Informatics Governance Modernization

lanevis
  • Client Food & Drug Administration (FDA)
  • Scope PMO Modernization, Regulatory Process Automation, Informatics Governance, IT Infrastructure
  • Delivery August 2024 - Current

Summary:

Lanevis, LLC led a comprehensive transformation of program management office (PMO) operations and informatics governance at FDA CDER, significantly improving regulatory efficiency, data management, and decision-making. The project modernized CDER’s ability to identify, share, and utilize IT-related data by automating complex regulatory processes, implementing intelligent data standards governance, and deploying compliant, scalable IT infrastructure—all while maintaining alignment with FDA regulatory requirements.

Key Accomplishments:

  • Automation of Regulatory and Business Processes: Streamlined and automated CDER’s budget allocation and acquisition workflows, introducing intelligent contract management and vendor evaluation systems that enhanced procurement efficiency and transparency.

  • Financial Systems Optimization: Implemented real-time financial tracking tools that improved fiscal oversight, enabled proactive budget decision-making, and delivered measurable cost savings.

  • Cloud-Based Informatics Platform Deployment: Launched a modern informatics ecosystem supporting secure, cloud-based operations with 99.9% system uptime, enhancing scalability and operational continuity across CDER.

  • Automated Submission Processing: Introduced automation for IT use case triage, improving response time and prioritization accuracy by 40%.

  • Advanced Analytics for Strategic Decision-Making: Delivered robust data analytics capabilities that supported cross-office budget alignment and evidence-based planning at the enterprise level.

Outcomes:

Lanevis successfully transformed CDER’s PMO and informatics environment, driving measurable improvements in operational efficiency, fiscal governance, and regulatory workflow automation. Highlights include:

  • 40% improvement in IT use case triage performance

  • 99.9% uptime of deployed cloud platforms

  • Cost savings and procurement cycle reduction through intelligent automation

This engagement demonstrates Lanevis’s ability to deliver complex enterprise modernization initiatives that integrate automation, analytics, and regulatory compliance in support of high-impact federal missions.