Drug Safety in Clinical Trials in Colombia

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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.

Drug Safety in Clinical Trials in Colombia

Drug Safety in Clinical Trials in Colombia – Cohortias the CRO of LATAM

Clinical trials serve as a crucial gateway to advancing medical knowledge and introducing innovative treatments to patients. Safeguarding participant well-being and ensuring drug safety are paramount during these trials. In Colombia, a well-regulated clinical trial environment exists to protect participants and maintain the highest ethical standards.

This blog post will provide an in-depth exploration of drug safety in clinical trials in Colombia, including the regulatory framework, ethical considerations, monitoring mechanisms, and collaborative efforts among stakeholders.

Regulatory Framework and Oversight

Colombia has established a robust regulatory framework for the oversight of clinical trials to ensure drug safety. The regulatory authority responsible for this oversight is the National Food and Drug Surveillance Institute (INVIMA). INVIMA ensures that clinical trials comply with ethical principles, follow international guidelines, and evaluate the risks and benefits associated with investigational drugs.

Clinical trials conducted in Colombia undergo a rigorous review process, including approval from an ethics committee and authorization from INVIMA. The ethics committee evaluates key aspects such as study design, participant selection criteria, informed consent procedures, and safety monitoring plans. By adhering to stringent regulations and oversight mechanisms, Colombia maintains a high standard of drug safety in clinical trials.

Ethical Considerations and Informed Consent

Ethical considerations are at the core of clinical trials in Colombia. The principles of autonomy, beneficence, and justice guide the ethical decision-making process. Ensuring informed consent is a crucial aspect of protecting participants’ rights and promoting drug safety.

Informed consent in Colombia requires providing comprehensive information to participants in a language they understand. This includes details about the investigational drug, study procedures, potential risks, benefits, and alternatives. Participants should have sufficient time to ask questions and make an informed decision about their participation in the trial.

Drug Safety in Clinical Trials in Colombia

Drug Safety in Clinical Trials in Colombia

Drug Safety in Clinical Trials in Colombia

Monitoring and Pharmacovigilance

Monitoring and pharmacovigilance mechanisms play a vital role in maintaining drug safety throughout clinical trials in Colombia. INVIMA requires investigators to implement robust safety monitoring plans to promptly detect and manage adverse events or unexpected reactions.

Monitoring activities include regular inspections of clinical trial sites by regulatory authorities, ensuring compliance with protocols, good clinical practices (GCP), and ethical guidelines. These inspections help identify any deviations from approved protocols, ensuring the safety and integrity of the trials.

Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, is also crucial in drug safety during clinical trials. Investigators and sponsors have an obligation to report all adverse events to INVIMA within specified timelines. INVIMA collaborates with international agencies and experts to evaluate the reported data and take necessary actions to protect participant safety.

Collaboration and Future Perspectives

Ensuring drug safety in clinical trials requires collaboration among stakeholders, including researchers, ethics committees, regulatory authorities, and sponsors. In Colombia, efforts to strengthen these collaborations, promote transparency, and protect participant rights are ongoing.

Looking ahead, Colombia aims to further enhance drug safety in clinical trials by harnessing emerging technologies and fostering international collaborations. The adoption of electronic data capture, real-time monitoring systems, and advanced analytics can streamline safety reporting and signal detection, leading to more efficient risk management.


Colombia maintains a stringent regulatory framework and ethical guidelines to prioritize drug safety in clinical trials. With the active participation of regulatory authorities, ethics committees, and stakeholders, Colombia ensures that trials are conducted with utmost care, protecting the well-being of participants. By continuing to embrace advancements in technology and fostering international collaborations, Colombia is well-positioned to further enhance drug safety in clinical trials and contribute to the advancement of medical research.

Drug Safety in Clinical Trials in Colombia

Source: Pro Colombia

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Drug Safety in Clinical Trials in Colombia

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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.

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Drug Safety in Clinical Trials in Colombia

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Latin America offers access to emerging markets, providing an opportunity for pharmaceutical companies to expand their reach and reach new patient populations.

Drug Safety 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.

Drug Safety 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

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Beta Trials Platform

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Medical Devices

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Phases I – III

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  • Diabetes/Metabolic Syndromes
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Drug Safety 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

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  • 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.

Drug Safety 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
Drug Safety in Clinical Trials in Colombia

The Cohortias Team

Drug Safety in Clinical Trials in Colombia

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Drug Safety in Clinical Trials in Colombia

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