Ennov CLinical suite
MACRO
Clinical Trial Management Software
- Compliant with ICH Good Clinical Practice
- Friendly, responsive support team
- Instant response validation for quick and easy data collection
- Data validation, clarification, reports and alerts for smooth data management
- Cloud-based or on-site installation to suit your infrastructure
MACRO EDC
The MACRO Advantage
MACRO EDC is valuable to customers because of the data integrity, data management and compliance features it provides. MACRO’s easy-to-use system allows users to quickly enter, track and report on subject data to collect accurate and reliable data for analysis.
Staff and software are audited in accordance with Good Clinical Practice (GCP) to demonstrate compliance with internationally-accepted ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials involving human subjects. MACRO users can be assured that the rights, safety and health of their trial subjects will be protected, and the results of their clincial trials will be reliable and accurate.
MACRO is suitable for studies at all clinical trial phases, and is scalable for any size experiment. It can be used by small, medium or large organisations for single-site studies and multi-national trials.
MACRO Features
Compliance and Audit
- Successfully audited by MHRA
- Compliant with ICH Good Clinical Practice
- Compliant with EU Clinical Trial Directive and Drugs for Human Use Regulations
- Compliant with FDA 21 CFR Part II
- ISO27001 certified data center
- Audit log and audit trail
- Double timestamps
Study Design
- Drag and drop form design
- 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
- Instant validation of values during data entry
- Re-evaluation of validation checks at enrollment
- 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
- A choice of export formats including SPSS, SAS, STATA and CSV
- Integrated data clarification and source data validation processes
- Flexible database locking features
- Data import and export
- Data archive
- Event-based rules and automated alerts
System Management and Security
- Create, save and manage databases
- Use permission sets to define flexible user roles
- Assign user roles for each study and site combination
- Set password properties
- Flexible timeout
- Monitor system activities
- Built-in browser technology protects data in transit and includes secure socket layer encryption and digital signatures
- Powerful API for integration with your systems
Customer Support
- Service Level Agreement four hour response to critical issues
- Comprehensive help system
- Demo videos for new features
- Face-to-face training
- Online customer group for sharing best practices
- Annual User Group meeting
Customer Support: https://extranet.ennov.com
Ennov Clinical
The Ennov Clinical suite consists of Clinical Data Management applications (EDC, RTSM and ePRO) as well as Clinical Trial Management applications (CTMS and eTMF) that are available for deployment in the cloud or on premises.
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov
Over 20 Years of experience providing software solutions for Life Sciences
250+ life science customers, many more in other industries.
Modern architecture and interface
100% web-based. Highly scalable. User-centric design.
Our commitment to your success
Very high customer satisfaction, 98.5% of projects delivered on time and within budget.
Providing you freedom of choice
Available as cloud-based or on-premises deployment
You can switch between deployment options at any time.
We make you autonomous
System configuration and management require no IT skills.
Improved security and optimized performance
Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
