We supported the initiation of clinical trials for a client conducting their first trial in Japan. We provided comprehensive support for tasks necessary for trial preparation, including the creation of the trial protocol, PMDA consultation and response to inquiries, SOP development, CRO selection and auditing, among others. Our assistance aimed to ensure the quality of the trial, facilitate a smooth trial initiation, and continue support post-trial launch, including CRO management.
We provided support in IT strategy for a new product launch for a client conducting PMS work for the first time in Japan. We developed a risk management plan, provided PMDA consultation, handled inquiry responses, created implementation plans, made considerations for survey items, created analysis plans, assisted withCRO selection, and other tasks. Additionally, to streamline the progress of PMS, we assisted in establishing necessary tools and processes on the pharmaceutical company’s side.