Getting to Know bioaccess™: LATAM CRO Experts

What solution does bioaccess™ offer?

Do you know that Medtech startups struggle to recruit subjects quickly, ethically, and cost-effectively to validate the safety and efficacy of their innovations? Well, that’s the problem we solve. By matching their planned clinical research studies with motivated investigators in Latin America, we help these companies get fast, ethical, quality, and cost-efficient clinical data.

What happens if a company chooses not to engage bioaccess™?

Suppose companies with the problem we solve choose not to engage us. In that case, they will experience a delay in validating the safety and efficacy of their innovations, which means unhappy investors and a delay in selling their companies to a strategic acquirer.

What keeps Medtech startup founders and CEOs awake at night?

What keeps Medtech startup founders and CEOs awake at night is the fear that their innovations can't be validated in humans soon enough to be unable to meet investor milestones and unable to have an "exit."

What do Medtech founders and CEOs dream about?

What Medtech founders and CEOs dream about is quickly validating the safety and efficacy of their innovations to keep their investors happy and have an "exit" by selling their companies to a strategic acquirer. We help ensure this happens by matching their clinical studies with investigators in Latin America so that they can get fast, ethical, quality, and cost-efficient clinical data to prove to their investors, the FDA, and their potential strategic acquirers the safety and efficacy of their innovations.

What is most impressive about bioaccess™ and its offering that clients most appreciate, value, and respect?

  • Fast responsiveness

  • Professionalism

  • Expert knowledge and experience in the Medtech space

  • Extensive network of clinical research sites in Latin America

What are your most tangible results/accomplishments for your past or existing customers?

  • Fast search and selection of candidate investigators for their clinical trials

  • Fast ethics committee and regulatory approvals of their clinical trials

  • Fast recruitment of the subjects they need for their clinical trials

How is bioaccess™ better than the competitors?

  • bioaccess™ is the only Medtech-focused CRO in Latin America

  • bioaccess™ is the only CRO in Latin America that helps US Medtech startups with their clinical trials in the region

  • bioaccess™ is the only Medtech CRO in Latin America that has regional coverage and can execute a medical device human study in any country of the region

What's a short description of bioaccess™?

bioaccess™ is the only Medtech CRO in Latin America that collaborates with US Medtech startups seeking accelerated clinical study results in the region.

What area(s) of expertise does bioaccess™ cover most competently?

bioaccess™ has a deep understanding of:

  • Medtech innovation

  • Medtech early-feasibility clinical trials

  • Medtech startups need fast, ethical, and cost-efficient clinical research.

What state or activities are bioaccess™ potential clients in or doing that would indicate it can help them? What needs to be true for them to have the problem bioaccess™ solves?

  • We know that we can help a company/decision maker when they desire to validate the safety and efficacy of their medical devices in humans.

  • We know we can help a company/decision maker when they are doing or want to be doing early-feasibility medical device human studies outside the United States.

  • If a client didn't desire to do an early-feasibility medical device human study outside the United States, they would be a bad fit.

  • If clients were not doing animal studies, they would be a bad fit.

  • What happens when someone tries to do the above activity, and they fail?" They won't be able to move on to the next phase of their development (human validation of safety and efficacy).

  • If a company doesn't hire us, they risk facing costly delays in gathering human clinical data and unhappy investors. (problems/challenges).

What is the result of failing to do the above activities correctly? What happens to the company?

The most severe consequences that could occur if someone didn't hire us and didn't solve the problem we solve would be a lack of human clinical data, unhappy investors, and the liquidation of the company.

What does bioaccess™ do for its clients? What service or solution does bioaccess™ provide?

  • We provide clinical research services for our clients on medical devices in Latin America.

  • When a customer works with us, it's over at least three years. Our main activities with them are quickly finding motivated investigators, obtaining ethics and regulatory approvals, and quickly finding research subjects in Latin America.

  • Our solution's various features/components/stages are the search and selection of an investigator, ethics and regulatory approvals, and management of the study.

What happens when the above desire/result is achieved?

When our clients succeed, they can get fast, quality, and ethical clinical data from research centers in Latin America.

What can bioaccess™ share that shows it is credible and capable of solving the problem?

  • We’ve served 35+ customers

  • We have 15 years of experience

  • We’ve executed 35+ clinical trials

What interesting/insightful/informative information does bioaccess™ share with others to learn more about its services?

  • Articles: See here.

  • Video Content: See here.

  • Client Testimonials: See here.

What common objections does bioaccess™ receive from prospective clients?

  • When prospects see our solution and learn of our value proposition, they sometimes wonder if we can get their clinical study approved and get them research subjects within their projected timelines.

  • Sometimes, prospects confuse us with a Colombian company, but we are US-based. 

  • The most common reason prospects don’t buy from us is they haven't yet raised funds needed for their human studies, or they found another geography where they can get their studies approved faster than in any country in Latin America.

Previous
Previous

Navigating The Medical Device Clinical Trial Landscape in Mexico

Next
Next

Navigating the Medical Device Clinical Trials Landscape in Colombia