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…
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.
You have an innovative medical device or drug, and you need an organization experienced in getting products approved and on the market.
Hermes Creative Awards
Proxima Clinical Research Honored by Hermes Creative Awards
Proxima CRO recognized with two platinum awards, two gold awards, and five honorable mentions for its creative branding, marketing, and videos by Hermes Creative Awards, an international competition recognizing the work of creative professionals.
FDA Issues Breakthrough Device Certification for Proxima Client Sigi™
Sigi™ provides a modern solution in the treatment of diabetes mellitus. It is the only insulin patch pump for closed loop integration designed for use with standard, pre-filled pump cartridges. Sigi™ can be programmed to deliver basal and bolus insulin at both set and variable rates via a Bluetooth-compatible continuous glucose monitors or alternative controller devices such as a smartphone or an iController.
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.
Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium that includes Baylor College of Medicine, Texas Children's Hospital, Texas A&M University, Rice University, University of Houston, and Fannin Innovation Studio. SWPDC is supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.
Chester J. Koh, MD
Physician
“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
We have had the pleasure of working with Isabella Schmitt and Andrew Frink for over a year on overall regulatory strategy and support for FDA interactions. Isabella, Andrew, and the entire Proxima team are unbelievably knowledgeable in this space with excellent communication skills, highly strategic thinking, and amazing customer service. We at Prenosis highly recommend them as a one stop shop for anything regulatory or clinical trial related, all offered at a very attractive price point.
