Guidance in Clinical Research in Mexico

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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.

Guidance in Clinical Research in Mexico

Guidance in Clinical Research in Mexico – Clinical Trials Landscape in LATAM

Clinical research plays a pivotal role in advancing medical knowledge and improving healthcare outcomes. For Mexico, a country with a rich cultural heritage and a burgeoning healthcare industry, conducting clinical research presents both opportunities and challenges.

In this blog, we will explore the key aspects of guidance in clinical research in Mexico, including regulatory frameworks, ethical considerations, research infrastructure, and emerging trends. By understanding the nuances of clinical research in Mexico, researchers can navigate the landscape more effectively and contribute to the nation’s healthcare development.

Regulatory Framework for Clinical Research

Clinical research in Mexico is governed by several regulatory authorities. The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the primary regulatory body responsible for evaluating and approving clinical trials. Any clinical research involving drugs, medical devices, or biological products must obtain approval from COFEPRIS to ensure safety and efficacy.

In recent years, Mexico has made significant strides in harmonizing its regulations with international standards, making it more attractive for multinational research collaborations. Researchers must comply with Good Clinical Practices (GCP) guidelines and adhere to the ethical principles outlined in the Declaration of Helsinki to maintain research integrity and participant safety.

Ethical Considerations in Clinical Research

Protecting the rights and well-being of research participants is paramount in any clinical study. In Mexico, research ethics committees (RECs) play a crucial role in evaluating the ethical implications of research protocols. These committees consist of multidisciplinary experts who review and approve research proposals before the study can commence.

Respecting cultural diversity and ensuring informed consent are essential aspects of conducting ethical research in Mexico. Researchers must communicate effectively with potential participants, providing comprehensive information about the study in a language they understand. Additionally, involving local communities in the research process fosters trust and increases the likelihood of successful study recruitment.

Research Infrastructure and Capabilities

Mexico boasts a robust healthcare infrastructure with a diverse patient population, making it an ideal location for clinical research. Major cities are equipped with state-of-the-art medical facilities and research centers that collaborate with international partners. Institutions like the National Institutes of Health in Mexico (NIH Mexico) and the Mexican Institute of Social Security (IMSS) have been at the forefront of facilitating clinical trials across various therapeutic areas.

Despite this, there are challenges in terms of funding and resource allocation for clinical research. Public funding for research remains limited, and private sponsors often drive industry-sponsored trials. As a result, there is a need for increased collaboration between academia, government bodies, and industry to strengthen research capabilities and address pressing healthcare concerns.

Guidance in Clinical Research in Mexico

Guidance in Clinical Research in Mexico

Guidance in Clinical Research in Mexico

Emerging Trends in Clinical Research

The landscape of clinical research in Mexico is continuously evolving, driven by technological advancements and emerging healthcare trends. Some notable trends include:

  1. Personalized Medicine: The integration of genomic research and personalized medicine is gaining traction in Mexico. Tailoring treatments based on an individual’s genetic profile promises more effective and precise healthcare interventions.
  2. Telemedicine and Digital Health: The COVID-19 pandemic accelerated the adoption of telemedicine and digital health solutions in Mexico. Remote monitoring, teleconsultations, and health apps are reshaping healthcare delivery and offer new opportunities for clinical research.
  3. Rare Diseases and Orphan Drugs: Mexico is recognizing the importance of researching rare diseases and orphan drugs. Incentives and streamlined regulatory pathways are being developed to encourage research in these areas.
  4. Vaccines and Infectious Diseases: Given the country’s history with infectious diseases, there is ongoing research focusing on vaccine development and epidemiological studies.


Guidance in clinical research in Mexico involves navigating a complex landscape of regulations, ethics, infrastructure, and emerging trends. With a commitment to upholding ethical principles, collaborating with local experts, and embracing technological advancements, researchers can contribute to advancing medical knowledge and improving healthcare outcomes in Mexico. As the nation continues to grow its healthcare industry, clinical research will play a vital role in shaping the future of healthcare for its diverse population.

Guidance in Clinical Research in Mexico

Source: Roche

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Guidance in Clinical Research in Mexico

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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.

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Guidance in Clinical Research in Mexico

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Unlock the advantages and opportunities of outsourcing clinical trials to Latin America. Diverse patient population, streamlined regulations, and cost-effectiveness

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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

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Latin America offers access to emerging markets, providing an opportunity for pharmaceutical companies to expand their reach and reach new patient populations.

Guidance in Clinical Research 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.

Guidance in Clinical Research 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

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Beta Trials Platform

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Medical Devices

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Phases I – III

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  • Diabetes/Metabolic Syndromes
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Guidance in Clinical Research 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.

Guidance in Clinical Research 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
Guidance in Clinical Research in Mexico

The Cohortias Team

Guidance in Clinical Research in Mexico

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

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Guidance in Clinical Research in Mexico

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