For more than 19 years, Ennov has been developing innovative, powerful and easy-to-use software for document and process management. Using the knowledge and best practices gained from more than 500 customers, Ennov has designed and built solutions specifically for the health and life sciences sectors: Quality, Pharmacovigilance, Clinical Operations and Regulatory Affairs.
Unified Content Management: Document Management, Business Process Management and Business Intelligence
Ennov solutions are built on our Unified Content Management platform which is designed specifically for the management of regulated content and processes. The Ennov platform is the technological foundation of our Regulatory (EDMS, Dossier Publishing, RIM, IDMP), Quality (EDMS, QMS) and Clinical (eTMF and CTMS) solutions.
Our platform approach provides significant advantages over other products on the market:
- Meets the regulatory needs of life sciences organizations
- Complies with 21 CFR part 11
- Is open to integration with other systems via its REST API
- Is flexible and easy to configure
- Incorporates unified ergonomics that are consistent throughout the software suite
- Presents modern user experience and at the forefront technical innovation
Ennov QMS is a fully integrated software product suite that combines Document Management, Business Process Management and Training Management to form a complete end-to-end GxP compliance solution.
Ennov Doc – Quality Documentation
The most intuitive electronic document management software on the market, Ennov Doc manages the entire controlled document life cycle and provides your business experts with the flexibility to configure the system to meet their specific needs.
- Integrated Dashboard allows users to work on the highest priority documents
- Metadata-oriented navigation allows users to organize documents for easy location and retrieval
- Flexible security model provides or restricts access by user, group or role
- Powerful search engine supports metadata and full text queries
- REST API provides seamless integration with other Quality systems
- Pre-configured quality document inventory gets you up and running quickly
Ennov DOC software
Ennov Process - Quality Processes
Business Process Management and workflow software designed with the end user in mind. A graphical editor allows your business experts to configure workflows without any IT intervention. A built-in reporting tool is completely configurable and provides the analytics required to drive your quality metrics.
- 100% web interface to manage any type of business process and related forms
- Easy to use graphical workflow and forms editor
- Tools to track and control current workflow instances
- Powerful search engine
- Flexible reports and dashboards
- Real-time statistical analysis
Ennov Process software
A fully integrated Learning Management System simplifies the planning, execution and management of your training program and ensures compliance with your quality standards. Build training curriculums, monitor compliance and access staff proficiency without a heavy administrative burden.
- Configurable training validation workflows
- Native integration with Ennov EDMS and BPM
- Competency assessment management
- Monitoring and tracking of staff learning
- Training progress indicators
- ISO 9001 and FDA 21 CFR Part 11 compliance
Ennov Training software
Ennov Regulatory is an integrated EDMS, RIM, IDMP and Dossier Publishing product suite designed to streamline your Regulatory operations.
Ennov Doc – Regulatory content
A collaborative platform for the efficient creation and management of submission content – connecting your global regulatory community and accelerating your time to market. The pre-configured document inventory supports the DIA EDM reference model and provides the flexibility to adapt to the nuances of your regulatory operations.
- An integrated Dashboard allows users to work on the highest priority documents
- Metadata-oriented navigation allows users to organize, locate and retrieve documents with ease
- A flexible security model provides or restricts access by user, group or role
- A powerful search engine supports metadata and full text queries
- Robust and flexible workflows connect users across geographies and improve efficiency
- Pre-configured Regulatory document inventory gets you up and running quickly
Ennov DOC software
Ennov Dossier – Submission Publishing
Comprehensive and scalable submission publishing capabilities suitable for operations of all sizes. Produce output that is compliant with all current regulatory agency requirements. Ennov Dossier supports the creation of both electronic (eCTD, NeeS, VNeeS and eCopy) and paper submissions using one common interface.
- A 100% web-base, zero-footprint user interface makes it the ideal solution for multi-site or global deployments
- Easy-to-use submission assembly controls are designed specifically for the capture and management of eCTD metadata
- Submission assembly templates are provided for the regions that accept eCTD submissions
- Iterative publishing of individual sections of the assembly is supported
- Drag and drop documents from Ennov Doc or any WebDAV compatible repository into the submission assembly
- Includes robust hyperlinking, bookmarking and eCTD validation functionality
Ennov Dossier software
A complete IDMP solution. ISO IDMP data management can require substantial effort – considering the working time required and the process complexity. Ennov IDMP and related services, simplifies the creation and maintenance of your IDMP data and allows you to direct valuable regulatory resources to your most important projects.
- Simplified IDMP data management
- Saves time and eliminates redundant data entry
- Increases data quality and integrity
- Seamless integration with Ennov Doc and Ennov RIM
- Robust reporting and data tracking
- IDMP Services: We help you navigate the complexities of ISO IDMP and effectively implement the standard
Ennov IDMP software
A purpose-built application for the management and tracking of medicinal product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides users with the key information and functionality to effectively manage product registration portfolios worldwide.
- Authorizations managed by product, indication and country
- Plan, track and manage submission projects globally
- Compliance with the ISO IDMP data standards
- Seamless integration and interoperability with Ennov Doc and Ennov Dossier
- Configurable workflows and email notifications simplify regulatory task management
- Fast implementation timelines provide an outstanding ROI
Ennov RIM software
Ennov Clinical Suite: An integrated platform to manage all of your eClinical information and processes.
Easily manage single or multi-center clinical study data with one comprehensive solution. Create your eCRFs three times faster. Ennov EDC is CDISC certified for transactional ODM/XML data export allowing you to manage CDISC compliant archives. Our intuitive EDC software greatly simplifies:
- Consistency checking
- Medical coding (MedDRA, WHO Drug)
- Data import and export
- eCRF creation
- Offline data collection (on iPad)
Ennov Clinical EDC software
Provides clinical trial monitoring and cross-study controls. Ennov CTMS is natively integrated with Ennov EDC but can also be used with EDC solutions from third-party vendors (monitoring and data management information automatically retrieved).
- Manage more complex studies with fewer resources
- Optimize CRA monitoring visits
- Monitor patient recruitment
- Re-evaluate objectives and action plans
- Follow expenses and budget (single study and cross-study)
- Comply with regulatory constraints (centralized information, effective processes)
- Start the study and activate the research centers more quickly
- Identify trends between investigators, centers and studies to make the right decisions
Ennov CTMS software
Sophisticated and efficient randomization of your clinical trials. Our data management suite includes a complete IWRS with a comprehensive array of features that is very easy to set up.
- Settings can be made without programming
- Choice of randomization methodology techniques (blocks, stratification, minimization)
- Facilitates blinding, no anticipation of future allowances
- Unlimited number of layers and treatment arms
- Stratification (enumerated or continuous variables)
- Randomization control (consistency testing, email alerts)
- Trial supply management
Ennov Randomisation software
Accelerate study timelines and eliminate redundant clinical data entry. With Ennov ePRO, your patients can enter electronic data without having to worry about access, forms recovery or security.
- Intuitive data input for the patient
- Investigators have access to patient data in real time
- Simplified data management compared to paper questionnaires
- Significant decrease in project costs
- Data entry through a web-based application
Ennov Clinical ePRO software
Collect and manage essential clinical trial documents electronically in a central location and make them available to trial personnel from any location at any time. Streamline processes, increase transparency, simplify tracking and improve access using Ennov eTMF.
- 100% web-based solution is perfect for global trials
- A powerful search engine makes locating documents easy
- Workflow driven processes minimize operational variability
- The integrated EDMS platform is comprehensive and is preconfigured per the DIA eTMF reference model
- Compliant with FDA recommendations for clinical trial audits
- Easy navigation and synthesis using configurable views, queries, and visualization tools
Ennov eTMF software
An integrated safety suite for human or veterinary adverse event management and signal detection.
An industry standard, PV-Works is used by many pharmaceutical, animal health. medical device and clinical research companies to record, track and report adverse events. It meets all international regulatory requirements, including ICH E2B electronic submission.
- Deployed in the cloud or on-premises
- 21 CFR Part 11 compliant
- Straightforward case review and approval
- Coding of cases against current MedDRA dictionary
- Handles spontaneous and clinical trial adverse events, technical inquiries and product complaints
- Manages pharmaceutical, biological and cosmetic products as well as medical devices
Logiciel PV Works (humain)PV Works (Vet) software
Detection and analysis of pharmacovigilance signals. The implementation of a process to identify potential signals is essential. PV-Analyzer is a comprehensive signal detection and data mining software solution that includes robust data visualization and export capabilities.
- Robust data mining capabilities
- Comprehensive statistical stratification
- Advanced graphical data presentation and reporting
- High degree of configurability
- Available as cloud-based or on premises deployment
Ennov PV Analyzer software
Effective entry of pharmacovigilance cases. A web-based application that revolutionizes the management of PV data includes an optimized interface to meet the needs of users who manage PV cases.
- Configurable interface to reflect the call flow, device type, and user experience level
- Modern and intuitive web design
- Accelerated data entry: drag-and-drop entry for regularly used data
- Speech recognition to reduce data entry
- Fast deployment and reduced training costs
Ennov PV-Entry software
Remote entry of pharmacovigilance data. A structured data input format with standard vocabulary lists is available in a variety of languages including English, most European languages, Kanji, Arabic and Mandarin. Lightweight PDF forms or dynamic browser-based web forms are optimized for deployment on smartphones and tablets and securely upload data to the PV database.
- Data entry in the user's language
- Custom Interface: Input form configured to reflect the type of case or user experience level
- Smartphone/tablet-based deployment to access all features of the device
- Quick deployment: Capture data from new sources
Ennov PV-Express software