Discover essential strategies in this informative session with Ennov’s own Pierre Stanislawski and Maxime Delpire, as they dive into the challenges of aligning RIM and
The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.
One of the world’s largest and most respected biopharma companies selected Ennov for its world-class Regulatory Information Management (RIM) system. This leader in animal health
A dynamic, all-in-one regulatory information management solution crafted for medical devices, pharmaceuticals, and combination products. The platform ensures continuous compliance, supports operational agility, and minimizes
For small and mid-sized life sciences companies, maintaining quality standards amid constant industry evolution is an uphill battle. With limited resources and leaner teams, these
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 degree of traceability, transparency, and
In this podcast, Ennov joins ION Pharma to discuss the complexities of modern quality management systems and how AI is becoming an indispensable ally in
Discover how Generative AI is revolutionizing drug development, healthcare, and regulatory compliance, shaping the future of the industry.
In a pioneering collaboration, the leading entity in the luxury cosmetics industry, known for its commitment to innovation and quality since 1987, has partnered with
Learn how to achieving Regulatory Operational Excellence through unified Quality and Regulatory information management..
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
Join us on a journey to discover the key strategies for streamlining IDMP compliance without the burden of data re-entry.
Access this PV Safety Webinar on-demand to discover a comprehensive portfolio of PV Dashboards, and learn the methodology to design your own. Answering Key Questions
Tune in to gain insights from industry experts as they unpack the challenges and opportunities lying ahead for IDMP.
Explore the intricate paths of regulatory compliance, with a focus on IDMP and SPOR, their implementation, and the urgency for proactive action.
How are you going to be ready for IDMP compliance? Ennov has the answer.
Are you looking for a transformative solution to streamline your PV processes without compromising compliance?
Are you looking to maximize the efficiency of your electronic Trial Master File (eTMF) while minimizing effort and risk? Look no further! Our webinar is
Manage safety signals and demonstrate a robust approach to signal detection with a searchable repository and workflow-driven solution.
Ensure veterinary safety with a flexible & compliant pharmacovigilance (PV) software. Manage data easily, meet critical reporting deadlines.
Ensure patient safety with Ennov PV-Works, the comprehensive pharmacovigilance software that streamlines adverse event management, reporting.
Efficiently detect potential signals with Ennov PV-Analyzer. A feature-rich, easy-to-use statistical analysis tool for pharmacovigilance.
Maximize your regulatory team’s potential with a right-sized RIM. Learn how SMBs can bring products to market faster with fewer resources.
Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.
Efficiently manage and share documents with Ennov Doc. Metadata-based document model, efficient search capabilities, intuitive interface.
Efficiently manage clinical trials with Ennov CTMS. Unified platform, pre-integrated with eTMF and EDC, customizable workflows.
Effortless Regulatory Submission Documentation. Preconfigured document inventory, intuitive interface, efficient search capabilities.
Simplify Clinical Data Collection with Ennov EDC. Configurable edit checks, allowable values library, and pre-integrated with eTMF and CTMS.
Learn how master data management impacts regulatory affairs. Explore the importance of RIM and IDMP integration for data quality, compliance.
Effortlessly manage clinical trial documentation with Ennov eTMF. Centralized repository, intelligent automation, and real-time dashboards.
Streamline Your Business Processes with Ennov Process BPMS. Automate, ensure compliance and increase efficiency.
Streamline Training with a Learning Management System. Simplify compliance monitoring, evaluate staff proficiency, automate onboarding.
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.
Horiba leverages a DMS to standardize workflows, eliminate paper, reduce time spent searching for information, and improve collaboration between departments.
Learn how Maincare is leveraging Ennov Doc and the Ennov REST API to include document management capabilities in their products.
Learn how Ennov RIM can help streamline regulatory processes and improve data quality.
Sponsor oversight of TMFs is a critical regulatory requirement for clinical trials, but it can be challenging to know where to start. In this on-demand
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.
Ennov assisted a valued Animal Health customer of almost 20 years in moving PV operations from a local installation to a new SaaS cloud environment.
Explore concretes examples of divergence between a RIM data model and HA guidance data format.
Learn about enterprise-level data architecture using master level data management.
Discover the best practices for RIM Data modeling in the context of IDMP.
Episode 6 of our mini-series explores TMF Sponsor Access for Risk Management & Regulatory Compliance.
Episode 5 of our mini-series explores TMF Inspections for Risk Management & Regulatory Compliance.
Episode 4 of our mini-series explores TMF Quality for Risk Management & Regulatory Compliance.
Implementation of the Ennov solution resulted in a responsive call center platform to support global patient interactions.
Episode 3 of our mini-series explores TMF Timeliness for Risk Management & Regulatory Compliance.
Episode 2 of our mini-series explores TMF Completeness for Risk Management & Regulatory Compliance.
Episode 1 of our mini-series explores TMF Guide Review for Risk Management & Regulatory Compliance.
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.
This QMS project had two major objectives: ensure the safety of patients and staff, as well as foolproof reliability.
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.
As the industry continues to move towards structured data, the compliance requirements of RIM systems will only increase.
Risk-based clinical quality may require information from: the CTMS and eTMF, but also from the EDC, ePRO, RTS, RIMS, and QMS.
Ennov’s Partnership with Pharma IT provides a full pharma-focused solution that responds with a single repository platform.
Bachem Americas Inc. needed to identify a partner with a flexible
solution that could meet their specific needs for a RIM solution.
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.
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.
Learn how to decrease the time required to implement Regulatory Information Management systems using a streamlined approach.
Learn how PV-Analyzer can help prepare statistical detailed analyses of safety data to reduce risk
Review tactics for preventing common eTMF Inspection Findings
Learn how Ennov Analytics Dashboards are used to manage risk, increase efficiency and improve insight.
Learn how Ennov RIM and Documentum can operate effectively together in an enterprise system architecture.
Learn how Ennov RIM and Ennov PV are used to enable the efficient production of Periodic Safety Update Reports
Learn how Ennov RIM enables the effective management of CMC variation change controls.
Learn best practices for migrating documents from legacy systems into Ennov.
Learn how Ennov CTMS and eTMF enables planning, management, documenting of clinical trials.
Learn how Ennov RIM enables the management and submission of XEVMPD information to the EMA.
Learn how Ennov enables compliance with the US FDA’s 21 CFR Part 11 guidance.
Learn about the interactions between eDMS and IDMP to gain insights into the best practices regarding data governance and IDMP compliance.
Learn how Ennov Doc’s integration with Office 365 drives innovation through collaborative authoring.
Learn the key areas where a unified CTMS and eTMF can result in the greatest benefit.
Learn why effective management of Clinical CAPAs is key to operating in a state of control.
Learn why an optimized TMF strategy is essential to maintaining inspection readiness and reducing risk.
Learn how Vetoquinol implemented Ennov Doc and Ennov QMS to reduce compliance risk and improve performance.
Implementing an electronic document, business process and training management solution to increase efficiency across the organization.
Utilizing Ennov PV to drive drug safety outsourcing services to pharmaceutical companies.
Leveraging Ennov Clinical to transform business by delivering Clinical data management services and increasing revenue.
Aligning regulatory activities to strengthen competitive position.
© 2024 Ennov All rights reserved
