Clinical Contract Research (Pivotal Trials and Post-marketing Studies)
AlcheraBio has qualified, permanent, in-house staff to conduct clinical trials in the United States and Europe under Good Clinical Practice (GCP) guidelines, including data management and Quality Assurance. We can support target animal safety studies, and provide guidance for other technical sections required by the FDA Center for Veterinary Medicine. AlcheraBio also provides guidance on approvals by other regulatory agencies (USDA, EPA), and we are now able to conduct studies in Europe in collaboration with Dr. Marie-Paul Lachaud-Lefay, a well-known expert in veterinary contract research. To learn more about Dr. Lachaud-Lefay, click here.
AlcheraBio also conducts and supports post-marketing (Phase 4) studies.