U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

custom efficacy studies

WuXi AppTec’s experienced scientists can design customized efficacy studies across a broad range of disciplines to support your R&D, regulatory submission and marketing needs – providing the sophisticated, integrated, clinically relevant data you need to differentiate your product.

With exceptional expertise based on many years of testing experience, WuXi AppTec offers device manufacturers a comprehensive program of efficacy studies, from simple implant models to complex skeletal defect or wound creation.

Capabilities and Program Features

  • Full-service experimental design programs
  • Customized testing for each test article, with testing models to target specific product applications
  • Innovative surgical approaches to efficacy studies
  • On-staff veterinarians, veterinarian pathologists and toxicologists
  • Ability to combine efficacy and safety endpoints into single protocols
  • Capacity to link design requirements of in-vitro assay to surgical endpoints
  • Expert clinical isolate stock development through BSL-2
  • Industry recognition for strong GLP and research studies
  • Personalized, expert regulatory and consulting services available to support sponsors

Core Competencies

Included in our preclinical custom study capabilities are established programs in:

  • Antimicrobial Efficacy Studies – from in-vitro screening to biofilm quantification to in-vivoefficacy
  • Orthobiological Studies – safety and efficacy testing, including defect and repair studies
  • Wound Healing Studies – including acute, infected and diabetic models

For more details on available testing services, click here to access the Catalog of Services for Devices and Combination Products.