PRECISE

PRECISE is a powerful, easy-to-use database driven, web based integrated management system. This central, comprehensive, electronically supplying environment, enables the users full visibility to trial management activities, administration, and trial related data and documents. The power to be well informed is the main focus and key concept of the PRECISE platform. The PRECISE platform is encapsulated in modules, which consider the needs of each department. The system offers amongst others the following modules:

Clinical trial Quality Management

  • Employee training file management
  • Company management
  • SOP management.
    • Versioning and tracking of SOPs and their related templates
    • Maintaining of SOP related training documents
    • Report functionalities

Clinical trial management

  • Trial administration (e.g.: Team administration and more) on different levels
  • Trial level essential documents pool
  • Trial level central share point for relevant information
  • Site administration
  • Site level essential documents pool
  • Site level central share point for relevant information
  • Site staff administration
  • Event and relevant information tracking on country, site, site staff and subject level
  • Monitor visit administration and documentation
  • Subject administration and tracking
  • Reporting on various levels
  • Essential documents pool
  • Knowledge Pool
  • Project responsibility management
  • Paper based CRF tracking
  • Data entry process administration and tracking

Regulatory Intelligence System for Clinical Trial Administration (CTA)

Country relevant information management:

  • Legislation
    • Laws
    • Guidelines
    • Forms
  • Fee
  • Required information and documents
  • Timelines for review regarding:
    • Answer of deficiency letters
    • Check of validity
    • Completion of CTA
    • Review of amendments
    • Review of CTA
  • Competent and local authorities
  • IECs

Country specific documentation review management