Guidance in Clinical Trials in Argentina

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 Argentina

Guidance in Clinical Trials in Argentina – Full Service CRO

Clinical trials stand as the cornerstone of medical advancement, propelling the development of new treatments and reshaping the future of healthcare. In Argentina, much like in other countries, clinical trials play a vital role in bridging the gap between scientific discovery and patient care.

Navigating the intricate regulatory landscape, understanding ethical considerations, and effectively managing operational aspects are essential for conducting successful trials. This article aims to provide an extensive exploration of the guidance that shapes clinical trials in Argentina.

Regulatory Framework

The regulatory oversight of clinical trials in Argentina is managed by the National Administration of Drugs, Foods, and Medical Devices (ANMAT). ANMAT is responsible for evaluating and approving clinical trial applications, ensuring that research adheres to international standards while safeguarding patient well-being.

Prior to commencement, sponsors must submit a Clinical Trial Authorization (CTA) application to ANMAT, including comprehensive information on the investigational product’s safety, efficacy, and trial protocol. ANMAT evaluates the scientific validity, ethical considerations, and compliance with Argentine regulations.

Ethical Considerations

Ethical principles form the cornerstone of clinical trials, emphasizing the paramount importance of participant safety and informed consent. In Argentina, research involving human subjects is guided by the principles of the Declaration of Helsinki and the Good Clinical Practice (GCP) guidelines.

Ethical approval from an accredited Ethics Committee (EC) is a prerequisite for initiating a clinical trial. The EC ensures that the trial protocol upholds participants’ rights, safety, and welfare. Obtaining informed consent is pivotal, necessitating clear and transparent communication with potential participants.

Operational Aspects

The successful execution of a clinical trial in Argentina hinges on meticulous planning and efficient operations. After obtaining regulatory and ethical approvals, sponsors can initiate participant recruitment. Collaborative efforts among sponsors, investigators, and research sites are pivotal.

Argentina’s diverse population provides a unique advantage for clinical research, but cultural sensitivities and regional differences must be taken into consideration. Rigorous site management, precise data collection, and vigilant monitoring are crucial to maintaining the trial’s integrity and quality.

Guidance in Clinical Trials in Argentina

Guidance in Clinical Trials in Argentina

Guidance in Clinical Trials in Argentina

Patient Recruitment and Diversity

Argentina’s demographic diversity offers an invaluable opportunity to engage a wide array of patient populations in clinical trials. This diversity enhances the generalizability of study results and contributes to a more comprehensive understanding of treatment outcomes.

However, tailored strategies that respect language preferences, cultural nuances, and local sensitivities are essential for effective patient recruitment. Building trust through transparent communication and education about the benefits of clinical research can foster greater participation.

Challenges and Future Outlook

While Argentina holds promise as a clinical trial hub, certain challenges persist. Financial limitations, administrative complexities, and regulatory intricacies can hinder the initiation and progress of trials.

Overcoming these challenges requires collaboration between the public and private sectors, academia, and international organizations. Streamlining regulatory processes, bolstering research infrastructure, and providing investigator training can create an environment conducive to high-quality clinical research.

Looking ahead, Argentina’s commitment to advancing medical science is evident through ongoing efforts to enhance regulatory frameworks and research capabilities. By aligning with international standards and fostering a culture of research excellence, Argentina can continue to contribute valuable data to the global scientific community.

Continued investment in research capacity, infrastructure development, and public awareness initiatives will solidify the country’s position as a key player in clinical research.


Clinical trials serve as a vital conduit for medical progress, reshaping healthcare through the introduction of innovative treatments. In Argentina, successfully navigating the landscape of clinical trials requires a comprehensive understanding of the regulatory, ethical, and operational aspects that guide the process.

By upholding international standards, prioritizing ethical considerations, and embracing diversity, Argentina can significantly contribute to advancing medical knowledge while safeguarding participant well-being. As the clinical research landscape evolves, collaborative efforts and a dedication to excellence will continue to guide clinical trials toward transformative breakthroughs that benefit patients around the world.

Guidance in Clinical Trials in Argentina

Source: World Courier

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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.

Guidance in Clinical Trials in Argentina

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.
Guidance in Clinical Trials in Argentina

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.

Guidance in Clinical Trials in Argentina

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 Argentina

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 Argentina

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 Argentina

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 Argentina

The Cohortias Team

Guidance in Clinical Trials in Argentina

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

Guidance in Clinical Trials in Argentina

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