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Enhance and Modernize Clinical Regulatory Information Management Platform for Scalability and Compliance
  1. case
  2. Enhance and Modernize Clinical Regulatory Information Management Platform for Scalability and Compliance

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Enhance and Modernize Clinical Regulatory Information Management Platform for Scalability and Compliance

nix-united.com
Health & Fitness
Information technology
Medical

Challenges with Legacy System and Evolving Regulations

The client's existing Regulatory Information Management (RIM) platform, built on a legacy Java 7 architecture, faces challenges in adapting to constantly evolving global regulatory requirements (FDA, EMA, PMDA, etc.). The inflexible architecture hinders timely updates, increases maintenance costs, and limits scalability to meet growing demands. The current ticketing and monitoring systems (Salesforce, HP Quality Center, ServiceNow, Dynatrace, AppInsights) require further integration and optimization.

About the Client

A leading global provider of technology solutions for clinical trial processes in the pharmaceutical industry, specializing in regulatory information management.

Project Goals

  • Modernize the RIM platform architecture to improve scalability and maintainability.
  • Enhance regulatory compliance capabilities across multiple regions and standards (FDA, EMA, ICH, etc.).
  • Improve IT support efficiency through streamlined ticketing and automation.
  • Increase system performance and reduce downtime.
  • Enhance data integration capabilities with external systems (Oracle, Documentum, etc.).
  • Improve user experience and satisfaction with the support system.

Functional Requirements

  • Automated submission workflow management.
  • Regulatory document management and version control.
  • Compliance tracking and reporting.
  • API integration with external systems.
  • Advanced search and reporting capabilities.
  • Self-service portal for common IT issues.
  • Automated ticket routing and escalation.
  • Knowledge base integration for faster problem resolution.

Preferred Technologies

Azure
Spring Framework
Microservices Architecture
JavaEE
ServiceNow
Oracle
Power BI

Required Integrations

  • Oracle Databases
  • Documentum (Document Management)
  • Samba Cloud Storage
  • Corporate LDAP

Key Non-Functional Requirements

  • High Scalability
  • High Performance
  • Robust Security
  • High Availability
  • Compliance with Industry Regulations (FDA, EMA, etc.)
  • Comprehensive Audit Logging

Expected Business Impact

This project will result in a more scalable, compliant, and efficient RIM platform, accelerating drug approvals, reducing operational costs, and improving overall business agility. The enhanced IT support system will lead to increased user satisfaction and reduced downtime, contributing to the client's continued success as a market leader in the clinical trial technology space. Improved compliance will minimize risks and penalties associated with regulatory violations.

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