We bring extensive experience in hundreds of Phase I studies in the U.S. and China, including First in Human (FIH) studies. Our experience enables us to tailor our approach to each project. We offer a broad range of services geared towards accelerating the drug development process while maintaining quality. Our team’s experience and expertise enable us to provide our clients with the high-quality clinical development experience.
Our Phase I Unit, which is located in Chengdu, China is affiliated with Chengdu Fifth People’s Hospital. Our focus is on Phase I trials of innovative drugs, bioavailability, and bioequivalence studies. In July 2018, the unit became a certified clinical trial institution by the NMPA. Our center is fully staffed with full-time researchers, physicians, and nurses to ensure care is provided for patients. We have managed trials with normal healthy volunteers (NHV) and patients participating in endocrine, oncology, respiratory and geriatrics studies.
Through our partnership with Altasciences, we have first-hand access to five Phase I units across North America and are able to provide our clients a flexible, innovative approach to comprehensive early stage drug development from lead candidate selection to proof of concept. In addition, Altasciences established a partnership with WuXi AppTec’s Investigational New Drug (WIND) platform. WIND combines world-class CRO services with cross-functional program management and global regulatory expertise to support IND applications. Together, we provide full-service solutions, including clinical pharmacology, FIH and proof-of-concept trials to support and conduct comprehensive early phase clinical services.
Our primary service areas include:
- FIH single dose and multiple dose ascending study
- Pharmacodynamics (PD) and the parentheses
- Pharmacokinetics (PK)
- Drug-drug Interaction
- Confirmatory PK study to support China NDA for Category 3 drugs
- PK in Special Populations