Sky Solutions

Modernizing Drug Review Processes for Transparency and Efficiency

Right Arrow IconBack to Success Stories

Overview

A federal health regulatory agency’s drug evaluation division sought to replace multiple legacy case management and review systems with a unified, scalable digital platform to enhance transparency, streamline drug review processes, and harmonize operations across offices. Sky Solutions developed a Proof of Concept (POC) for a next-generation regulatory platform using a low-code workflow solution hosted on a secure government cloud environment. The POC improved data transparency for over 1,500 users, simplified complex workflows, and reduced risks associated with aging systems—laying the groundwork for future innovation.

Goal

The primary goal was to build a modern, unified platform to enhance regulatory drug evaluation processes, improve data transparency for a large user base, and streamline workflows across the entire drug review lifecycle. The solution also aimed to reduce operational risks tied to legacy platforms, harmonize business processes across multiple internal offices, and provide a scalable foundation for future regulatory innovation.

Challenge

The drug evaluation division of the federal health regulatory authority is responsible for ensuring the safety and effectiveness of medications available to the public. To improve transparency, reporting, and operational efficiency, the division initiated a modernization effort to unify fragmented workflows spanning multiple offices.

This effort required replacing several legacy application tracking and review systems, including:
  • A document archiving, reporting, and regulatory tracking system used to manage and report on drug applications
  • A review and project management automation platform supporting regulatory workflows
A key challenge was ensuring that the new platform could support highly complex, interdependent workflows, handle transactional integrity, and meet the diverse operational needs of multiple program offices—all while minimizing disruption during transition from long-standing systems.

Solution

Sky Solutions designed and delivered a Proof of Concept (POC) for a next-generation regulatory platform to validate core system capabilities and establish a roadmap for full-scae implementation. Built on a low-code workflow platform hosted in a secure government cloud, the POC demonstrated end-to-end functionality for multiple drug application types.

The solution included:
  • A reusable workflow framework to support regulatory reviews
  • Role-based user access management
  • Defined deployment and governance guidelines
To address the complexity of atomic transactions, Sky Solutions implemented database-level stored procedures for transactional writes, while the low-code platform managed orchestration and business logic.

Technologies/Methodologies

  • Appian on GovCloud: Development platform for OneNexus
  • Oracle DB on Premises: Database solution
  • Microsoft SharePoint on Azure: Document collaboration tool
  • Atlassian Jira & Confluence: Agile project management tools
  • CDEROne Analytics: Integration for drug product details

Outcome

Sky Solutions successfully delivered the POC, receiving strong positive feedback from senior leadership within the regulatory division and accelerating momentum for the broader modernization initiative. Key outcomes included:
  • Enhanced data transparency for 1,500+ users
  • Streamlined and standardized drug evaluation workflows
  • Reduced operational risk through planned decommissioning of legacy systems
  • Improved process consistency and collaboration across internal offices