International
Pharmaceutical Company
Optimizing the Clinical Development Business Process Model and transfer to a web-based Solution
- The customer started a project to update and align the process model of clinical development to the recently reorganized structures.
- For this purpose, the procedural, functional and organizational changes had to be transferred into the current process model.
- In addition, the process model was to be transferred into a more comprehensive IT tool that allows intuitive navigation and can be accessed by employees worldwide.
- Reviewing and optimizing Clinical Development processes, considering regulatory requirements.
- Documenting the optimized core processes on four levels (process landscape, main processes, sub-processes, description of activities).
- Supporting the transfer of the process documentation to the group-wide content management system, including ensuring the navigation between the various description levels and linking to important appendices (standard operating procedures, work instructions, role profiles, checklists, templates).
- Optimized Clinical Development processes that also meet current regulatory requirements.
- Clear, web-based and fully navigable process model of Clinical Development on four description levels.
- Worldwide availability of the process flows including the essential supporting documents.
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