Ethical considerations in Clinical Trials in Colombia

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

Locally-Based, Full Service CRO

Contact us today to learn more.

+ 0
Sites Throughout LATAM
+ 200
Patients in our network
+ 0
Conducted Studies
0 %
Lost-to-Follow Up rate
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.

Ethical considerations in Clinical Trials in Colombia

Ethical considerations in Clinical Trials in Colombia – Cohortias the CRO of LATAM

Clinical trials are essential for advancing medical knowledge and improving patient care. In Colombia, strict ethical considerations are in place to safeguard the rights, well-being, and dignity of clinical trial participants.

This blog explores the ethical dimensions of clinical trials in Colombia, highlighting key principles and regulations that ensure ethical research practices.

Informed Consent and Participant Autonomy


In Colombia, obtaining informed consent from participants is a fundamental ethical requirement in clinical trials. Researchers must provide clear and comprehensive information about the study purpose, procedures, potential risks and benefits, and the right to withdraw consent at any time.


Informed consent ensures that participants are fully informed and make voluntary decisions regarding their participation, respecting their autonomy and personal values.


Institutional Review Boards


Colombia mandates the establishment of Institutional Review Boards (IRBs) or Ethics Committees to review and approve clinical trial protocols. These independent committees consist of multidisciplinary experts, including medical professionals, scientists, ethicists, and community representatives. IRBs evaluate the ethical and scientific aspects of the trial, ensuring participant protection, research integrity, and adherence to national and international guidelines.


Protection of Vulnerable Populations


Colombia places significant emphasis on the protection of vulnerable populations in clinical trials. This includes minors, pregnant women, prisoners, individuals with cognitive impairments, and marginalized communities. Additional safeguards, such as obtaining informed consent from legally authorized representatives and independent assessment of decision-making capacity, are implemented to ensure their well-being and autonomy.

Ethical considerations in Clinical Trials in Colombia

Ethical considerations in Clinical Trials in Colombia

Ethical considerations in Clinical Trials in Colombia

Risk-Benefit Assessment


Ethical considerations require a careful evaluation of the potential risks and benefits for participants in clinical trials. In Colombia, trials must undergo a comprehensive risk-benefit assessment to ensure that potential benefits outweigh the risks. This assessment serves to protect participant welfare, minimize unnecessary harm, and ensure that trials are conducted ethically and responsibly.


Data Confidentiality and Privacy


Respecting participant confidentiality and privacy is paramount in ethical clinical research.


Colombian regulations mandate that personal information collected during clinical trials must remain confidential and secure. Researchers and sponsors must implement strict data protection measures to safeguard participant identities and ensure anonymization of collected data.This ensures participant privacy, fosters trust, and upholds ethical standards.


Colombia’s commitment to ethical considerations in clinical trials reflects its dedication to participant welfare and research integrity. The robust regulatory framework, encompassing informed consent, IRB oversight, protection of vulnerable populations, risk-benefit assessments, and data confidentiality, ensures that trials are conducted ethically and responsibly.

These ethical considerations not only safeguard participant rights and well-being but also enhance the credibility and reliability of clinical trial data. By upholding ethical standards, Colombia contributes to the advancement of medical knowledge, improved patient care, and the overall integrity of clinical research.

Ethical considerations in Clinical Trials in Colombia

Source: Pro Colombia

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.

Ethical considerations in Clinical Trials in Colombia

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.
Ethical considerations in Clinical Trials in Colombia

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.

Ethical considerations in Clinical Trials in Colombia

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.

Ethical considerations in Clinical Trials in Colombia

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

Ethical considerations in Clinical Trials in Colombia

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.

Ethical considerations in Clinical Trials in Colombia

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
Ethical considerations in Clinical Trials in Colombia

The Cohortias Team

Ethical considerations in Clinical Trials in Colombia

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

Ethical considerations in Clinical Trials in Colombia

Network & Partnerships