Overview of 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.

Overview of Clinical Trials in Mexico

Overview of Clinical Trials in Mexico – Cohortias the CRO of LATAM

Clinical trials play a crucial role in advancing medical knowledge, improving patient care, and developing new treatments. Mexico, with its diverse population and growing healthcare infrastructure, has emerged as a significant hub for clinical research.

This blog post provides an overview of clinical trials in Mexico, highlighting the country’s regulatory framework, advantages, challenges, and future prospects.

Regulatory Framework

Mexico has a robust regulatory framework that governs clinical trials to ensure patient safety and data integrity. The Federal Commission for Protection against Sanitary Risks (COFEPRIS) is responsible for overseeing the approval and regulation of clinical trials.

Mexican regulations adhere to international standards, including Good Clinical Practice (GCP) guidelines. Collaborations with international regulatory bodies, such as the Food and Drug Administration (FDA) in the United States, have helped streamline the approval process.

Advantages of Conducting Clinical Trials in Mexico

Mexico offers several advantages for conducting clinical trials. Firstly, its diverse population represents a broad genetic and ethnic diversity, allowing researchers to gather data on various demographics. Secondly, the country’s relatively large patient pool enhances recruitment potential, leading to faster enrollment and completion of studies.

Additionally, Mexico’s healthcare infrastructure is continuously improving, with numerous specialized centers and hospitals equipped with modern facilities, making it an attractive destination for sponsors and researchers. Furthermore, the cost of conducting clinical trials in Mexico is often more affordable compared to other countries, without compromising on quality or data reliability.

Overview of Clinical Trials in Mexico

Overview of Clinical Trials in Mexico

Cohortias the CRO of LATAM

Overview of Clinical Trials in Mexico

Challenges and Mitigation

While Mexico presents numerous opportunities for clinical trials, it also faces certain challenges. One of the significant hurdles is patient recruitment, particularly in remote areas where access to healthcare and awareness of clinical trials may be limited.

To address this, collaborations with local healthcare providers, community outreach programs, and education initiatives can help increase participation. Language barriers can also pose challenges, as the majority of Mexicans speak Spanish. Translation services and bilingual staff can bridge this gap and ensure effective communication.

Another challenge is maintaining high-quality standards across research sites. Regular monitoring visits, investigator training, and adherence to GCP guidelines can help ensure data accuracy and integrity. Additionally, effective collaboration between sponsors, Contract Research Organizations (CROs), and local investigators is essential for successful trial execution.

Future Prospects

The future of clinical trials in Mexico looks promising. The Mexican government recognizes the importance of clinical research and has taken steps to attract investment and foster collaborations with international stakeholders.

Continued improvements in the regulatory framework, expedited approval processes, and increased funding for research and development initiatives will further enhance Mexico’s position as a preferred destination for clinical trials.

Moreover, emerging areas of research, such as genomics, personalized medicine, and rare diseases, present unique opportunities for collaboration between Mexican researchers and global partners. Leveraging Mexico’s diverse population and genetic makeup can contribute to the development of targeted therapies and precision medicine.


Mexico’s growing prominence in the field of clinical trials is a testament to its supportive regulatory environment, diverse patient population, and improving healthcare infrastructure. While challenges exist, they can be overcome through collaboration, education, and targeted initiatives.

With ongoing advancements and opportunities in the clinical research landscape, Mexico is poised to play an increasingly significant role in shaping the future of medical research and innovation.

Overview of Clinical Trials in Mexico

Source: Roche

Cohortias the CRO of LATAM

Overview of Clinical Trials in Mexico

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.

Overview of 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.
Overview of 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.

Overview of 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.

Overview of 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

Overview of 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.

Overview of 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
Overview of Clinical Trials in Mexico

The Cohortias Team

Overview of 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

Overview of Clinical Trials in Mexico

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