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.