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.
eCTD 4.0 & Medical Devices: What’s Happening in 2025?
Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory
eCTD 4.0 Pilot Readiness Checklist
eCTD 4.0 is one of the main focal points of the regulatory world, and participating in an eCTD 4.0 pilot is a great opportunity to get experience with the future of regulatory submissions. Make sure you’re prepared and get the most out of your pilot experience!
Effortless Data Enrichment for IDMP Compliance
Meeting the EMA’s IDMP requirements is critical, but it doesn’t have to be complicated. Ennov’s powerful automated solution simplifies PMS
Aligning RIM and PMS: Challenges for a Systematic Comparison
Discover essential strategies in this informative session with Ennov’s own Pierre Stanislawski and Maxime Delpire, as they dive into the
Global eCTD Regulatory Updates
The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.
Transforming Regulatory Affairs for a Biopharma Leader
One of the world’s largest and most respected biopharma companies selected Ennov for its world-class Regulatory Information Management (RIM) system.
Ennov RIM for Med Device
A dynamic, all-in-one regulatory information management solution crafted for medical devices, pharmaceuticals, and combination products. The platform ensures continuous compliance,
Future-Proofing Quality Management: A Guide for SMBs in Life Sciences
For small and mid-sized life sciences companies, maintaining quality standards amid constant industry evolution is an uphill battle. With limited
Compliance Without Compromise: Med Device Edition
Medical device companies must navigate the complexities of new regulations like the EU’s MDR/IVDR and the FDA’s UDI requirements. These mandates demand a higher
AI in Quality Management with ION Pharma
In this podcast, Ennov joins ION Pharma to discuss the complexities of modern quality management systems and how AI is
AI and Its Impact on Life Sciences
Discover how Generative AI is revolutionizing drug development, healthcare, and regulatory compliance, shaping the future of the industry.
AI-Driven Cosmetovigilance Solution for the Global Leader in Luxury
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Unified Quality and Regulatory Information Management
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
Case Study: Pharmacosmos
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
IDMP without Data Re-entry
Join us on a journey to discover the key strategies for streamlining IDMP compliance without the burden of data re-entry.
Navigate PV Safety with Confidence, Gain Instant Insights, and Take Action!
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IDMP: What’s Different This Time?
Tune in to gain insights from industry experts as they unpack the challenges and opportunities lying ahead for IDMP.
Navigating The Regulatory Landscape: The Ultimate Guide to Your IDMP Journey
Explore the intricate paths of regulatory compliance, with a focus on IDMP and SPOR, their implementation, and the urgency for proactive action.
Ennov’s Agnostic Solution for IDMP, the EASI connector
How are you going to be ready for IDMP compliance? Ennov has the answer.
PV Made Simple
Are you looking for a transformative solution to streamline your PV processes without compromising compliance?
Streamlining your eTMF: 10 Best Practices for Reducing Both Effort and Risk
Are you looking to maximize the efficiency of your electronic Trial Master File (eTMF) while minimizing effort and risk? Look
PV-Signal Manager
Manage safety signals and demonstrate a robust approach to signal detection with a searchable repository and workflow-driven solution.
PV-Works Vet
Ensure veterinary safety with a flexible & compliant pharmacovigilance (PV) software. Manage data easily, meet critical reporting deadlines.
PV-Works Human
Ensure patient safety with Ennov PV-Works, the comprehensive pharmacovigilance software that streamlines adverse event management, reporting.
PV-Analyzer
Efficiently detect potential signals with Ennov PV-Analyzer. A feature-rich, easy-to-use statistical analysis tool for pharmacovigilance.
Why SMBs should choose a right-sized RIM
Maximize your regulatory team’s potential with a right-sized RIM. Learn how SMBs can bring products to market faster with fewer resources.
Ennov Dossier
Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.
Ennov Doc
Efficiently manage and share documents with Ennov Doc. Metadata-based document model, efficient search capabilities, intuitive interface.
Ennov CTMS
Efficiently manage clinical trials with Ennov CTMS. Unified platform, pre-integrated with eTMF and EDC, customizable workflows.
Ennov Doc for Regulatory
Effortless Regulatory Submission Documentation. Preconfigured document inventory, intuitive interface, efficient search capabilities.
Ennov EDC
Simplify Clinical Data Collection with Ennov EDC. Configurable edit checks, allowable values library, and pre-integrated with eTMF and CTMS.
Best Practices: Master Data Management
Learn how master data management impacts regulatory affairs. Explore the importance of RIM and IDMP integration for data quality, compliance.
Ennov eTMF
Effortlessly manage clinical trial documentation with Ennov eTMF. Centralized repository, intelligent automation, and real-time dashboards.
Ennov Process
Streamline Your Business Processes with Ennov Process BPMS. Automate, ensure compliance and increase efficiency.
Ennov Training
Streamline Training with a Learning Management System. Simplify compliance monitoring, evaluate staff proficiency, automate onboarding.
Going Paperless: Best Practices for Creating Certified Copies
In this white paper, we explore the regulatory requirements, processes, and best practices related to creating certified copies of original documents within an eTMF system.
Case Study: Horiba
Horiba leverages a DMS to standardize workflows, eliminate paper, reduce time spent searching for information, and improve collaboration between departments.
Case Study: Maincare
Learn how Maincare is leveraging Ennov Doc and the Ennov REST API to include document management capabilities in their products.
Ennov RIM
Learn how Ennov RIM can help streamline regulatory processes and improve data quality.
Sponsor Oversight and the Role of eTMF
Sponsor oversight of TMFs is a critical regulatory requirement for clinical trials, but it can be challenging to know where
Benefits of Implementing an End-to-end RIM Platform
Why should you consider a Regulatory Platform instead of a standalone RIM solution? In less than 30 minutes, learn first steps, realistic objectives, and business benefits.
Case Study: PV Animal Health
Ennov assisted a valued Animal Health customer of almost 20 years in moving PV operations from a local installation to
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.
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.
Managing Clinical CAPAs
Learn why effective management of Clinical CAPAs is key to operating in a state of control.
Optimize Your TMF Strategy
Learn why an optimized TMF strategy is essential to maintaining inspection readiness and reducing risk.
Case Study: Vetoquinol
Learn how Vetoquinol implemented Ennov Doc and Ennov QMS to reduce compliance risk and improve performance.
Case Study: Septodont
Implementing an electronic document, business process and training management solution to increase efficiency across the organization.
Case Study: Pure Drug Safety
Utilizing Ennov PV to drive drug safety outsourcing services to pharmaceutical companies.
Case Study: Almedis
Leveraging Ennov Clinical to transform business by delivering Clinical data management services and increasing revenue.
Case Study: Laboratoire Aguettant
Aligning regulatory activities to strengthen competitive position.