recruitment, addressing logistical issues, and reducing bureaucratic complexities are areas that require attention to optimize the conduct of Phase II trials. By addressing these challenges and fostering an environment that promotes research and innovation, Brazil can further strengthen its position as a key player in the global clinical trial landscape.


Phase II clinical trials are pivotal to Brazil’s medical landscape, fostering innovation, and driving advancements in patient care. By providing a platform for rigorous evaluation of potential interventions, Brazil contributes to the global mission of advancing medical science and improving healthcare outcomes.

As the country continues to invest in research infrastructure, regulatory harmonization, and collaboration between stakeholders, it stands poised to unlock the full potential of Phase II clinical trials, benefitting both its own population and patients around the world.

Phase II Clinical Trials in Brazil

Source: Duke Clinical Research Institute

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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.

Phase II 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.
- 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.
Phase II 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.

Phase II 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.

Phase II 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
  • Cardiovascular
  • Neurology
  • Respiratory
  • Oncology

Phase II 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.

Phase II 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
Phase II Clinical Trials in Brazil

The Cohortias Team

Phase II Clinical Trials in Brazil

As the largest South American Contract research Organization, we know the Advantages and Challenges Of the Region

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Phase II Clinical Trials in Brazil

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