Clinical Trial Management in Colombia

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

Locally-Based, Full Service CRO

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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 Management in Colombia

Clinical Trial Management in Colombia– Full Service CRO

Clinical trials are vital for advancing medical knowledge and improving patient care. Colombia has emerged as a prominent destination for conducting clinical research, offering a conducive environment for clinical trial management.

In this blog post, we will delve into the regulatory landscape governing clinical trials in Colombia, explore the advantages it presents, and highlight important considerations for local and international stakeholders.

Regulatory Landscape

Clinical trials in Colombia are regulated by the Colombian National Food and Drug Surveillance Institute (INVIMA). INVIMA ensures compliance with ethical and safety standards, aligned with international guidelines such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Researchers planning to conduct clinical trials in Colombia must obtain INVIMA approval, submitting detailed documentation regarding study protocols, participant selection criteria, and investigational products.

Advantages of Conducting Clinical Trials in Colombia

Colombia offers several advantages for clinical trial management. Firstly, it possesses a diverse and sizeable patient population, providing access to a varied demographic pool for participant recruitment.

Additionally, Colombia boasts well-established healthcare infrastructure, experienced investigators, and renowned research institutions, facilitating the smooth execution of clinical trials. The country’s geographic location also enables collaboration with neighboring countries, expanding potential collaborations and enhancing access to resources and expertise.

Furthermore, Colombia has made significant progress in improving its regulatory framework, streamlining the approval process for clinical trials. This efficiency contributes to faster trial initiation and shorter timelines for data collection, analysis, and reporting.

Additionally, the cost of conducting trials in Colombia is often more affordable compared to some developed nations, offering cost-effective research opportunities for sponsors.

Clinical Trial Management in Colombia

Considerations for Clinical Trial Management

While Colombia presents numerous advantages, it is essential to consider certain factors for successful clinical trial management.

Ensuring the protection of participant rights and safety remains paramount, requiring adherence to rigorous ethical standards and international guidelines. Collaboration with local ethics committees and informed consent processes tailored to Colombia’s cultural and linguistic diversity are critical in this regard.

Infrastructure and logistics are important considerations. Establishing robust supply chains for investigational products, implementing effective data management systems, and providing adequate training to local investigators and site staff are key elements of efficient trial management.

Engaging with experienced Contract Research Organizations (CROs) or local research networks can provide valuable support in navigating these challenges and ensuring compliance with regulatory requirements.

Opportunities for Local and International Stakeholders

Clinical trial management in Colombia offers significant opportunities for local and international stakeholders. Local researchers and institutions can contribute to medical advancements, enhance their reputation, and foster collaborations with global organizations.

Additionally, clinical trials attract investment, create job opportunities, and promote the development of research infrastructure, fostering economic growth in the healthcare sector.

International sponsors can leverage Colombia’s regulatory efficiency, diverse patient population, and experienced investigators to conduct trials efficiently. Collaborating with Colombian research centers, hospitals, and CROs allows access to specialized knowledge and local expertise, ensuring successful trial execution. Furthermore, Colombia’s central location in Latin America enables access to a broader patient pool and facilitates multi-country trials across the region.


Clinical trial management in Colombia offers a favorable environment for researchers, institutions, and sponsors seeking to advance medical knowledge and improve patient care. The country’s robust regulatory framework, diverse patient demographics, well-established infrastructure, and experienced investigators make it an attractive destination for clinical research. However, careful consideration of ethical, logistical, and regulatory factors is necessary for successful trial management.

By harnessing the advantages and addressing challenges, Colombia can continue to be a significant contributor to global clinical research, benefiting both its own healthcare sector and patients worldwide.

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.

Clinical Trial Management 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.
Clinical Trial Management 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.

Clinical Trial Management 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.

Clinical Trial Management 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

Clinical Trial Management 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.

Clinical Trial Management 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
Clinical Trial Management in Colombia

The Cohortias Team

Clinical Trial Management 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

Clinical Trial Management in Colombia

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