Guidance in 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.

Guidance in Clinical Trials in Mexico

Guidance in Clinical Trials in Mexico – Full Service CRO

The landscape of clinical trials is a complex and dynamic one, driven by the pursuit of scientific advancements and the development of innovative treatments. In Mexico, as in many countries, clinical trials play a crucial role in bringing new medical interventions to the forefront of healthcare.

However, conducting clinical trials requires a deep understanding of the regulatory framework, ethical considerations, and operational intricacies that guide the process. This article aims to provide a comprehensive overview of the guidance governing clinical trials in Mexico.

Regulatory Framework

Mexico’s regulatory framework for clinical trials is primarily overseen by the Federal Commission for Protection against Sanitary Risks (COFEPRIS), an agency under the Ministry of Health. COFEPRIS ensures that clinical trials adhere to international standards, maintaining a balance between patient safety and scientific progress.

Before initiating a trial, sponsors must submit an Investigational New Drug (IND) application to COFEPRIS, providing comprehensive data on the investigational product’s safety and efficacy. The agency evaluates the application’s scientific validity, ethical considerations, and compliance with Mexican regulations.

Ethical Considerations

Ethical principles are at the core of any clinical trial. In Mexico, research involving human subjects must adhere to the General Health Law, which mandates that trials follow the Declaration of Helsinki and the Good Clinical Practice (GCP) guidelines outlined by the International Council for Harmonisation (ICH).

An Institutional Review Board (IRB) or Ethics Committee (EC) must review and approve the trial protocol, ensuring participant rights, safety, and welfare. Informed consent, transparency, and respect for participant autonomy are central tenets of the ethical framework guiding clinical trials in Mexico.

Operational Aspects

The successful execution of a clinical trial relies on meticulous planning and efficient operations. Once regulatory and ethical approvals are obtained, sponsors can begin enrolling participants. Close collaboration between sponsors, investigators, and research sites is crucial.

Mexico’s diverse population offers a unique advantage for clinical research, but language barriers and cultural considerations must be taken into account. Effective site management, accurate data collection, and monitoring are essential to maintaining the trial’s integrity and quality.

Guidance in Clinical Trials in Mexico

Guidance in Clinical Trials in Mexico

Guidance in Clinical Trials in Mexico

Patient Recruitment and Diversity

Mexico’s rich demographic landscape presents opportunities for diverse patient populations to participate in clinical trials, enhancing the generalizability of study results. However, engaging participants requires culturally sensitive approaches. Tailored recruitment strategies, translated materials, and engagement with local communities are pivotal in building trust and ensuring participation’s voluntary nature.

Challenges and Future Outlook

While Mexico offers a promising environment for clinical trials, certain challenges persist. Funding limitations, administrative hurdles, and regulatory complexities can pose barriers to trial initiation and progression. To address these challenges, collaborations between public and private sectors, international organizations, and academia can foster a more conducive research ecosystem.

Looking ahead, Mexico’s commitment to advancing medical research is evident through ongoing efforts to streamline regulatory processes and enhance infrastructure.

The alignment with international standards, such as ICH-GCP, demonstrates Mexico’s dedication to contributing high-quality data to global scientific endeavors. Continued investment in research capacity, improved training for investigators, and increased public awareness about clinical trials can further bolster Mexico’s position as a hub for clinical research.


Clinical trials are a critical gateway to medical progress, shaping the future of healthcare by introducing new treatments and therapies. In Mexico, navigating the terrain of clinical trials necessitates a deep understanding of the regulatory, ethical, and operational facets that govern the process.

By adhering to international standards, prioritizing ethical considerations, and embracing cultural diversity, Mexico can contribute significantly to the advancement of medical knowledge while upholding patient safety and welfare. As the landscape evolves, collaborative efforts and a commitment to excellence will continue to guide clinical trials toward impactful and transformative outcomes.

Guidance in Clinical Trials in Mexico

Source: Roche

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Guidance in Clinical Trials 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.

Early Phase Trials

- First-in-Human Studies.
- Get to patients faster, no IND necessary.
- Valid data for FDA submission.

Rescue Studies

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- We work alongside Global CROs to get studies back on track.
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Phase II & III Trials

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- Proven infrastructure that can handle any trial.
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- Wide network of sites and physicians.

Medical Devices

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- We take care of everything, from shipping requirements all the way to data collection.
Guidance in Clinical Trials in Mexico

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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.

Guidance in 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.

Guidance in 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

Guidance in 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.

Guidance in 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
Guidance in Clinical Trials in Mexico

The Cohortias Team

Guidance in Clinical Trials 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 Trials in Mexico

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