MACRO

Advanced data collection for clinical research

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Customers value MACRO Electronic Data Capture (EDC) for its data integrity, data management and compliance. MACRO's easy-to-use system allows users to quickly input, monitor and run reports on subject data to collect accurate and reliable data for analysis

MACRO is a trusted trial resource. Staff and software are audited according to Good Clinical Practice (GCP), demonstrating that they conform to internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials involving human subjects. MACRO users can rest assured that the rights, safety and well-being of trial subjects are protected and that the results of the clinical trials are credible and accurate.


Compliance & Audit
Successfully audited by the MHRA and compliant with ICH Good Clinical Practice 
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Customer Support & Training
Friendly, responsive support team plus training courses, help and videos to get you up and running 
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Data Entry
Instant response validation and derived values for quick, easy data collection 
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Data Management
Reports and event-driven alerts, data verification, clarification, import & export  
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Study Design
Drag and drop form designer, re-usable libraries, conditional elements and question validation
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System Management & Security
Manage databases, studies and user accounts and monitor system activity 
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Read how Elsevier’s MACRO team worked with ABCSG to support staff at sites globally in delivering consistent and high-quality data.

Delivering electronic data capture for a clinical trial in breast cancer

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Features

Find out more about the features MACRO offers

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 multi-national 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