Clinical Trial Management in Mexico

Clinical Trials in: Mexico, Argentina, Colombia and Brazil.

Locally-Based, Full Service CRO

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Clinical Trial Management in Mexico
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.

Clinical Trial Management in Mexico

Clinical Trial Management in Mexico – Full Service CRO

Clinical trials play a crucial role in advancing medical research and developing innovative treatments. As a global hub for pharmaceutical research, Mexico offers a conducive environment for conducting clinical trials.

In this blog post, we will delve into the intricacies of clinical trial management in Mexico, exploring the regulatory landscape, potential benefits, challenges, and opportunities for both local and international stakeholders.

Regulatory Landscape

The regulatory framework for clinical trials in Mexico is overseen by the Federal Commission for Protection against Sanitary Risks (COFEPRIS).

COFEPRIS ensures that clinical trials adhere to ethical and safety standards, aligning with international guidelines such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Prior to initiating a clinical trial, researchers must obtain approval from COFEPRIS, providing detailed documentation on study protocols, participant selection criteria, and investigational products.

Benefits of Conducting Clinical Trials in Mexico

 Mexico offers several advantages for conducting clinical trials. Firstly, the country boasts a diverse and sizable patient population, enhancing the potential for participant recruitment. Additionally, Mexico’s geographical proximity to the United States facilitates collaborations with American institutions and fosters access to a wider pool of resources and expertise.

Moreover, Mexico’s lower cost of conducting trials compared to some developed countries makes it an attractive destination for sponsors seeking cost-effective research opportunities. Furthermore, Mexico’s rich cultural and genetic diversity provides a unique opportunity to study varied patient demographics, leading to more comprehensive and generalizable results.

Clinical Trial Management in Mexico

Clinical Trial Management in Mexico

Challenges and Mitigation Strategies

While Mexico presents numerous opportunities for clinical trials, certain challenges must be addressed. One primary concern is ensuring the protection of participant rights and safety. Maintaining rigorous ethical standards and adherence to international guidelines is crucial in this regard.

Language barriers may also arise, especially when conducting trials in indigenous communities or rural areas. Engaging local interpreters and translators can mitigate these challenges and ensure effective communication between researchers and participants.

Another challenge relates to infrastructure and logistics. It is essential to establish robust supply chains for investigational products, implement effective data management systems, and provide adequate training to local investigators and site staff. Collaborating with experienced Contract Research Organizations (CROs) can help navigate these challenges and ensure efficient trial management.

Opportunities for Local and International Stakeholders

Clinical trial management in Mexico presents various opportunities for both local and international stakeholders. For local researchers and institutions, conducting trials offers the chance to contribute to medical advancements, enhance academic recognition, and forge collaborations with multinational organizations. Additionally, clinical trials can spur economic growth by attracting investment, creating job opportunities, and fostering technological advancements in the healthcare sector.

International sponsors can leverage Mexico’s favorable regulatory environment and vast patient pool to expedite trial recruitment and gather diverse data. Collaborating with Mexican research centers and CROs enables access to specialized knowledge and local expertise, ensuring successful trial execution.

Moreover, multinational pharmaceutical companies can benefit from Mexico’s strategic location and well-established infrastructure, facilitating seamless trial coordination across North America.


Clinical trial management in Mexico presents an array of opportunities for researchers, institutions, and sponsors seeking to advance medical knowledge and improve patient care. With a robust regulatory framework, diverse patient demographics, cost-effective operations, and strategic geographic positioning, Mexico offers a favorable environment for conducting clinical trials.

Addressing challenges related to ethics, infrastructure, and logistics is crucial to ensure the successful execution of trials. By embracing these opportunities and working collaboratively, Mexico can continue to play a pivotal role in global clinical research, ultimately benefiting patients worldwide.

Clinical Trial Management in Mexico

Source: Roche

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.

Clinical Trial Management 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.
Clinical Trial Management 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.

Clinical Trial Management 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.

Clinical Trial Management 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

Clinical Trial Management 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.

Clinical Trial Management 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
Clinical Trial Management in Mexico

The Cohortias Team

Clinical Trial Management 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

Clinical Trial Management in Mexico

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