Clinical Trial Safety in Mexico

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

Locally-Based, Full Service CRO

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Sites Throughout LATAM
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Conducted Studies
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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.

Clinical Trial Safety in Mexico

Clinical Trial Safety in Mexico – Full Service CRO

Clinical trials are a crucial step in the development of new drugs and treatments that can potentially benefit millions of people worldwide. They involve rigorous testing of new therapies and interventions to ensure their safety and efficacy before they are made available to the general public. Clinical trials are typically conducted in a controlled environment under strict guidelines and regulations to minimize risks to participants.

However, in recent years, there have been concerns about the safety of clinical trials, particularly in developing countries like Mexico, where regulations may be lax, and oversight may be inadequate.

Mexico has emerged as a popular destination for clinical trials due to its large population, diverse demographics, and relatively low costs. According to the Mexican Ministry of Health, there were 2,174 clinical trials registered in Mexico in 2020, making it the second most active country in Latin America after Brazil. However, concerns have been raised about the safety of these trials, particularly those involving vulnerable populations like indigenous communities and children.

One of the major issues with clinical trial safety in Mexico is the lack of effective regulatory oversight. The Mexican government has established several agencies to oversee clinical trials, including the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) and the National Bioethics Commission (CONBIOETICA).

However, these agencies have been criticized for their inadequate resources, lack of transparency, and conflicts of interest. In some cases, these agencies have been accused of being too lenient in approving clinical trials without adequate safety measures.

Another issue with clinical trial safety in Mexico is the exploitation of vulnerable populations. Many clinical trials in Mexico involve indigenous communities or people living in poverty who may be willing to participate in trials for financial gain. However, these populations may not fully understand the risks involved in participating in trials or may not have access to adequate healthcare if they experience adverse effects.

There have been several instances where vulnerable populations have been exploited in clinical trials in Mexico, leading to serious health consequences and legal action.

The lack of public awareness and education about clinical trials is another major issue in Mexico. Many people may not fully understand the risks and benefits of participating in clinical trials, which can make them vulnerable to exploitation or lead to unrealistic expectations.

There is also a lack of transparency in the reporting of clinical trial results, which can make it difficult for the public to evaluate the safety and efficacy of new therapies.

Clinical Trial Safety in Mexico

Clinical Trial Safety in Mexico

Clinical Trial Safety in Mexico

Despite these challenges, there are several steps that can be taken to improve the safety of clinical trials in Mexico. The Mexican government can increase funding for regulatory agencies like COFEPRIS and CONBIOETICA to improve their capacity to oversee clinical trials effectively. It can also establish more transparent and accountable mechanisms for monitoring and reporting clinical trial data.

Another important step is to increase public awareness and education about clinical trials. This can be done through public health campaigns, community outreach programs, and partnerships with healthcare providers and patient advocacy groups.

By educating the public about the risks and benefits of clinical trials, people can make informed decisions about participating in trials and help to prevent exploitation and misconduct.

Finally, it is essential to ensure that clinical trials in Mexico adhere to ethical and scientific standards. This means establishing rigorous protocols for the selection of participants, ensuring that they fully understand the risks and benefits of participating in trials, and providing adequate healthcare and follow-up for those who experience adverse effects.

It also means ensuring that clinical trial results are reported transparently and accurately, so that the public can make informed decisions about new therapies.

In conclusion, clinical trial safety in Mexico is a complex and multifaceted issue that requires a comprehensive approach to address. The Mexican government, regulatory agencies, healthcare providers, patient advocacy groups, and the public all have a role to play in ensuring that clinical trials are conducted safely and ethically.

By working together, we can ensure that new therapies are developed in a way that benefits everyone, including those who participate in clinical trials, without compromising their safety and well-being. It is crucial to prioritize the safety and protection of participants in clinical trials, particularly vulnerable populations, and to establish robust mechanisms for oversight and regulation.

Clinical Trial Safety in Mexico

Source: Roche

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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 Safety 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 Safety 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 Safety 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 Safety 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 Safety 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 Safety 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 Safety in Mexico

The Cohortias Team

Clinical Trial Safety 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 Safety in Mexico

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