Therapeutic Areas: General Surgery

Cutting-Edge Clinical Research for the Surgeons Who Cut First

General surgery research is responsible for some of today’s most important drugs and devices. This rapidly evolving field demands continuous innovation, and an experienced clinical research partner with strategic expertise.

Proxima's team has the strategic expertise to support your surgical innovations.

Your Vision. Our Precision. Advancing Surgical Frontiers.

Proxima Clinical Research understands the complexities of surgical R&D.

Our experts reduce timeline risks, accelerating your speed-to-market.

Our Expertise Surgical experience

Navigating countless clinical trials

Proxima's experts guide sponsors' most ambitious surgical products

through every regulatory hurdle to achieve commercial success.

Our track record of success with companies innovating general surgery include:

Investigational Products:

Biologics

Dermatology; Tissue Scarring

Electrical Stimulation for Wound Closure

Surgical Hemostasis

Growth factors

Scaffolds

Soft Tissue Surgical Closure: Vascular, Hepatic, Spinal

Indications:

Scarring

Peritoneal Adhesion

Bleeding Control and Monitoring

Ostomy Closure

Wound Care: Venous and Diabetic

Breast Reconstruction

Healing and Closure

Vascular, Hepatic, Spinal closure

Trauma

Surgical experience

Our team is experienced with:

Regulatory Support: 510(k), PMA, IND, BLA‍

Health Economics

Combination Product

CRF Design

Trial Design and Strategy Management

Database Configuration

Project Management

Reporting

Safety Management

Reimbursement and Payor Support

Data Collection and Analysis

Medical Affairs

Site and Patient Payments and Contracts

Quality of Life (QoL) & Patient Reported Outcome (ePRO)

Vendor

"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."

Position

First & Last Name

Position

First & Last Name

“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”

Founder

Marc Bessler, M.D.

Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium 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.