Regulatory Affairs in Clinical Trials in

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.

Regulatory Affairs in Clinical Trials in Argentina

Regulatory Affairs in Clinical Trials in Argentina – Clinical Rsearch LATAM

Clinical trials play a vital role in advancing medical research and bringing new treatments to patients. However, the successful conduct of clinical trials necessitates adherence to robust regulatory frameworks to ensure patient safety and data integrity.

In Argentina, a prominent player in the Latin American healthcare landscape, regulatory affairs in clinical trials are governed by stringent guidelines and processes. This blog post delves into the intricacies of regulatory affairs in clinical trials in Argentina, shedding light on key considerations and challenges faced by sponsors, investigators, and regulatory authorities.

Regulatory Landscape in Argentina

Argentina’s regulatory framework for clinical trials is overseen by the National Administration of Drugs, Food and Medical Technology (ANMAT) and the National Committee of Ethics in Research (CONEP).

ANMAT serves as the main regulatory authority responsible for evaluating and approving clinical trial applications, while CONEP focuses on ethical considerations. These regulatory bodies work in tandem to ensure the safety, efficacy, and ethical conduct of clinical trials in Argentina.

The Approval Process

To initiate a clinical trial in Argentina, sponsors must seek approval from both ANMAT and CONEP. The process commences with the submission of a comprehensive dossier containing detailed information on the investigational product, study protocol, and supporting documentation.

ANMAT reviews the dossier to assess the safety, quality, and efficacy of the proposed trial. The evaluation may involve a rigorous analysis by multidisciplinary experts. Once ANMAT grants approval, sponsors proceed to obtain ethical clearance from CONEP, which evaluates the trial design and ethical considerations.

Regulatory Affairs in Clinical Trials in Argentina

Regulatory Affairs in Clinical Trials in Argentina

Clinical trials play a vital role in advancing medical research and bringing new treatments to patients. However, the successful conduct of clinical trials necessitates adherence to robust regulatory frameworks to ensure patient safety and data integrity.

In Argentina, a prominent player in the Latin American healthcare landscape, regulatory affairs in clinical trials are governed by stringent guidelines and processes. This blog post delves into the intricacies of regulatory affairs in clinical trials in Argentina, shedding light on key considerations and challenges faced by sponsors, investigators, and regulatory authorities.

Regulatory Landscape in Argentina

Argentina’s regulatory framework for clinical trials is overseen by the National Administration of Drugs, Food and Medical Technology (ANMAT) and the National Committee of Ethics in Research (CONEP).

ANMAT serves as the main regulatory authority responsible for evaluating and approving clinical trial applications, while CONEP focuses on ethical considerations. These regulatory bodies work in tandem to ensure the safety, efficacy, and ethical conduct of clinical trials in Argentina.

The Approval Process

To initiate a clinical trial in Argentina, sponsors must seek approval from both ANMAT and CONEP. The process commences with the submission of a comprehensive dossier containing detailed information on the investigational product, study protocol, and supporting documentation.

ANMAT reviews the dossier to assess the safety, quality, and efficacy of the proposed trial. The evaluation may involve a rigorous analysis by multidisciplinary experts. Once ANMAT grants approval, sponsors proceed to obtain ethical clearance from CONEP, which evaluates the trial design and ethical considerations.

Regulatory Affairs in Clinical Trials in Argentina

Source: World Courier

Regulatory Affairs in Clinical Trials in Argentina

Cohortias the CRO of LATAM

Welcome to Cohortias!

The CRO
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.

Regulatory Affairs in Clinical Trials in

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.

Regulatory Affairs in Clinical Trials in

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.

Regulatory Affairs in Clinical Trials in

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.

Regulatory Affairs in Clinical Trials in

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.

CLINICAL DEVELOPMENT

Site Management

Data Management

Site Selection

Regulatory Submissions

Clinical Monitoring

Protocol Development

CLINICAL TRIAL SERVICES

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

MAIN THERAPEUTIC AREAS

Diabetes/Metabolic Syndromes
Infectious Diseases
Cardiovascular
Neurology
Respiratory
Oncology

Regulatory Affairs in Clinical Trials in

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.

Regulatory Affairs in Clinical Trials in

We provide our services with offices in:

Argentina,
Brazil,
Colombia &
Mexico.

Regulatory Affairs in Clinical Trials in

The Cohortias Team

Regulatory Affairs in Clinical Trials in

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

Regulatory Affairs in Clinical Trials in

Network & Partnerships

CROs alliance of Mexico

Health System of Tec de Monterrey

The Science CRO of Europe