Posts tagged first-in-man
LATAM's Regulatory Framework For Medtech Early Feasibility Studies
LATAM's Regulatory Framework For Medtech Early Feasibility Studies

U.S. medtech companies are increasingly searching for a destination where they can recruit patients faster, easier, and cheaper for their early feasibility studies. Medtech companies want to avoid the uncertainty of the FDA Investigational Device Exemption (IDE) review process. Due to the new European Medical Device Directive (MDR) 's difficulties since May 2021, the medtech clinical trial pendulum is shifting from Eastern Europe to Latin America. Many more medtech companies are now looking at Latin America as their destination for their early feasibility research instead of Eastern Europe.

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Clinical Research, Clinical Trial, Investigación clínica, ColombiaJulio G. Martinez-Clarkearly stage clinical trial, early feasibility clinical trial, first-in-human, first-in-man, medical device clinical trial, regulatory frComment
Latin America's Landscape For Medtech Clinical Trials
Latin America's Landscape For Medtech Clinical Trials

This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America, particularly in Colombia and Paraguay. I will address critical success factors and provide recommendations to ensure cost-effective, ethical, and quality EFS and FIH medtech clinical trials in the region.

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Clinical Research, Clinical Trial, Investigación clínicaJulio G. Martinez-Clarkclinical trials, clinical research, Clinical trials in Colombia, investigación clínica, colombia regulatory, medical devices, medtech, first-in-man, first-in-human, early stage clinical trial, early feasibility clinical trialComment
4 Time Variables that a Medical Device Company Must Evaluate to Start a First-In-Human Medical Device Clinical Trial in Colombia
4 Time Variables that a Medical Device Company Must Evaluate to Start a First-In-Human Medical Device Clinical Trial in Colombia

The time it takes to approve a clinical research study in Colombia has four main variables. The first is the search for the principal investigator (PI) and his/her associated hospital where he/she practices and has the right patient population (aka IPS in Colombia). The second is the approval time of the ethics committee associated with the IPS. The third is the approval time in the regulatory agency (INVIMA), and the fourth is the approval time of the import permit of the devices under investigation (VUCE). In this blog post, we will explain the reason why the selection of the principal investigator is really what could make a study successful or not.

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Colombia, Clinical Trial, Clinical Research, INVIMAJulio G. Martinez-Clarkfirst-in-man, first-in-human, medical devices, colombia, early stage clinical trial, early feasibility clinical trialComment
Three Steps for a Medical Device Startup to Run a First-In-Human Clinical Trial in Colombia and Gather Quality Data at a Fraction of the Cost
Three Steps for a Medical Device Startup to Run a First-In-Human Clinical Trial in Colombia and Gather Quality Data at a Fraction of the Cost

Colombia's Ministry of Health (MoH) has one of the fastest regulatory approval times in Latin America: 30 days. The country also boasts a top-performing universal healthcare system that covers about 95% of its 50-million population and competitive hospital fees that are about 30-50% less than in the US or other Western European countries. The EC and INVIMA will evaluate the study protocol, the investigator's brochure, the patient informed consent form (ICF), the case report form (CRF), all information about the investigational product (e.g., biocompatibility tests, reports of unexpected adverse events), the study insurance policy, and all advertising material planned to recruit patients. You must also apply for an import permit at VUCE (Ventanilla Única de Comercio Exterior) —an office within Colombia's Ministry of Commerce, Industry, and Tourism (MinCIT).

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Clinical Research, Clinical TrialJulio G. Martinez-Clarkfirst-in-human, medtech, Clinical trials in Colombia, colombia, invima, first-in-manComment