Getting to Know bioaccess®: LATAM MEDTECH CRO
Company Overview
Based in Miami, Florida, and expanding our scope across Latin America, bioaccess® is a distinguished Medtech contract research organization (CRO) dedicated to facilitating the clinical validation of medical devices for US companies in Latin America. With over 15 years of dedicated service in the Medtech sector, we specialize in navigating the complex regulatory environment, managing multi-center trials, and ensuring the success of medical device clinical trials. Our mission is to accelerate the process from early feasibility studies to market launch, offering Medtech startups affordable, high-quality clinical research solutions. Our comprehensive suite of services encompasses site and principal investigator selection, regulatory compliance, trial setup, and project management, aiming to overcome the logistical and regulatory challenges inherent in Latin American operations.
Success Factors
Our success is built on a foundation of extensive experience, with a team that brings more than 15 years of expertise, specializing in the Medtech sector. This specialization enables us to provide tailored solutions that address the unique challenges medical device companies face. We have established a robust network of top-tier clinical research sites and investigators across Latin America, coupled with effective recruitment strategies that contribute to our ability to offer cost-efficient clinical trial services. Our accomplishments include the successful management of trials for notable devices and securing rapid regulatory approvals, a testament to our efficiency and the value we bring to our clients. Our recognition by the U.S. Commercial Service and testimonials from top companies underscores our leadership in the Medtech CRO space.
Industry Analysis
The clinical trials industry in the United States, valued at over $40 billion, is essential for advancing medical research and improving patient outcomes. The industry is on an upward trajectory with an expected annual growth rate of around 5%, driven by the demand for innovative medical solutions and technological advancements. The globalization of clinical research and a patient-centric approach align well with bioaccess®'s offerings. Specializing in serving US and European Medtech companies in Latin America, bioaccess® is poised to leverage these trends, offering unique value propositions for conducting medical device clinical trials in the region. The projected growth of the Latin America CRO market and the specific demand for medical device CROs in the area further highlight the significant opportunities for bioaccess®.
Customer Analysis
Our primary targets are Medtech medical device startup companies requiring early feasibility clinical trials to validate their innovations. At the nascent stages of development, these startups seek a reliable partner like us to navigate clinical research complexities. Besides startups, we also cater to established medical device firms aiming to expand their market reach by conducting trials in Latin America. Our deep regulatory knowledge and efficient trial processes offer these companies faster approval timelines and broader market access, aligning with their strategic goals. Our ability to conduct quick, cost-effective research in a diverse patient population positions us as an ideal partner for international Medtech companies looking to enrich their global clinical trial portfolios with Latin American sites.
Competitive Analysis
bioaccess® distinguishes itself from competitors like RARAS CRO, ACTIVA CRO, and Cohortias by focusing exclusively on the Medtech sector. This specialized approach provides us with a more profound understanding of the unique challenges and opportunities within this sector, delivering tailored solutions that cater specifically to the needs of Medtech companies. Our expertise in early feasibility clinical trials, essential for Medtech innovations, enables us to offer valuable insights and streamlined processes, thus accelerating our clients' paths to market. Our presence in Latin America also grants access to diverse patient populations and a more accommodating regulatory environment, further enhancing our competitive edge.
Marketing
bioaccess® offers a suite of specialized services designed for the unique landscape of medical device clinical trials in Latin America, including site and principal investigator selection, study document review for regulatory compliance, trial setup, and approvals, and logistics management for investigational devices. Our project management and monitoring capabilities ensure trials progress efficiently, supporting our clients throughout the trial process. Our marketing efforts highlight these comprehensive services and our track record of success in attracting Medtech startups and established firms. Promotions leverage digital marketing, industry conferences, and partnerships to reach our target audience, emphasizing our cost efficiencies, speed to market, and regional expertise to differentiate our offerings.
Operations
To achieve operational excellence, bioaccess® adheres to key daily processes, including compliance with regulatory standards, continuous communication with stakeholders for smooth operations, skilled team recruitment and management, and robust data management systems. We focus on detailed project planning, quality control, effective budget management, and innovative patient recruitment and retention strategies. Our strong relationships with healthcare providers, cutting-edge technology usage, and commitment to continuous improvement and innovation are crucial for delivering high-quality services and maintaining our competitive edge. Regular training and market trend monitoring ensure our team and services remain at the forefront of the industry.
Management Team
Our management team comprises seasoned professionals with extensive Medtech and clinical research experience. Their expertise spans regulatory compliance, project management, medical device innovation, and global market strategies. This diverse skill set ensures that bioaccess® is well-equipped to meet the complex demands of medical device clinical trials and navigate the regulatory landscapes of Latin America effectively. Our leaders are committed to fostering a culture of excellence, innovation, and customer satisfaction, driving the company's vision forward, and securing our position as a leader in the Medtech CRO industry.
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?
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.
