MACRO

MACRO is a comprehensive clinical trial management system designed to streamline trial oversight, site management, and operational control. It is compliant with ICH Good Clinical Practice, ensuring that the rights, safety, and well-being of trial subjects are protected, and the trial's results are accurate and reliable. This system is suitable for all clinical trial phases and is scalable to fit studies of any size, from small single-site studies to large multinational trials.

The software's features include a user-friendly interface for quick data entry, tracking, and reporting on subject data. By ensuring data integrity and management, MACRO integrates necessary compliance features to support ethical and scientifically-sound clinical trials. Additionally, the platform allows for cloud-based or on-premises deployment, offering flexibility according to your infrastructure needs.

MACRO Features

• Drag-and-drop form design with full layout control
• Conditional activation of visits, forms, and questions
• Instant value validation during data entry
• Automatic derived value calculations
• Comprehensive audit trails with double timestamps
• Secure data with built-in browser technology and SSL encryption
• Integration APIs for system interoperability

The system supports robust data input with integration for clinical coding with MedDRA, and offers extensive management capabilities such as predefined and personalized reporting, flexible database locking, and event-based automated alerts.

MACRO includes comprehensive system and security management, featuring flexible user role permissions, password configuration, and monitoring of system activities to ensure data security. It provides a range of customer support options, including a four-hour response time for critical issues and extensive training resources.

Overall, MACRO delivers a reliable, scalable solution for capturing and managing clinical trial data efficiently, backed by over 25 years of experience in life sciences software solutions.