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Digital Platform for Clinical Trial Operational Efficiency Enhancement
  1. case
  2. Digital Platform for Clinical Trial Operational Efficiency Enhancement

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Digital Platform for Clinical Trial Operational Efficiency Enhancement

robosoftin.com
Medical
Information technology
Business services

Clinical Trial Process Bottlenecks

The client faced significant delays in clinical trial operations due to legal/contract bottlenecks and lacked effective tools for global site-level decision-making regarding budgets, contracts, and informed consent forms (ICFs). They needed to improve collaboration with Contract Research Organizations (CROs) while achieving measurable business impact.

About the Client

Leading pharmaceutical company focused on accelerating clinical trial processes and improving partnerships with research organizations

Operational Transformation Goals

  • Eliminate legal/contract bottlenecks in clinical trial processes
  • Create standardized digital workflows for global site-level decision-making
  • Enhance partnership effectiveness with CROs through transparent collaboration tools
  • Implement agile development methodology with continuous user feedback

Core System Requirements

  • Digital contract lifecycle management system
  • Budget tracking and allocation dashboard
  • ICF (Informed Consent Form) management portal
  • Collaboration hub for sponsor-CRO communication
  • Real-time analytics for operational efficiency metrics

Technology Stack

Cloud-native architecture (AWS/Azure)
React.js for front-end interfaces
Node.js backend with microservices
Blockchain for contract security
AI-powered document processing

System Integrations

  • Existing CRO management systems
  • Electronic Data Capture (EDC) platforms
  • Contract management databases
  • Global compliance monitoring tools

Performance Criteria

  • 24/7 system availability with 99.99% uptime
  • HIPAA/GDPR compliance for data security
  • Horizontal scalability for global user base
  • Multi-language support for international operations
  • Disaster recovery with <15 minute RTO

Business Transformation Outcomes

The digital platform is expected to reduce clinical trial setup time by 40%, decrease contract negotiation cycles by 60%, and improve CRO collaboration efficiency through standardized digital workflows. Implementation of agile development practices will enable continuous improvement with 30% faster iteration cycles, while blockchain-based contract management will enhance security and auditability across global operations.

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