MACRO Features

Compliance & Audit

  • Successfully audited by MHRA
  • Compliant with ICH Good Clinical Practice
  • Compliant with EU Clinical Trial Directive and Medicines for Human Use (Clinical Trials) Regulations
  • ISO27001 certified data centre
  • FDA 21 CFR Part 11 compliant
  • Audit log and audit trail
  • Double time stamp

Customer Support

  • Four-hour SLA response
  • Email and phone support
  • Extensive help files
  • Demo videos for new features
  • Face-to-face training
  • Online customer forum for sharing best practice
  • Annual User Group

Data Entry

  • Online and offline data entry
  • Immediate validation of values during data entry
  • Re-evaluation of validation checks on saving
  • Automatic calculation of derived values
  • eSignatures and approvals
  • Alerts, prompts and reminders
  • Visual status overview
  • Clinical coding with MedDra integration
  • Remote data entry

Data Management

  • Pre-defined and custom reporting
  • Multiple export formats including SPSS, SAS, STATA and CSV
  • Integrated data clarification and source data verification processes
  • Flexible database lock features
  • Data import
  • Fully compliant data archive
  • Event-driven email alerts

Study Design

  • Drag and drop form design
  • Full control of page layout
  • Build your own library for easy re-use
  • Conditional activation of visits, forms and questions
  • Advanced calculations and derivations
  • Flexible and powerful edit checks
  • Test and training environments
  • Supports all trials from Phase I to IV, scaling from a single site to large multinational trials
  • Allows for all standard question types plus laboratory normal ranges, inclusion of attachments and clinical coding of responses
  • Repeating question groups (tables)

System Management & Security 

  • Create, register and administer databases
  • Define user roles comprising sets of permissions
  • Assign user roles per study and/or per site
  • Specify password properties and assign/change passwords
  • Monitor system activity
  • Set minimum and maximum password length and password expiry period
  • Timeout period before repeat log-in is required
  • Built-in browser technology for protecting data during transfer, including secure socket layer encryption and digital signatures