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
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.