For more than 15 years, Ennov has been developing innovative, powerful and easy-to-use software for document and process management. Relying on more than 500 customers, Ennov has specialized its software for the health and life sciences sectors: Quality, Pharmacovigilance, Clinical studies and Regulatory affairs.
Unified Content Management ECM: Document management, workflows, and business intelligence
Ennov solutions are built on a unified content management platform adapted to the management of regulated content.
The Ennov platform is the technological basis of our regulatory applications (RIM, IDMP, MAA submissions, regulatory EDMS), quality (quality EDMS, quality BPM), eTMF and CTMS.
Ennov platform strongly differentiates the Ennov suite from other existing offers:
- Adapted to life sciences (complies with 21 CFR part 11)
- Open to integrations via its REST API
- Improvements of the platform benefits the business applications
- Easily configurable
- Generic-adaptable to customer needs
- Modern and perennial – at the forefront of technical developments
- Unified ergonomics, consistent throughout the software suite
Ennov QMS is a comprehensive and integrated solution that encompasses in one web application Document Management, Workflow Management and Training Management in the most intuitive package on the market.
Ennov Doc – Quality Documentation
The most intuitive electronic document management software on the market. Ennov Doc manages the entire document life cycle. Your business experts can configure the system without IT intervention:
- Integrated Dashboard: Users manage documents by priority
- Metadata-oriented browsing to quickly retrieve documents
- Powerful Search engine
- Openness to integrations thanks to the REST API
- Pre-configured for quality documentation
- Generic EDMS enables to manage any type of documents
Ennov DOC software
Ennov Process - Quality Processes
Workflow/BPM software designed for the user. Your business experts configure workflows without any IT intervention. Built-in reporting to drive your quality indicators and generate completely configurable reports.
- 100% Web interface to model any type of workflow
- Workflows and Forms Graphic editor
- Tools to track and control current workflow instances
- Powerful Search engine
- Set up reports and dashboards
- Real Time statistical analysis
Ennov Process software
Simplified training planning and follow-up: Guarantee the traceability of trainings and the probative value of training documents. Automate administrative work (revision of documents, staff movements, training module validity):
- Configurable training validation Workflows
- Native integration with Ennov EDMS and BPM
- Assessment Management
- Monitoring of document learning by trainees
- ISO 9001 and FDA 21 CFR Part 11 Compliance
- Training progress Indicators
- Flexible and simple setting
Ennov Training software
Integrated EDMS, RIM, IDMP and Submission Publishing to simplify your regulatory activities
Ennov Doc – Regulatory content
High-performance regulatory EDMS to prepare your submissions. Document management is a very large effort in MAA submissions. The strong integration between document management and MAA dossier publishing is essential to be more effective and avoid errors. Ennov’s EDMS is the most advanced regulatory document management software on the market. 100% Web, it saves you valuable time: simple search, metadata-oriented views and classification, comprehensive document lifecycle management. It is natively integrated with Ennov dossier, our MAA dossier publishing software.
Ennov DOC software
Ennov Dossier – MAA Dossier Submissions
100% Web MAA Dossier Publishing software, the most modern on the market. Native integration with Ennov Doc, Ennov RIM and Ennov IDMP. Ennov Dossier is comprehensive and very easy to implement. You manage and publish Your MAA dossier submissions in all the most important formats:
- eCTD and NeeS for electronic publications. Manage the drug life cycle in eCTD.
- vNeeS for the veterinary sector
- eCopy for medical devices
- Common Technical Document (CTD) for paper publications
Ennov Dossier software
Complete IDMP data Management Solution. IDMP data management implies considerable effort (working time and complexity of the process). With Ennov IDMP and related services, simplify the implementation and maintenance of your IDMP data.
- Simple IDMP Data Management
- Save time, avoid double data entries
- Increase data quality
- Natively integrated with Ennov Doc (EDMS), RIM, file (MAA submissions)
- IDMP Services: We help you to set up the IDMP standard, mandatory in Europe in 2018
Ennov IDMP software
Facilitate the registration of your medications in different countries and accelerate their marketing. With Ennov RIM, globally drive your MAA registrations and submissions:
- Authorizations managed by Product, indication, country
- Schedule submissions and renewals
- Identify market opportunities
- Compliance with the IDMP standard
- EDMS, MAA dossier submissions, RIM are all pre-integrated
- Configurable workflows
- Quick implementation for an outstanding ROI
Ennov RIM software
Ennov Clinical Suite: Quality of your data, rapid creation of your eCRF, traceability of your international trials.
Easily manage multi-center clinical study data with one comprehensive software. Easily collect data. Create your eCRF three times faster. Ennov EDC is CDISC certified for transactional ODM/XML data export: You can manage CDISC compliant archives. Our intuitive EDC software greatly simplifies:
- Consistency testing
- Medical Coding (MedDRA, WHO Drug)
- Data Import and export
- eCRF creation
- Offline mode (on IPAD)
Ennov Clinical EDC software
Monitoring of clinical trials and multi-study supervision. Natively integrated with Ennov EDC, Ennov CTMS is easy to integrate with EDCs from third-party publishers (Monitoring and data management information automatically recovered).
- Manage more complex studies with constant resources
- Optimize CRAs monitoring visits
- Follow patient recruitment
- Re-evaluate objectives and action plans
- Follow expenses and budget (mono and multi-studies)
- Comply with regulatory constraints (centralized information, effective processes)
- Start the studies, activate the research centers more quickly
- Identify trends between investigators, centers and studies to make the right decisions
Ennov CTMS software
Randomize on-line patients in your clinical trials. Our data management suite includes a complete IWRS. Comprehensive panel of features, very easy to set up.
- Settings can be done without programming
- Choice of methodology (blocks, stratification, minimization)
- Facilitates blindness, no anticipation of future allowances
- Unlimited number of layers and treatment arms
- Stratification (enumerated or continuous variables)
- Randomization Control (consistency testing, email alerts)
- Number of boxes calculated according to the weight of the patient...
Ennov Randomisation software
Have your patients enter electronic data without having to worry about access, forms recovery or security.
- Intuitive input for the patient
- Investigators access patient data in real time
- Easier data management compared to paper questionnaires
- Significant decrease in project costs
- Data entry through a WEB application
Ennov Clinical ePRO software
Clinical Trial Documents Management. Manage your eTMF. Visually follow your studies and follow-up documents for audits and submissions.
- 100% Web Access perfect for remote auditing
- Powerful Search engine
- Suitable for international use
- Comprehensive Integrated EDMS
- Preconfigured with the DIA eTMF model
- Compliant with FDA recommendations for clinical trial audits
- Easy Navigation and synthesis: configurable views, queries, statistics
Ennov eTMF software
Management of human or veterinary adverse events in a 100% accessible database. Signal detection.
Pharmacovigilance database. An industry standard, PV-Works is used by many pharmaceutical companies, CROs and consultants to record and report adverse events. It meets international regulatory requirements, including ICH E2B electronic submission.
- Deployed in the cloud or on-site
- Validated Solution
- Compliance is ensured
- Structured data collection – improves trend tracking and subsequent analysis
- Manages pharmaceutical biological and cospetic 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. Many statistics dedicated to pharmacovigilance. Powerful visualization and data sharing capabilities.
- Data Cube: Explore and manipulate data relationships
- Statistical Stratification
- Visual indicators of potential signals are customizable
- Graphic output for reports and presentations
- Experienced support team
Ennov PV Analyzer software
Effective entry of pharmacovigilance cases. A WEB application that revolutionizes the management of pharmacovigilance cases. Optimized Interface to meet the needs of users who receive reports, capture data, and manage case tracking.
- Configurable Interface to reflect the call flow, device type, and user experience level
- Modern and intuitive web design
- Accelerate data entry: drag-and-drop entry for regularly used data
- Speech recognition to reduce data entry
- Quick deployment, reduced training costs
Ennov PV-Entry software
Remote entry of pharmacovigilance data. Structured Format with standard vocabulary lists. Very Fast user training. Automatic translation during case import. Lightweight PDF file or dynamic browser-based Web form optimized for smartphones and tablets.
- 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