Welcome to Ennov Insider
Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.
Leveraging RIM for DADI and IDMP | Ep 3: Examples of Divergence
Explore concretes examples of divergence between a RIM data model and HA guidance data format.
Leveraging RIM for DADI and IDMP | Ep 2: Enterprise-Level Data Architecture
Learn about enterprise-level data architecture using master level data management.
Leveraging RIM for DADI and IDMP | Ep 1: Best Practices for Data Modeling
Discover the best practices for RIM Data modeling in the context of IDMP.
eTMF for Risk Management and Regulatory Compliance | Ep. 6: Sponsor Access
Episode 6 of our mini-series explores TMF Sponsor Access for Risk Management & Regulatory Compliance.
eTMF for Risk Management and Regulatory Compliance | Ep. 5: TMF Inspections
Episode 5 of our mini-series explores TMF Inspections for Risk Management & Regulatory Compliance.
eTMF for Risk Management and Regulatory Compliance | Ep. 4: TMF Quality
Episode 4 of our mini-series explores TMF Quality for Risk Management & Regulatory Compliance.
Ennov Serves as Global Patient Call Center Platform
Implementation of the Ennov solution resulted in a responsive call center platform to support global patient interactions.
eTMF for Risk Management and Regulatory Compliance | Ep. 3: TMF Timeliness
Episode 3 of our mini-series explores TMF Timeliness for Risk Management & Regulatory Compliance.
eTMF for Risk Management and Regulatory Compliance | Ep. 2: TMF Completeness
Episode 2 of our mini-series explores TMF Completeness for Risk Management & Regulatory Compliance.
eTMF for Risk Management and Regulatory Compliance | Ep. 1: Guidance Review
Episode 1 of our mini-series explores TMF Guide Review for Risk Management & Regulatory Compliance.
IDMP Considerations in 2022: Interoperable Structured Data Reporting
Interoperable structured data is increasingly burdensome for pharmaceutical companies. This white paper examines some real examples of interoperable structured data and provides some recommendations to prepare for future changes.
Case Study: IRE
This QMS project had two major objectives: ensure the safety of patients and staff, as well as foolproof reliability.
Completeness, Quality and Timeliness: A Deep Dive
This paper will examine the KPIs of Completeness, Quality and Timeliness in more detail in order to assist organizations in improving the quality and understanding of these metrics and their roles in risk management, continuous process improvement, and compliance.
Maintaining Compliance: Adapting to Changing Requirements
As the industry continues to move towards structured data, the compliance requirements of RIM systems will only increase.
White Paper: Clinical Analytics: The Journey from Problem Identification to Solution
Risk-based clinical quality may require information from: the CTMS and eTMF, but also from the EDC, ePRO, RTS, RIMS, and QMS.
Case Study: Pharma IT
Ennov’s Partnership with Pharma IT provides a full pharma-focused solution that responds with a single repository platform.
Case Study: Bachem
Bachem Americas Inc. needed to identify a partner with a flexible
solution that could meet their specific needs for a RIM solution.
Visualize Your Clinical Risk and Status with Ennov Analytics
This webinar showcases one of our newest products – Ennov Analytics, our powerful yet easy-to-use reporting and data visualization software. This presentation focuses on its use in conjunction with Ennov CTMS, our highly capable Clinical Trial Management solution.
Visualize Your Regulatory Risk and Status with Ennov Analytics
Learn how Ennov Analytics frees you from data gathering and spreadsheet manipulation by providing targeted dashboards where you can complete a precise analysis with just a few clicks.
Accelerate Time to Value by Leveraging Predefined Regulatory Processes
Learn how to decrease the time required to implement Regulatory Information Management systems using a streamlined approach.
Case Study: Pharmacosmos
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
Pharmacovigilance Signal Detection and Data Analysis
Learn how PV-Analyzer can help prepare statistical detailed analyses of safety data to reduce risk
MHRA TMF Inspection Finding Checklist
Review tactics for preventing common eTMF Inspection Findings
Ennov CTMS Dashboards
Learn how Ennov Analytics Dashboards are used to manage risk, increase efficiency and improve insight.
Integrating Documentum and Ennov RIM
Learn how Ennov RIM and Documentum can operate effectively together in an enterprise system architecture.
Unified PV and RIM
Learn how Ennov RIM and Ennov PV are used to enable the efficient production of Periodic Safety Update Reports
Unified QMS and RIM
Learn how Ennov RIM enables the effective management of CMC variation change controls.
Migrating Legacy Documents to Ennov
Learn best practices for migrating documents from legacy systems into Ennov.
Product Demo: Unified CTMS and eTMF
Learn how Ennov CTMS and eTMF enables planning, management, documenting of clinical trials.
Unified RIM and xEVMPD
Learn how Ennov RIM enables the management and submission of XEVMPD information to the EMA.
Ennov and 21 CFR Part 11
Learn how Ennov enables compliance with the US FDA’s 21 CFR Part 11 guidance.
eDMS and IDMP
Learn about the interactions between eDMS and IDMP to gain insights into the best practices regarding data governance and IDMP compliance.
eDMS and Office 365 Integration
Learn how Ennov Doc’s integration with Office 365 drives innovation through collaborative authoring.
White Paper: Unified CTMS and eTMF
Learn the key areas where a unified CTMS and eTMF can result in the greatest benefit.
Unified Quality and Regulatory Information Management
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
Ennov Report
Learn how Ennov Report can be used to drive better decision making through advanced data visualization.
Ennov Training
Learn how Ennov training automates the training of staff on corporate policies and procedures to keep training records up-to-date.
Ennov Process
Learn how Ennov Process can automate business processes to streamline business operations, ensure compliance and increase efficiency.
PV-Signal Manager
Learn how PV-Signal Manager can help with the prioritization, evaluation, classification and review of safety signals.
PV-Analyzer
Learn how PV-Analyzer can help prepare statistical detailed analyses of safety data to reduce risk.
PV-Works Vet
Learn how PV-Works Vet can help with the collection, management, reporting and evaluation veterinary safety data.
PV-Works Human
Learn how PV-Works Human can help with the collection, management, reporting and evaluation patient safety data.
Ennov EDC
Learn how Ennov EDC facilitates complete and accurate data collection and improves communication within clinical teams.
Ennov eTMF
Learn how Ennov eTMF provides all the functionality required to effectively and efficiently manage your clinical trial documentation.
Ennov CTMS
Learn how Ennov CTMS can help with the planning, management and reporting of clinical trials.
Ennov RIM
Learn how Ennov RIM can help streamline regulatory processes and improve data quality.
Ennov Dossier
Learn how Ennov Dossier helps meet Regulatory submission publishing challenges.
Ennov Doc for Regulatory
Learn how Ennov Doc can help meet Regulatory document management challenges.
Managing Clinical CAPAs
Learn why effective management of Clinical CAPAs is key to operating in a state of control.