InSIGHT – CTMS

Mastering trial management

InSIGHT, our clinical trial management system (CTMS), is a powerful, integrated information platform that consolidates, standardizes and visualizes operational and clinical data from multiple sources to generate a holistic view of all study information through every stage. InSIGHT allows you to turn your data into real knowledge, supporting better and faster decision-making throughout the life of a trial.

Full system compatibility:

  • InSIGHT is fully compatible with MS Office, MS Exchange Server and MS Active Directory
  • Seamless and flexible integration with external data sources (electronic data capture, central labs, etc.) such as OData, WCF, Web 2.0 and DBMS (Oracle, MySQL, etc.)
  • Full integration with e-Solutions such as e-CRF, e-TMF, e-Diary, etc.

Monitoring and quality:

  • Full audit trail of data entry (user and time) and control of data quality (error input recognition) ensuring 21 CFR 11 compliance.

KPIs and risk management:

  • Inbound metrics (key performance indices) for risk-based monitoring
  • Cross-trial comparisons
  • Data can be displayed in a graphic format and filtered to fit user requirements.

Project management

KaleidoSCOPE and InSIGHT provide you with all the tools you need to streamline your workflow

Role-based access:

  • Real-time access allowing ongoing data analysis according to the user’s areas of responsibility.

Audit trail and versioning:

  • Full tracking of all document review and approval steps and processes.
  • Collaboration and scheduling:
  • The Discussion Board allows open dialogue between project members
  • The Announcements function keeps all selected parties up to date with the latest trial news and developments
  • The Knowledge Base allows users to write and publish articles internally using Scope’s own intuitive wiki system
  • The Calendar supports full project scheduling

Customization and configuration:

  • A full selection of MS Word-compatible templates for all areas of clinical trial and project management with easy-to-use customization functionality.

InSIGHT – the benefits

  • Complete data transparency throughout clinical trial for higher quality and safety
  • Individualized view of study information for study stakeholders, anytime, anywhere
  • Real-time access to quality data, critical safety data, efficacy data, performance metrics, etc.
  • Consolidation and standardization of data across multiple sources (operational, quality, efficacy and clinical safety)
  • Processing of data with reporting, analytical, and visualization tools, allowing study teams and sponsors to access live study information and trends
  • Continuous tracking and overview of operational activities and performance (e.g. regulatory approval status at country level; lab data status at subject level, etc.)

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