Client Testimonials — bioaccess®

“bioaccess® has been an invaluable partner in advancing Watershed Therapeutics' clinical programs in Latin America. When we needed to pivot our study plans from Colombia to Panama and El Salvador, the bioaccess® team adapted quickly and seamlessly, helping us navigate regulatory submissions with both MINSA in Panama and the SRS in El Salvador, manage ethics committee filings, and coordinate site feasibility across multiple institutions in both countries. Their deep knowledge of the Latin American regulatory landscape, combined with hands-on project management — from protocol development to logistics coordination — has given us confidence to move forward with our first-in-human device studies in the region.”

“bioaccess® has been an essential partner in supporting Avantec Vascular's clinical development across Latin America. From managing our Golazo® and EndoCoat™ feasibility studies through INVIMA approval in Colombia, to navigating the COFEPRIS regulatory process for EndoCoat™ BTK DES in Mexico, and most recently coordinating our Sangria first-in-human trial in El Salvador, their team has consistently demonstrated deep regulatory expertise across multiple countries. They are responsive, knowledgeable, and truly understand the complexities of conducting first-in-human device trials in emerging markets.”

“Working with bioaccess® on the Himplant® regulatory strategy in Latin America has been an outstanding experience. Their team's deep expertise in navigating complex regulatory environments — from COFEPRIS in Mexico to ANMAT in Argentina — gave us the confidence and clarity we needed to move forward in multiple markets simultaneously. Julio, Katherine, and the entire bioaccess® team are highly responsive, detail-oriented, and genuinely invested in our success. They've become a trusted extension of the IMD team, and I would recommend them without hesitation to any medical device company looking to expand into Latin America.”

“Obtaining approval for a foreign study is always a challenge. bioaccess®'s assistance was invaluable in getting our study approved in Colombia. In addition to having in-depth knowledge of the regulatory approval process, they also have an in-depth understanding of the culture. As a result, bioaccess® can identify and troubleshoot potential problems before they arise. For companies considering a trial in Colombia, I recommend bioaccess® without hesitation.”

“We sincerely appreciate our close partnership with the bioaccess® team. All the team members we interacted with were highly professional and knowledgeable. The team has been exceptional in its support and highly responsive in our engagement thus far. bioaccess® will be our preferred choice for the CRO for any future studies we may consider in Latin America.”

“I have enjoyed working with your team so far. I look forward to getting this trial started.”

“When we needed to move PortIO from the bench to first-in-human as quickly and rigorously as possible, bioaccess® delivered. They secured regulatory approval in Colombia in just five weeks, assembled an outstanding interventional radiology team, and managed every aspect of the study — from site preparation to patient enrollment to structured data collection. The study was completed ahead of schedule, within budget, and the results have now been published in the Journal of Vascular Access. For any MedTech company looking to generate high-quality first-in-human clinical data, bioaccess® is the partner you want.”

“What helped us a lot in working with bioaccess® was building the relationship with them as a CRO first — it helped us work with them less as a consulting CRO and more as an extension of our clinical team. The bioaccess® team understood what we were trying to achieve and understood our device, and that helped them translate, both literally and figuratively, to the clinical teams at our study sites and speak in our voice. They weren't just a conduit — they had knowledge of the device, the procedure, and why this technology was ready for first-in-human. That made all the difference.”