Welcome to Ennov Insider
Take advantage of the knowledge and best practices gained from more than 25 years of research, innovation and development for the health and life sciences sectors.
How to Move from TMF Workarounds to True Compliance
Are you still using spreadsheets, shared drives, or Word documents to manage your Trial Master File? Struggling to maintain compliance,
Beyond Silos: Unifying Quality & Regulatory
Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and
Case Study: Vetoquinol
Discover how Ennov’s unified ecosystem eliminated vendor sprawl, standardized processes, and enabled internal teams to own their expansion, all while maintaining zero disruption to business operations.
From Siloes to Synergy: Aligning Quality & Regulatory Ops
Learn how unified platforms eliminate traditional system boundaries to accelerate compliance, reduce costs, and create competitive advantage.
EMA IDMP Roadmap: PMS Data Alignment (Session 2 of 2)
As the EMA continues to refine its IDMP implementation approach — including adjustments to PMS migration rules — organizations must
Ennov IDMP EASI Connector for RIM Integration
Meeting the EMA’s IDMP requirements is critical, but it doesn’t have to be complicated. Ennov’s powerful automated solution simplifies PMS
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.
EMA IDMP Roadmap: Updates, Requirements and Impact on Industry (Session 1 of 2)
By the end of 2024, EMA released updated IDMP guidance and the PMS implementation guide, following key milestones including the
AI Reality Check & The IDMP Countdown
Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and
AI Vendor Checklist
Generative AI and LLMs are rapidly becoming essential in life sciences. To maximize impact, companies must critically assess use cases and choose vendors whose tools integrate seamlessly with their teams.
IDMP Starter Pack
The EMA is moving to a phased implementation, requiring MAHs to iteratively enrich data in the Product Management Service. With each stage demanding more information, early preparation is key. Without it, manual processes may become unsustainable. All MAHs face upcoming deadlines—act now to ensure your data, tools, and teams are ready.
Artwork Management Made Easy (with practical examples)
This 30-minute webinar covers improving Artwork management through standardized, compliant processes. Learn how to better organize and control your Artwork
How to Save Time Managing Agency Correspondence with AI
The increased volume of health authority interactions in the review and approval cycle has created a commensurate challenge for life sciences companies: increased workload and accelerated timelines to
Effective Training management powered by AI
Proving training records to regulatory authorities? Our AI-powered solution automatically generates compliance assessments from your documentation—no more manual effort, just
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!
Ennov Training
Streamline Training with a Learning Management System. Simplify compliance monitoring, evaluate staff proficiency, automate onboarding.
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 Artwork
Ennov Artwork offers a powerful set of tools focused on content management, allowing content to be itemized, annotated, proofed, and
Ennov RIM for Med Device
A tailored, agile, and comprehensive regulatory information management solution designed specifically for medical devices, enabling seamless global compliance, enhancing operational
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
AI-Driven Cosmetovigilance Solution for the Global Leader in Luxury
In a pioneering collaboration, the leading entity in the luxury cosmetics industry, known for its commitment to innovation and quality
Case Study: Pharmacosmos
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
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.
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.
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.
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
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.
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.
MHRA TMF Inspection Finding Checklist
Review tactics for preventing common eTMF Inspection Findings
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: 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.
