Biomarkers in Clinical Trials

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

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biomarkers in clinical trials
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.

Biomarkers in clinical trials

The Role of Biomarkers in Clinical Trials – Clinical Research in Latin America

Clinical trials are an essential part of medical research that aim to evaluate the safety and efficacy of new drugs, medical devices, or treatments in human subjects.

These trials are usually conducted in several stages, starting with small, early-phase studies that test the safety and tolerability of a new intervention in a small group of people.

As the trial progresses, larger and more complex studies are conducted to assess the effectiveness of the intervention in larger populations.

One of the key challenges in clinical trials is to accurately measure the efficacy of the intervention being tested.

In some cases, this can be straightforward, such as when a new drug has a clear therapeutic effect that can be measured using standard clinical endpoints such as disease progression, survival, or quality of life.

However, in many cases, the endpoint of interest may be more subtle or difficult to measure, making it challenging to determine whether the intervention is effective.

This is where biomarkers can play a critical role in clinical trials.

Biomarkers are defined as measurable indicators of biological processes, such as gene expression, protein levels, or metabolite concentrations, that can be used to diagnose diseases, track disease progression, or predict response to treatment.

Biomarkers can be used in clinical trials to help researchers identify and quantify the effects of an intervention, even when the clinical endpoints are difficult to measure or take a long time to develop.

Biomarkers in clinical trials

There are several ways to use biomarkers in clinical trials:

-As surrogate endpoints:

Surrogate endpoints are intermediate endpoints that are used to predict clinical outcomes, such as disease progression or survival. Biomarkers can serve as surrogate endpoints in clinical trials by providing early indicators of the effectiveness of an intervention. 

For example, a biomarker that is closely associated with disease progression could be used to monitor the effectiveness of a new drug in a clinical trial, even if the clinical endpoint of interest (e.g., survival) takes years to develop.

-To stratify patients:

Biomarkers can be used to stratify patients in clinical trials based on their likelihood of responding to a particular treatment. 

This can help researchers identify the subgroups of patients who are most likely to benefit from the intervention being tested. 

For example, a biomarker that is predictive of drug response could be used to identify patients who are most likely to benefit from a new cancer therapy.

-To monitor safety:

Biomarkers can also be used to monitor the safety of an intervention in clinical trials. 

For example, changes in liver enzymes or kidney function may indicate toxicity of a drug. 

Monitoring these biomarkers can help identify potential safety issues early in the development process and allow researchers to make adjustments to the intervention as necessary.

-To assess mechanism of action:

Biomarkers can also be used to assess the mechanism of action of a new intervention. 

For example, if a new drug is designed to target a specific pathway or receptor, biomarkers that reflect the activity of that pathway or receptor can be used to confirm that the drug is having its intended effect.

Overall, the use of biomarkers in clinical trials can help accelerate the development of new treatments and improve patient outcomes.

By providing early indicators of the effectiveness of an intervention, biomarkers can help researchers make informed decisions about whether to continue development of a new intervention, adjust the dosing or duration of treatment, or identify the patients who are most likely to benefit from the intervention.

However, it is important to note that biomarkers are not a panacea for all of the challenges associated with clinical trial design and interpretation. 

Biomarkers must be carefully validated and their relationship to clinical outcomes must be thoroughly understood before they can be used to guide clinical decision-making.

Additionally, biomarkers should be used in conjunction with other measures of efficacy, such as clinical endpoints and patient-reported outcomes, to provide a comprehensive understanding of the benefits and risks of a new intervention.

Challenges in Biomarker Development

Despite the many benefits of biomarkers in clinical trials, there are also several challenges associated with their development and use.

One of the biggest challenges is the identification of biomarkers that are relevant to the disease being studied.

Biomarker discovery can be a time-consuming and costly process, and not all biomarkers will be suitable for use in clinical trials.

Another challenge is the validation of biomarkers.

Before a biomarker can be used in a clinical trial, it must be validated to ensure that it is reliable and reproducible.

This can be a difficult and time-consuming process, as biomarkers can be affected by a wide range of factors, including sample collection, storage, and analysis.

Finally, there is the challenge of regulatory approval. In order for a biomarker to be used as part of a clinical trial, it must be approved by regulatory agencies such as the FDA.

This can be a complex and time-consuming process, as regulators must evaluate the scientific evidence supporting the use of the biomarker and determine whether it is safe and effective.

Biomarkers in clinical trials

Biomarkers in Clinical Trials

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.

Biomarkers in Clinical Trials

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.
Biomarkers in Clinical Trials

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.

Biomarkers in Clinical Trials

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.

Biomarkers in Clinical Trials

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
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  • Respiratory
  • Oncology

Biomarkers in Clinical Trials

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.

Biomarkers in Clinical Trials

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
Biomarkers in Clinical Trials

The Cohortias Team

Biomarkers in Clinical Trials

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

Biomarkers in Clinical Trials

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