Challenge

The client needed to design and implement processes as part of a RIM transformation initiative.

Solution

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.

Impact

Orion improved process efficiency by 30%, ensured end-to-end visibility of data and fine tuned the process for Veeva configuration.

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