secuTrial® | Moduls

Structured and user-friendly.


  • Management of separate customer areas
  • Release of administrators and project schemas
  • Release of basic application functions
  • Documentation of database schema
  • Software update history


  • Independent creation of form setup including database (automatic generation of database structure and data model)
  • Creation of the eCRF (visit plan, form families, forms, items and help texts)
  • Specification of online checks and plausibility tests (format errors, interdependencies, value thresholds, completion, adopted values and simple scores)
  • Specification of additional study parameters (electronic signature, AuditTrail, documents, randomization, qualification test)
  • Visit plan configuration
  • Flexible configuration settings (e.g. eSignature, source data verification, data entry workflow and monitoring)
  • Configuration of reports and statistics for displaying typical overviews
  • Quality assurance and setup with separate test area
  • Change management with versioning of the form setup and all configuration settings
  • Comprehensive automatic documentation of the database and all versions of the study setup


  • Central management of participants (assignment of passwords), centres, roles and patients
  • Parameterisable role and rights system (defined generally and on a form-related basis)
  • Patient management
  • Patient limiting option (recruitment per participant)
  • Participant management (projects, centres, locations)
  • Editing of the study-specific layout
  • Independent layout management for each project/customer
  • Incremental AuditTrail
  • Activity log for participants and patients
  • Automatic password assignment facility
  • Individual language setting can be defined for the user interface
  • Option to define a preferred patient overview


  • Complete web-based entry of patient data
  • Study inclusion and pseudonymisation of patients
  • Option to use own pseudonyms
  • Medical data recorded in accordance with the study protocol via eCRF
  • Scalable eSignature
  • AuditTrail for recording all changes to medical data
  • Role-dependent query management
  • Online monitoring with query dialogue
  • Up-to-the-minute reports for a quick overview of study progress and data capture statu
  • Statistics for displaying typical overviews
  • (Serious) adverse events workflow (optional: automatic fax and/or e-mail notifications)
  • Automatic messaging system for adverse events and exceeded value thresholds (optionally also via e-mail)
  • Patient status (e.g. if patient consent is withdrawn)
  • Patient and data import
  • Importing of image data (e.g. DICOM, jpg, gif, png, avi, mpg)
  • Source data verification for reliable data entry
  • All forms for a patient summarised in a printable patient file, also as a PDF
  • Double data entry
  • Patient Reported Outcome
  • Flagging of missing values


  • Pseudonymisation of personal data in compliance with data privacy regulations
  • Identifying data on paper or via external database
  • Linking with the Mainzelliste


  • Export patient data from the database
  • Supported export formats: CSV, SAS, SPSS, CDISC-ODM and TXT
  • Asynchronous generation with e-mail notification upon completion of the export
  • Search/filter function with dynamic search forms
  • Role-based access rights
  • Export protection via TAN
  • Search/export history
  • Option for automated export triggering
  • Creation of individual export templates