Mastering trial management

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

Configuration & Customization

  • Role based access permissions for stakeholders of the specific project only giving access on an as needed basis and protecting confidential information
  • Study Project Management grants users access to the Study and/or individual Investigational Trial Sites based on operational needs
  • Study configuration lists allow to define study-specific parameters
  • Real-time access allowing ongoing data analysis in accordance to the user’s areas of responsibility

Document Management

  • Template manager with a full set of MS Word and Excel templates for all relevant areas of clinical trial and project management with easy-to-use customization functionality
  • Integration of additional, sponsor or study-specific templates achievable with minimal effort
  • Full traceability of all document review and approval steps via workflows
  • Storage and accessibility of all document versions created inside or uploaded to InSIGHT in a document version history
  • Collaboration and information exchange between CRO and Sponsor on study documents in a shared library

Electronic Signature

  • Timely document signature loop completion and document authorization
  • A verification tool can be optionally employed to ensure that the document content did not change since signature loop was started

Project Tracking & Visualization

  • Interrelated trackers for numerous study aspects make multiple entries of a single data point obsolete
  • Visualization of KPIs via Study Dashboards comes with filtering function and allows management of risk by focusing on the data of interest including: Site Status, Subject Recruitment Status, Protocol Deviation Status, and Monitoring Visit Status

Global Contact Database

  • Our internal contact database that is accessible to SCOPE staff only has grown organically over the years and still grows daily
  • Facilitates identification of suitable investigational sites for your trial in a timely manner
  • Dedicated processes ensure that contact data updates requiring follow-up action are notified to affected projects

Collaboration & Planning

  • The Discussion Board allows open dialogue and exchange of experience between project members
  • The Announcements function keeps all selected parties up to date with the latest project news and developments
  • The Calendar supports full project scheduling
  • Alert and reminder functionality to support users in planning of daily working life

System Compatibility

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

Quality & Regulatory

  • Audit trail of data entry
  • Control of data quality (error input recognition)
  • GCP and 21 CFR part 11 compliance capable
  • Validated System

InSIGHT – the benefits at a glance

  • Complete data transparency for the project team throughout clinical trial for higher quality and safety
  • Individualized view of study information for study stakeholders, anytime, anywhere
  • Real-time access to project data
  • Configuration of study-specific parameters allows customization in accordance to the project´s needs
  • Elaborate Document Management system with multiple options for customization
  • Electronic Signature
  • 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 (regulatory approval status at country level, etc.)
  • Being a proprietary solution, we have full flexibility for future system development
  • Secure, access-controlled system keeping your individual study data separate and confidential, with access permissions for project team members only and on a need to know basis

InSIGHT allows facilitation of decision-making – knowing sooner, deciding better, and finishing faster.