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.
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.
We were entrusted with the implementation of Post-Marketing Surveillance, including the creation of implementation guidelines, survey forms, facility contracts, patient enrollment, data management, statistical analysis, medical writing, and system development (EDC, progress management systems, etc.). We established a project manager to centrally manage the outsourced tasks and implemented strategies for the smooth progress of the surveys. This included devising and executing measures to address issues (such as approaching facilities experiencing progress delays, implementing measures to control re-surveys, etc.), ensuring high-quality and efficient survey operations.
Through being entrusted with multiple Post-Marketing Surveillance projects from the same client, we implemented measures to streamline and expedite operations. This involved the construction of standardizing procedures, accumulating and sharing knowledge for inquiry management, and overall efficiency improvement. Additionally, we conducted comparative analyses of evaluation criteria for each survey (such as the collection period for survey forms and re-survey forms), identified challenges, and implemented measures. This approach ensured a smooth progression of surveys.
We supported the implementation of EDC and peripheral systems (reporting systems, data export tools, etc.). From planning validation plans, requirement definition, configuration design, OQ, UAT execution to operational design, we facilitated the entire implementation process. We continued to provide support after the start of actual operations, assisting in database construction and system operational management.
We have conducted support for the implementation of a safety information system and the development for periodic reports. We acted as project managers and business analysts, contributing to project planning, requirement definition, configuration design, CRP, UAT support, and overseeing and driving the entire process, including training. As the system development was outsourced for offshore development in India, we also coordinated and managed the offshore team.
We have conducted project management and business analysis support for the implementation of a Track & Trace system. This involved designing business workflows for each export destination, leading and coordinating with overseas vendors and client companies, providing support for validation activities, creating system usage manuals, conducting user training, and handling post-implementation maintenance support.