General Surgery

On the cutting edge of surgical advancement

General surgery research is responsible for some of today’s most important drugs and devices. Research and development in this field remains innovative and therefore, requires an experienced team.

Proxima’s strategic experts are ready to support our sponsors with their products ensuring success and speed.

expertise

Experience

Expertise where it counts

The following represents a summary of our surgical experience.

Investigational Products:

Biologics
Electrical Stimulation for Wound Closure
Growth factors
Scaffolds
Dermatology; Tissue Scarring
Surgical Hemostasis
Soft Tissue Surgical Closure
Vascular
Hepatic
Spinal

Indications:

Scarring
Bleeding Control and Monitoring
Wound Care: Venous and Diabetic Healing and Closure
Peritoneal Adhesion
Ostomy Closure
Breast Reconstruction
Vascular, Hepatic, Spinal closure
Trauma

EXpERIENCE

Our team is experienced with:

Regulatory Support
510(k)
PMA
IND
BLA
Combination Product
Trial Design and Strategy Management
Project Management
Safety Management
Data Collection and Analysis
Health Economics
CRF Design
Database Configuration
Reporting
Reimbursement and Payor Support
Medical Affairs
Site and Patient Payments and Contracts
Quality of Life (QoL) & Patient Reported Outcome (ePRO)
Vendor

Fusion Rates and Quality

EQ-5D, SF-12, SF-36, VAS, HHS, KOOS, WOMAC

HRQOL

HEALTH ECONOMICS

Endpoint adjudication Committees

RCT

Power Calculations, Randomization Ratio, Blinding, Cohort Arms, Choice of Control Procedure, and Rate of Crossover, Dropout, and Missing Data

Outcome measures

Time Points, Primary Composite Endpoint, Secondary Endpoints, Surrogate Radiographic Endpoints, Choice of Clinical Instruments, and Time of Final Follow-Up.