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 where it counts
The following represents a summary of our surgical experience.
Investigational Products:
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  • 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
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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
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Fusion Rates and Quality
EQ-5D, SF-12, SF-36, VAS, HHS, KOOS, WOMAC
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HEALTH ECONOMICS
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Endpoint adjudication Committees
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RCT
Power Calculations, Randomization Ratio, Blinding, Cohort Arms, Choice of Control Procedure, and Rate of Crossover, Dropout, and Missing Data
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Outcome measures
Time Points, Primary Composite Endpoint, Secondary Endpoints, Surrogate Radiographic Endpoints, Choice of Clinical Instruments, and Time of Final Follow-Up.
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Ready to find out how Proxima can partner with your General Surgery teams?
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