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
臨床試験情報の取得と管理のための包括的な
ソリューション
Ennov Clinical Suiteは、臨床データ管理アプリケーション（EDC、RTSM、ePRO）と臨床試験管理アプリケーション（CTMS、eTMF）で構成されており、クラウドまたはオンプレミスで展開可能です。
Ennovを選ぶ理由
Ennovを信頼する数百社の顧客企業
20年以上にわたるライフサイエンス分野におけるソフトウェアソリューションの提供経験
ライフサイエンス分野の顧客は250社以上、その他の業界も多数
最新のアーキテクチャとインタフェース
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お客様の成功のために
顧客満足度が非常に高く、98.5%のプロジェクトが期限内、予算内に納品されている
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クラウドベースまたはオンプレミスでの導入が可能
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システム構成および管理に関するITスキルは不要
セキュリティの向上とパフォーマンスの最適化
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クラウドベースまたはオンプレミス
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