Our team provided support for a client facing increased workload on employees, project delays, and potential for project quality to suffer, as a result of an unforseen increase in surveys.We assembled a team of experienced professionals in data management, statistical analysis, and business systems. We provided comprehensive support, handling tasks that the client’s employees needed to address, CRO management (confirmation of re-survey details, coding support, review of analysis plans and reports, handling inquiries, etc.), coordination with other departments, and the construction and operation of business efficiency tools. As a result, tasks were carried out without delays, contributing to the improvement of quality and reliability in the PMS department.
The client’s safety management department had outsourced case processing to a CRO, but the pharmaceutical manufacturer faced numerous tasks on their end, leading to resource shortages. We provided inquiry handling support, developed safety management-related SOPs, advice on the configuration policy for safety information system, and assistance with validation activities, all sourced from the CRO. Through collaboration with the client, we achieved providing high-quality safety operations.
In the IT department of a foreign pharmaceutical company, securing bilingual IT project management personnel was challenging, leading to difficulties in the anticipated progress of system implementation. Our company facilitated project management for the localization of global systems (core systems, sales support systems, etc.) and the introduction of overseas package systems as an IT project manager. We successfully managed tasks such as summarizing Japanese requirements, conducting Fit&GAP analysis, communicating and coordinating with the global team, and controlling vendors. As a result, the system was implemented according to the originally planned schedule.