Posts tagged Colombia
Avantec Vascular Chooses bioaccess™ for a First-In-Human Clinical Study in Latin America
Avantec Vascular Chooses bioaccess™ for a First-In-Human Clinical Study in Latin America

Avantec Vascular Corporation (https://www.avantecvascular.com/), a company in the San Francisco Bay Area dedicated to advancing vascular therapies through innovation, has chosen Latin America as the destination for the first-in-human study of an innovative vascular device. bioaccess™ will help Avantec Vascular with the selection of a principal investigator, the submission of its regulatory dossier for the ministry of health approvals, and other activities related to carrying out the study.

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Clinical TrialsJulio G. Martinez-Clarklatin america, Colombia, MEXICO, first-in-human, clinical study, avantec vascularComment
Welwaze Chooses bioaccess™ to Access the Colombian Medical Device Market with its Celbrea® Product
Welwaze Chooses bioaccess™ to Access the Colombian Medical Device Market with its Celbrea® Product

Welwaze Medical Inc., the manufacturer of the innovative Celbrea® medical device for the detection of early signs of breast disease, has decided to enter the Latin American market and through its master distributor in Latin America, has chosen bioaccess™ as its regulatory and market access consulting firm to aid it in entering the Colombian market.

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Market AccessJulio G. Martinez-Clarklatin america, Market Access Latin America, commercialization, Welwaze, Celbrea, ColombiaComment
N8 Medical Chooses Colombia and bioaccess™ for the Clinical Trial of its CeraShield™ Endotracheal Tubes in Mechanically Ventilated COVID-19 Patients
N8 Medical Chooses Colombia and bioaccess™ for the Clinical Trial of its CeraShield™ Endotracheal Tubes in Mechanically Ventilated COVID-19 Patients

N8 Medical, LLC (N8 Medical) –a clinical-stage medical device company focused on commercializing medical devices that incorporate a novel class of active compounds called ceragenins– has chosen Colombia and bioaccess™ as its contract research organization (CRO) to conduct a clinical trial of its CeraShield™ Endotracheal Tubes in mechanically ventilated COVID-19 patients. bioaccess™ will help N8 Medical with its institutional review board (IRB)/ethics committee approval and regulatory approval at Colombia's regulatory agency (INVIMA).

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Clinical TrialsJulio G. Martinez-Clarkn8 medical, Colombia, cerashield endotracheal tube, covid 19Comment
bioaccess.™ Helps ClarVista Medical (acquired by Alcon) Gain Approval in Colombia to Commercialize its HARMONI® Modular IOL – a Novel IOL Used to Restore Vision after Cataract Surgery
bioaccess.™ Helps ClarVista Medical (acquired by Alcon) Gain Approval in Colombia to Commercialize its HARMONI® Modular IOL – a Novel IOL Used to Restore Vision after Cataract Surgery

ClarVista Medical, Inc. ("ClarVista"), a privately-held ophthalmic device company —acquired by Alcon in 2017— developer of the HARMONI Modular IOL System, a novel intraocular lens (IOL) used to restore vision after cataract surgery, obtained regulatory approval at Colombia's INVIMA to commercialize its HARMONI Modular IOL. bioaccess.™ led the registration process and became ClarVista's legal representative in Colombia. 

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Market AccessJulio G. Martinez-ClarkClarVista Medical, Colombia, medical device registration, invimaComment
CoapTech Considers Colombia For its First-In-Man Clinical Trial to Prove The Efficacy of its Enteral Nutrition Feeding Tube Placement Technology
CoapTech Considers Colombia For its First-In-Man Clinical Trial to Prove The Efficacy of its Enteral Nutrition Feeding Tube Placement Technology

CoapTech is an early-stage medical device company with a patent-pending, platform technology to disrupt the market for enteral nutrition feeding tubes. The CoapTech system will de-skill the procedure for feeding tube placement, offering a simpler, safer, and more affordable method. CoapTech has chosen Colombia to conduct its first-in-man clinical trial. CoapTech has chosen BIOACCESS™ as its CRO to explore conducting this trial in Colombia by helping it find a qualified site and investigator.

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Clinical TrialsJulio G. Martinez-ClarkCoapTech, Percutaneous Ultrasound Gastrostomy (PUG), PUG, fist-in-man, first-in-human, ColombiaComment
Colombia becomes the most clinical trial-friendly country in Latin America; it now boasts the best study protocol approval times in the region: 30 days for medical devices and 60 days for drugs
Colombia becomes the most clinical trial-friendly country in Latin America; it now boasts the best study protocol approval times in the region: 30 days for medical devices and 60 days for drugs

Colombia's National Institute of Food and Drug Monitoring (INVIMA), announced that it has reduced from 4.5 months (135 days) to 2 months (60 days) the processing time for the evaluation and approval of a clinical research human study protocol involving an investigational drug. INVIMA announced this change on its website on April 12, 2016, and also stated that it would achieve this time reduction by improving the efficiency of internal processes without compromising the quality of the evaluation of the study protocol.

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ColombiaJulio G. Martinez-ClarkColombia, clinical trial, invima, approval time, processing timeComment