MACRO EDC

Clinical trial data capture, validation, and management with ICH GCP compliance and audit-ready operations.

Solution by Ennov

Overview

MACRO EDC, developed by Ennov, is a comprehensive Clinical Trial Management Software designed to provide one unified system for trial oversight, site management, and operational control. It is suitable for studies at all clinical trial phases and is scalable for any size of experiment, making it an ideal solution for small, medium, and large organisations conducting single-site studies or multi-national trials.

MACRO EDC is built around data integrity, data management, and compliance, enabling users to quickly enter, track, and report on subject data to collect accurate and reliable information for analysis. Staff and software are audited in accordance with Good Clinical Practice (GCP), ensuring compliance with internationally accepted ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects.

Compliance and Audit

Successfully audited by the MHRA
Compliant with ICH Good Clinical Practice
Compliant with the EU Clinical Trial Directive and Drugs for Human Use Regulations
Compliant with FDA 21 CFR Part II
ISO 27001 certified data centre
Full audit log and audit trail with double timestamps

Study Design

Drag and drop form design with full control of page layout
Build your own library for easy re-use of study elements
Conditional activation of visits, forms, and questions
Advanced calculations and derivations
Flexible and powerful editing controls
Test and training environments
Repeating question tables
A range of question types and laboratory normal ranges

Data Input

Online data entry with instant validation of values during entry
Re-evaluation of validation checks at enrolment
Automatic calculation of derived values
e-Signatures and approvals
Alerts, messages, and reminders
Visual status overview
Clinical coding with MedDRA integration

Data Management

Pre-defined and personalised reporting
Export formats including SPSS, SAS, STATA, and CSV
Integrated data clarification and source data validation processes
Flexible database locking features
Data import, export, and archive capabilities
Event-based rules and automated alerts

System Management and Security

Create, save, and manage databases with ease
Use permission sets to define flexible user roles, assignable per study and site combination
Configurable password properties and flexible timeout settings
Monitor system activities across the platform
Built-in browser technology with secure socket layer encryption and digital signatures to protect data in transit
Powerful API for integration with third-party systems

Customer Support

Service Level Agreement with a four-hour response to critical issues
Comprehensive help system and demo videos for new features
Face-to-face training options
Online customer group for sharing best practices
Annual User Group meeting

MACRO EDC is part of the broader Ennov Clinical suite, which includes eTMF, CTMS, EDC with ePRO, and RTSM. The platform is available as a cloud-based or on-premises deployment, with the flexibility to switch between options at any time. System configuration and management require no IT skills, and single-tenancy hosting minimises business interruptions. Ennov brings over 25 years of experience serving 450+ life sciences customers, with 98.5% of projects delivered on time and within budget, and holds both ISO 9001 and ISO 27001 certifications.