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 OR click here to access a collection of PDF literature available for viewing and printing.