Phase II Clinical Trials in Mexico

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 Mexico

Phase II Clinical Trials in Mexico – Full Servide CRO

Clinical trials play an indispensable role in advancing medical research, enabling the development of new and improved treatments that benefit millions worldwide. In Mexico, Phase II clinical trials form a pivotal stage in this process, bridging the gap between preclinical studies and large-scale Phase III trials.

These trials not only test the safety and efficacy of potential therapies but also contribute to strengthening Mexico’s healthcare ecosystem and fostering collaborations between research institutions, pharmaceutical companies, and regulatory authorities.

In this blog, we will delve into the significance of Phase II clinical trials in Mexico and explore how they have been instrumental in medical breakthroughs and improved patient care.

 Understanding Phase II Clinical Trials

Phase II clinical trials are a crucial step in the drug development process, aiming to evaluate the safety and efficacy of a new intervention in a relatively larger cohort of patients.

Typically involving hundreds of participants, these trials focus on specific diseases or conditions and are often randomized and double-blinded to reduce bias. The main objectives of Phase II trials are to determine appropriate dosages, identify potential side effects, and assess the therapeutic efficacy of the investigational drug or treatment.

 Regulatory Framework and Ethical Considerations

In Mexico, the regulatory framework governing clinical trials is overseen by the Federal Commission for Protection against Sanitary Risk (COFEPRIS). Before commencing any clinical trial, researchers and pharmaceutical companies must obtain approval from COFEPRIS, ensuring that the study adheres to ethical guidelines and patient safety standards.

Moreover, Mexico has been aligning its regulations with international norms, which has attracted global sponsors to conduct Phase II trials in the country.

Advantages of Conducting Phase II Trials in Mexico

  1. Diverse Patient Population: Mexico’s rich cultural diversity results in a varied patient population, making it an ideal location to test interventions across different ethnicities and genetic backgrounds. This diversity enhances the generalizability of trial results and increases the chances of identifying subgroup responses.
  2. Cost-Effectiveness: Conducting clinical trials in Mexico can be more cost-effective than in some other countries, offering sponsors the opportunity to achieve significant savings without compromising the quality of research and patient care.
  3. Experienced Investigative Sites: Mexico has well-established clinical research sites and experienced investigators who have been actively involved in conducting Phase II trials across various therapeutic areas.
  4. Access to Untapped Markets: For global pharmaceutical companies, conducting Phase II trials in Mexico opens the door to an untapped market with significant growth potential.

Phase II Clinical Trials in Mexico

Phase II Clinical Trials in Mexico

Phase II Clinical Trials in Mexico

Examples of Successful Phase II Clinical Trials in Mexico

Over the years, several Phase II clinical trials in Mexico have yielded promising results, contributing to medical advancements and improved patient outcomes. Some noteworthy examples include:

a. Cancer Immunotherapy: Mexico has been actively involved in Phase II trials exploring novel cancer immunotherapies, leading to breakthroughs in treating certain types of cancer and improving survival rates.

b. Infectious Diseases: Clinical trials in Mexico have played a vital role in evaluating new vaccines and treatments for infectious diseases, including Zika and Dengue.

c. Neurological Disorders: Phase II trials investigating potential therapies for neurological disorders like Alzheimer’s disease and multiple sclerosis have shown encouraging results in Mexico.

Challenges and the Way Forward

While Mexico has made significant strides in facilitating Phase II clinical trials, challenges persist. Issues related to patient recruitment, regulatory complexities, and public awareness of clinical research remain areas of improvement. To overcome these challenges, collaborative efforts between stakeholders, streamlined regulatory processes, and community engagement initiatives are essential.


Phase II clinical trials are a cornerstone of medical research in Mexico, fostering innovation, improving patient care, and strengthening the country’s position in the global healthcare landscape.

By providing a platform for novel interventions to be rigorously tested, Mexico’s involvement in Phase II trials brings hope for more effective treatments, increased disease understanding, and ultimately, a healthier and brighter future for patients not only in Mexico but worldwide. As the country continues to invest in clinical research, it is poised to play an increasingly significant role in shaping the future of medicine.

Phase II Clinical Trials in Mexico

Source: Roche

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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 Mexico

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 Mexico

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 Mexico

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 Mexico

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 Mexico

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 Mexico

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 Mexico

The Cohortias Team

Phase II Clinical Trials in Mexico

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

Phase II Clinical Trials in Mexico

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