Translating Strategic Goals into Operational Excellence
| Strategic Pillar (Goal) | Key Challenge Cited in Workshop | DnxtSolutions Value Proposition |
|---|---|---|
| Operational Scalability | No systematic approach to answer agency questions (RTQ Management). | Implement Robust RTQ Infrastructure: Define workflows, triage, and response standards to ensure timely approval and a robust, scalable process. |
| Data as a Strategic Asset | Data fidelity issues and lack of a single source of truth (Veeva RIM). | Ensure RIM System Integrity: Execute Comprehensive End-to-End QC and design the RIM Governance and Operations infrastructure to fix data fidelity and compliance certainty. |
| Organizational Adoption | Change management is challenging; high variability in processes (e.g., CTA archiving). | Drive Strategic User Adoption: Translate Affiliate Onboarding logistics into a successful User Adoption lifecycle, reducing manual efforts and driving high utilization. |
🤝 Focusing on Adoption: From Onboarding to Utilization
The success of the entire regulatory roadmap hinges on users across the organization adopting the new Veeva RIM system and processes, a challenge explicitly noted as difficult due to user behavior.
| Area of Support | Project Objective Addressed | DnxtSolutions Deliverables |
|---|---|---|
| Process & Standardization | Establish Veeva RIM Infra: Process & Training. | Process Redesign & Documentation: Upgrade and standardize existing process documents (SOPs/WIs/Job aids) to ensure consistency and quality of data and reduce rework. |
| Change Management | Team and Team Member Development. | Customized Training Strategy: Design the Training solution strategy, plan & materials and create a change management plan focused on showing users how the system “will make your life easier”. |
| Sustained Support | Veeva RIM Support Program (RegOps Office Hours). | Centralized Support Model: Establish the Issue management (intake, triage, escalation, resolution) strategy to eliminate the high volume of one-off emails and position RegOps as the primary POC for support. |
| Expertise Building | Eliminate silos and cross train. | Targeted Expertise Deployment: Define the strategy for deploying “super users in the affiliates” versus maintaining centralized roles to build functional expertise and bench strength. |
📈 DnxtSolutions Angle: Maximizing Regulatory Value
Your organization seeks to leverage systems and processes across regulatory deliverables and demonstrate clear value. DnxtSolutions is the partner that provides the expertise, capacity, and structured execution to turn your strategic vision into quantifiable success:
- Mitigate Project Risk: We step in to manage high-visibility, “At Risk” projects like the NDA/MAA Submission Management, ensuring critical timelines are met.
- Establish Repeatable Processes: We build the repeatable, documented, and trained infrastructure (RIM, RTQ, Archival) that enables the organization to scale for future affiliate and submission needs.
- Free Up Internal Capacity: By providing expert PM, process design, and change management resources, we free up your limited capacity and bandwidth to focus on core Regulatory Affairs strategy.
