ARHI and bioaccess™ Sign Memorandum of Understanding for Clinical Research Collaboration in Latin America
Naples, FL., July 22, 2019 — Advanced Research for Health Improvement LLC (ARHI) —a leading clinical research site in Naples, FL that has specialized in conducting clinical trials in the area of heart failure, heart disease, Alzheimer’s disease, aging frailty, among others— has executed an memorandum of understanding (MOU) with bioaccess™ —the only contract research organization (CRO) that helps US medical device company operationalize early-stage/first-in-human clinical trials in Colombia—. The purpose of the MOU is to explore collaboration opportunities on clinical research projects in Latin America with a special emphasis in Colombia —the country with the most competitive medical device clinical trial environment in Latin America.
ARHI's core team has a combined 50+ years of experience in conducting clinical trials and wishes to extend its reach and partner with CROs and similar clinical research sites in Latin America. In order to reach its goals, ARHI has become interested in the work that bioaccess™ has done in Colombia, South America since 2010. bioaccess™ is an Orlando, FL boutique CRO that has helped a significant number of US medical device companies operationalize early-stage/first-in-human clinical trials at clinical research sites in Colombia, and, as such, has expressed a willingness to explore future collaborative efforts with ARHI.
Colombia boasts a fast 30-day study application review time at its Ministry of Health; fast subject recruitment due to its 50-million population with full access to a universal health care system; and cost savings of 30-50% off of hospital fees in the US. This, on top of a privileged geographical location in the same EST time zone with direct short flights and a free-trade agreement with the US to ensure fast importation of investigational products. Colombia also has a superb quality health care infrastructure —over 40% of the best clinics and hospitals in Latin America are located in Colombia.
For about 10 years, bioaccess™ has helped a significant number of US medical device companies conduct their first-in-human trials in Colombia including DirectFlow, CeloNova, InterValve, Mitralign, Mitraspan, Avinger, Hancock Jaffe Laboratories, Flow-FX, ReGelTec, and others. bioaccess™ services include regulatory study submission to the ethics committees and the Ministry of Health, importation of the investigational devices, study management, and all other activities necessary to ensure its clinical trial sponsors expeditiously gather the clinical data they need from research sites in Colombia.
The MOU between ARHI and bioaccess™ include discussions to explore the parameters and feasibility of the following collaborative efforts: a) methods by which ARHI and bioaccess™ can assist each other consult, and/or collaborate on clinical and research initiatives; b) methods by which ARHI and bioaccess™ can facilitate and encourage the exchange of their respective team members; c) method(s) by which ARHI and bioaccess™ could co-operationalize clinical research project for US sponsors in Colombia.
“This collaboration between bioaccess™ and AHRI promises to be very exciting. The combined local know-how of bioaccess™ and the experience of ARHI in medical research makes this seem like the perfect match to contribute to the development of the biotechnology and clinical research sectors in Colombia. The government and medical experts in Colombia are investing large amounts of time and effort in promoting biotechnology and clinical research in their country, and we want to be part of that growth," said Dr. Julian Javier, ARHI co-founder.
About Advanced Research for Health Improvement (ARHI)
ARHI is a leading clinical research site in Naples, FL that has specialized in conducting clinical trials in the area of heart failure, heart disease, Alzheimer’s disease, aging frailty, among others. ARHI's core team has a combined 50+ years of experience in conducting clinical trials. ARHI was co-founded by Dr. Julian Javier —a board-certified Interventional cardio-vascular specialist who has authored six books chapters and multiple peer-reviewed articles in endovascular disease and has been the principal investigator in many trials developing new therapeutic techniques to treat the endovascular disorder. Dr. Javier is also a frequently invited speaker in many National and International conferences for venous disorders. More information at www.arhiusa.com.
bioaccess™ is a Florida-based clinical research organization (CRO) and market access consulting company that helps innovative Medtech companies conduct early-stage clinical research and commercialize their innovations in Colombia and the rest of Latin America. More information at www.bioaccessla.com.
bioaccess™ Press Contact:
Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210