The client needed to design and implement processes as part of a RIM transformation initiative.
Orion managed process design for RIM transformation by defining end-to-end RIM processes that encompassed R&D planning, regulatory requirements, and safety and change controls. Orion provided the following services:
- Designed/redesigned and harmonized 15 RIM processes: for e.g., Regulatory, Safety, CMS Change Control, and Correspondence/Commitments
- Facilitated workshops and business/data/reporting requirements through analysis sessions
- Documented process narratives, business and data requirements
- Defined operating model processes for ongoing operations, data quality monitoring, governance, etc.
Orion improved process efficiency by 30%, ensured end-to-end visibility of data and fine tuned the process for Veeva configuration.