A SuperPowered CRO Joining Forces with Superpowered Clients
Together, we’re ready to save the world, one medical device or drug at a time. Come join us as the superhero saga continues…
You have an innovative medical device or drug, and you need an organization experienced in getting products approved and on the market.
We know your needs. We know the pitfalls of the submission process and how to avoid them. We’re here to make it happen— from concept to market.
MarCom Awards
Proxima Clinical Research among elite organizations receiving high honors from MarCom Awards
Proxima CRO is pleased to announce it has received two Gold Awards and an Honorable Mention by MarCom Awards during the 2021 International Creative Competition for marketing and communications professionals.
FDA Issues Breakthrough Device Certification for Proxima Client Trémedics’ Prenatal Stent
A stent for congenital heart disease developed for infants (30 days) to children up to 14 years by Proxima client Trémedics has received Breakthrough Device designation from the Food and Drug Administration (FDA).
Take our quiz for innovators to find out if your treatment is groundbreaking.
Is your device a breakthrough device? The FDA’s breakthrough device designation has many benefits for an emerging super-star company, such as yourself. Learn what defines a breakthrough device.
From regulatory consulting to clinical research, Proxima is a full-service Contract Research Organization
Proxima works with emerging biotech and medical device companies across all phases of development. As a contract research organization, we organize our team in two distinct areas: early stage advisory consulting and all-inclusive clinical trial services. The service you need. The speed you want. The attention you deserve.
“As a busy surgeon developing a Class III implantable device I needed help with regulatory strategy and execution. I wanted someone that was as passionate about the device as I was and that could hit the ground running. Because PROXIMA supports emerging companies through Med Tech Innovator they were a perfect fit. Isabella also helped us manage other vendor relationships and kept things moving forward. I been very happy working with PROXIMA”
Marc Bessler, M.D.
Founder
"Proxima has been attentive to a variety of our regulatory related needs. From coordinating studies with aggressive timelines to assisting with sales aid approvals, they have always delivered. As we launched our first in class/disease product, we needed a high touch clinical research and regulatory partner, and Proxima has provided that for us."
Robert Whitehead
Founder & CEO
"Proxima staff understood the needs of our company and took a vested interest in supporting our clinical trial’s aggressive timeline while safeguarding our goals and objectives. Proxima has been a true partner for our early stage medical device startup!"
