StudyARCHIVE

EDC system for flexible recording

of data.

Study ARCHIVE

EDC system for flexible data acquisition.

StudyARCHIVE | EDC system

Collect project data digitally, alone or decentrally with colleagues, electronically.

 

“StudyARCHIVE” is an EDC system for the flexible collection of data. This can be data from research projects or study projects or data from surveys. The system can be easily configured for (multiple) project content and offers functions for quality assurance and visual database queries.

EDC system | Quality Software | Modern solutions for your laboratory | Structured and sustainable processes |
Extensive services | Tailor-made overall concepts

General properties

StudyARCHIVE

Data entry

  • Self-configurable input masks
  • Easy integration of routine data
  • Export function: Excel, Word, PDF, XML, CSV
  • Data export based on filter
  • Import functions: XML, CSV
  • Easily duplicate records
  • Standard catalogs (e.g. ICD-10, red list, OPS) and the option of defining your own catalogues
  • Data filters and tags

Mobility

  • Can be integrated into any infrastructure because it is web-based
  • Can be used regardless of location
  • Can be used on the go with a tablet + Bluetooth scanner

Team work

  • Multi-tenant
  • Calendar and document management
  • Share studies and projects with other centers
  • Guest Access Features
  • Internal communication system (optional)

Compliance

  • Compliant GDPR
  • Compliant with EU GMP Annex 11
  • Compliant with FDA 21 Part 11

Data security

  • User Roles and Access Rights
  • Individual input masks depending on the user
  • Audit Trail (traceability of all activities)
  • Pseudonymisation service (PSD), the PSD encrypts sensitive data in accordance with ISO standard 25237 and the data protection concept of the TMF – technology and method platform for networked medical research
  • Encrypted data transmission via SSL certificate
  • Separation of data areas on 4 databases
  • Timestamp per record

Special properties

StudyARCHIVE

Studies and projects

  • Design data masks for any project yourself.
  • Individual input masks depending on the user
  • Monitoring function / query system (optional) to validate data entry.
  • Graphic guidance system to the source of the error.
  • Design projects individually for each user and right.

Query Builder

  • Possibility to query all database fields (combined).
  • Graphic representation of the queries
  • All queries can be saved
  • Export function: Excel, Word, PDF, XML, CSV

Quality control

  • Create your own help system and store documentation instructions
  • Securing of data entry through digital signature according to the 4-eyes principle.

Make an appointment now

We would be happy to show you our EDC system in a webinar without obligation or offer a free initial consultation.

 

Contact us!