To achieve that, we started with driving the redesign of the client’s GRA submission-related business processes and making them ready-for-integration in the new Vault RIM solution, with continuous oversight from a data and technology perspective.
We handled the project’s planning, management, communication and engagement tracking and brought in industry best-practices in line with Veeva Vault to ensure continuous improvement. Lastly, we delivered comprehensive Change Management and deployed training capabilities across all impacted functions and geographies.
Ultimately, we helped our client implement centralized regulatory content development and submissions, thus creating better interaction with internal and external stakeholders such as R&D teams and Health Authorities.
We put in place easy-to-understand and - use business processes that enable centralized governance and maintenance, and improve data quality to support reliable reporting and regulatory information. This allowed the implementation of relevant metrics and KPIs to measure efficiency gains and help identify improvement opportunities.