CTMS

Clinical Trial Management System

Processing and storage of clinical trials specific data such as sites, investigators and subjects management
  • Feasibility assessment
  • EDC and IWRS integration
  • Investigators invoicing per visit

Workflows

Workflows Management

Optimization and automation of all processes in a company, for example, monitoring visits and pharmacovigilance.
  • Standardized processes on local and international level
  • Effectively-organized site visits
  • Safety information exchange with partners and authorities
  • Quick fields set up according to client’s specific requirements

PM & Budgeting

Project Management and Budgeting

Effective project planning and control, resource allocation including time sheets utilization and expense reporting
  • Project budget creation and tracking with ability to store different budget versions
  • Unlimited number of projects
  • Integration with other systems (MS Dynamics AX, NAV, GP)
  • Project planning in table and Gantt chart view
  • Project performance control
  • Separate cabinet for each project containing all project information from other modules

LMS

Learning Management System

Company’s training database helps to control personnel qualification level and their aptitude for job requirements
  • Training administration
  • Individual training plans tracking
  • Calendar integration and email notifications
  • Training materials view right in your browser window without need to download
  • Knowledge testing

TMF

Trial Master File

All project documentation is stored in one place with shared access
  • Easy access to all documents
  • Real time folders completeness statistics
  • Access control
  • Access through WebDAV
  • Document and folder approval process support
  • Folder structure templates
  • Adjustable change notifications

EDC & IWRS

Electronic Data Capture and Interactive Web-Response System

Reduced expenditures on randomization, drug supply and data management, and easy process stakeholders’ interaction thanks to electronic data capture and IWRS systems
  • High-performance data collection tool
  • Easy-to-use CRF building tool that does not require advanced technical skills
  • Secure data storage
  • 24/7 access to study data for all users
  • Data validation procedure support
  • All types of randomization and stratification
  • Effective drug supply management

Pharmacovigilance

PV System

Powerful tool for safety data management and reporting
  • Managing all PV processes within one system
  • Safety databases implementation
  • PV processes tracking
  • Reporting to regulatory authorities
  • Safety data exchange with partners
  • Easy-to-use system for managers
  • Data visualization, reports generation, statistics export
  • Data export in Excel, Word and PDF

Corporate portal

Corporate portal

Storage of information about clients and employees, project catalogue management
  • Time sheets completion and connection to project budget
  • Information about employees, on-line access to CV and job description
  • Client relationship management: from pre-sale to contract

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