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Clinical Data Systems

At EMINENT, our Information Technology Team specializes in providing top-tier services for the comprehensive management of clinical data systems. These services are crucial for optimizing data integrity, security, and compliance with regulatory standards.

Key Services Include:

  • Systems Assessment: We evaluate your specific needs for data management and retrieval to ensure your systems are fully optimized for your requirements.
  • System Design and Implementation: Our team designs and implements robust data management systems tailored to the needs of your clinical trials.
  • Validation and Acceptance Testing: Rigorous testing is conducted to validate that systems meet all specified requirements before going live.
  • 21 CFR Part 11 Compliance: We ensure that all systems comply with FDA regulations for electronic records and electronic signatures.

Advanced Data Management Features:

  • Online Inventory Monitoring System: Real-time tracking of inventory levels to ensure adequate supply throughout the duration of your clinical trial.
  • Electronic Shipment Notification: Automatic notifications to clients and consignees about the status of shipments.
  • Online Shipment Request Status & Tracking System: A user-friendly online interface for monitoring the status of shipment requests and tracking shipments until delivery.
  • Automated Electronic Monthly Reports: Systems are set up to generate detailed monthly reports automatically, providing critical data at regular intervals.
  • Drug Recalls: Our systems are equipped to handle drug recalls efficiently, ensuring quick response times and minimal disruption.

Eminent’s expertise in clinical data systems extends beyond setup and implementation, encompassing continuous support and maintenance to ensure systems are always running smoothly and compliantly. Our IT solutions empower clients with the tools necessary for efficient management and oversight of their clinical data, helping to streamline operations and enhance decision-making processes.

Systems Overview at EMINENT

Eminent has developed and implemented a suite of sophisticated systems to streamline operations across various departments, ensuring efficiency and regulatory compliance in our daily operations. Here’s an overview of the key systems:

  • Investigational Drug Management System (IDMS): This system manages all aspects of investigational drug accountability, from receipt through dispensation, ensuring compliance with regulatory guidelines and enhancing drug supply management.
  • Laboratory Information Management System (LIMS): A comprehensive system designed to manage laboratory operations, data, and workflow. LIMS facilitates the efficient handling of large volumes of data, improving accuracy and traceability in laboratory processes.
  • Intranet-web for Document Management: This internal platform supports document sharing and management within EMINENT, enabling efficient communication and collaboration among staff. It helps in maintaining version control and ensures only the most current documents are in use.
  • Online Data Acquisition and Monitoring: This system is crucial for real-time data collection and monitoring, providing immediate access to data from clinical trials. It ensures data integrity and speeds up the decision-making process.
  • Purchase Order Processing System: Automates and streamlines the process of creating, approving, and tracking purchase orders, which enhances operational efficiencies and controls expenditure.
  • Automated Batch Record Generation: This system automates the creation of batch records, which are critical for maintaining compliance with Good Manufacturing Practices (GMP). It reduces manual errors and increases the speed of production cycles.
  • Disaster Recovery Plan: A robust system designed to ensure business continuity and minimize downtime in the event of a disaster. It includes data backups, system redundancies, and clear protocols for recovery operations.

These systems collectively enhance the operational capabilities of EMINENT, ensuring that we maintain high standards of quality and compliance while also responding swiftly to the dynamic needs of the pharmaceutical industry.

The following systems were designed and implemented for use in the daily operations at EMINENT.
  • Investigational Drug Management
  • Laboratory Information Management
  • Intranet-web for document management
  • On-line Data Acquisition and Monitoring
  • Purchase Order Processing
  • Automated Batch Record Generation
  • Disaster Recovery Plan

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