Ennov CTMS
Ennov CTMS facilitates the end-to-end management of clinical trials. The software allows sponsors to be more efficient, to make better decisions, to ensure compliance, to select investigators well, to monitor patient recruitment and to manage finances. Ennov CTMS includes comprehensive directories to manage site personnel (investigators, sub-investigators, study coordinators, pharmacists) and organizations (hospitals, competent authorities, CROs, suppliers).
Ennov CTMS provides functions for tracking patients, patient visits, EDC data, activities, queries, deviations, adverse events, drug supply, monitoring visits and finances. A full complement of reports and dashboards provide total visibility into the status of each study, country, site and investigator to provide the information necessary to make the best decisions possible.
- Comprehensive CTMS software
- Integrated with Ennov Clinical Data Management
- Clear visibility into investigational sites
- Integrated workflow
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Ennov Process
The Ennov platform includes its own workflow engine that provides advanced capabilities. Workflows are used in Ennov Training, Ennov eTMF and Ennov RIM. They allow control of the sequencing of tasks and data modification while providing visibility across the organization. Workflows are entirely configurable by functional administrators (through a graphical interface). Coherence checks are performed whenever you save modifications in order to make sure they do not cause inconsistencies. Thus, Ennov guarantees workflows are coherent and reliable. Each Ennov workflow is associated with a configurable form. Data entry is facilitated using dynamic sections that are displayed – or not – depending on previously entered field values (for example: the type of Incident). The connected user enters free text, selects values in picklists and adds additional files when needed. An electronic signature can also be required to complete a workflow step.
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Ennov Quality Suite
Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency
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Ennov Regulatory Suite
Ennov Regulatory Suite, a world-class regulatory content and information management is a unified, centralized, end-to-end solution that is robust enough to support the regulatory information workflow from the earliest stages of research and development through market authorization. It is a common principle shared by companies striving to achieve regulatory operational excellence. These companies understand that an such a solution will help them drive harmonization, promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product release and allow them to operate and compete more effectively in global markets. The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning.
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