Introducing Ennov 10.3
We are thrilled to announce the release of Ennov 10.3, delivering even greater satisfaction to our platform's users. This latest version introduces two significant new features: Enhanced AI Capabilities Ennov…
Product Management Service (PMS)
The Product Management Service (PMS) is a core element of the European Medicines Agency's (EMA) IDMP implementation. PMS provides a centralized, standardized database for managing medicinal product information across the…
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards IDMP implementation yet with the…
Global eCTD Regulatory Updates
The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.
Ennov and CognifAI Partner for AI-Driven Pharmacovigilance
Ennov, a leading provider of unified compliance software solutions for the Life Sciences, is pleased to announce a strategic partnership with CognifAI, an innovative AI solutions company specializing in pharmacovigilance.…
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European Medicines Agency (EMA) stand out…
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication and collaboration we ensure that…
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK's departure from the European Union has…
Transforming Regulatory Affairs for a Biopharma Leader
One of the world’s largest biopharmaceutical companies needed a more consistent way to manage regulatory information and content across its global animal health portfolio. Disconnected processes made it harder for…
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies - all with limited resources…
Ennov Completes the Enterprise Technology Integration from Calyx
Ennov is proud to announce the successful integration of the Enterprise Technology division from Calyx into our organization. This strategic acquisition, completed on June 1, 2024, significantly enhances Ennov’s portfolio…
Ennov Artwork
Ennov Artwork offers a powerful set of tools focused on content management, allowing content to be itemized, annotated, proofed, and compared down to the pixel. Changes between versions can be…
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 agility, and reducing the risk of non-compliance in the fast-evolving…
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 resources and leaner teams, these businesses grapple with unique obstacles…
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s recent report, “Peer Lessons Learned…
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s Quality Management System Regulation (QMSR)…
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments received to date can be…
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of 2022 and its 2023 amendment.…
Artificial Intelligence (AI)
A branch of computer science dedicated to creating systems capable of performing tasks that typically require human intelligence. These tasks include learning, decision-making, problem-solving, and pattern recognition.
Why Unified Platforms are the Future of Cosmetovigilance
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU Cosmetics Regulation 1223/2009 has brought…
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 since 1987, has partnered with Ennov to enhance consumer safety…
Dermatological Safety Assurance with Unified Platforms
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer trust. Companies bear the critical…
Ennov Announces Strategic Acquisition of Calyx’s ‘Enterprise Technology’ Division
In a landmark move for the life sciences industry, Ennov has acquired the 'Enterprise Technology' division from Calyx. This acquisition significantly expands Ennov's portfolio by integrating the advanced eClinical and…
Ennov Boosts Portfolio with Acquisition of DocShifter: The Market-Leading Document Transformation Solution
In a move that signifies a major advancement in the life sciences industry, Ennov, a leader in regulated content management solutions, has acquired DocShifter, a top provider of document automation…
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The New Wave of QMS [8/8]: Reflections & Looking Ahead
The horizon for Quality Management Systems (QMS) is brimming with opportunities, ready to revolutionize the Life Sciences field. As we conclude our blog series on the future of QMS, let's…
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The New Wave of QMS [7/8]: Cybersecurity Measures
In today's digitally-driven era, data plays a paramount role in shaping the trajectory of the Life Sciences industry. As organizations increasingly rely on digital tools and platforms for quality management,…
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The New Wave of QMS [6/8]: Flexibility & Adaptability
The Life Sciences sector, by its very nature, is in a state of continual evolution. Innovations in research, shifts in market dynamics, and alterations in regulatory landscapes mean that static…
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The New Wave of QMS [5/8]: User-Centric Interface
The global nature of the Life Sciences industry brings with it an inherent diversity—geographically spread teams, a variety of roles, and a broad range of technical expertise levels. Amidst this…
The Trust Equation: Safety, Branding, and Consumer Loyalty
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate complexity during innovation and expansion.…
Holistic Beauty and Safety Compliance: Bridging the Gap
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations in expanding markets. This balance…
Sustainability in Safety: The Cosmetovigilance Approach
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global regulations. Managing safety data sustainably,…
Streamlining Operations with Digital Cosmetovigilance
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while meeting global safety regulations. Scaling…
Case Study: Pharmacosmos
Learn how Pharmacosmos implemented Ennov Doc and Ennov QMS to become paperless and unify the organization
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that signifies not just adherence to…
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The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
In the Life Sciences industry, Quality Management Systems (QMS) serve as the cornerstone for ensuring product integrity, compliance with stringent regulations, and ultimately, patient safety. The landscape of QMS has…
Regulatory Compliance in the Cosmetics Industry
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs cosmetics under the Federal Food,…
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.
Ennov Forms Strategic Partnership with ION Pharma to Elevate Quality Management in Life Sciences
Ennov is pleased to announce a strategic partnership with ION Pharma. This alliance marks the beginning of a collaborative effort that merges over two decades of expertise in electronic Quality…
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.
Navigating IDMP Compliance: The Time is Now
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41% of organizations are already actively…
Gartner Insights: IDMP & EMA Compliance
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and authoritative approach. The challenge lies…
Best Practices: Cross-Referencing in eCTD
Today, the eCTD format remains the only globally approved and ICH-recommended standard. While it has been in use for more than 15 years, it is the mandated submission format for…
Mastering Master Device Data: MDM Benefits for Compliance, Safety, Agility
For medical device companies, accurate and consistent data is critical for regulatory compliance and patient safety. Master Data Management (MDM) is an essential process that enables medical device companies to…
Ennov’s Agnostic Solution for IDMP, the EASI connector
Webinar Introducing Ennov's Agnostic Solution for IDMP, the EASI connector How are you going to be ready for IDMP compliance? Ennov has the answer.June 21st at 11:00 AM – 11:30…
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.
Censored/Censoring of Data
An observation is said to be censored in time when the event of interest cannot be observed at the time at which the analysis isconducted. Special cases are right censoring…
Causality assessment
The evaluation of the likelihood that a medicine was the causative agent of an observed adverse event in a specific individual. Causality assessment is usually made according to established algorithms.…
Case report form (CRF)
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.Source: ICH Guideline E6: Good Clinical…
Caregiver
A person who helps a patient with daily activities, healthcare, or other activities that the patient is unable to perform because of age, illness or disability, and who understands the…
Candidate gene study
A study that evaluates the association of specific genetic variants with outcomes or traits of interest, selecting the variants to be tested according to explicit considerations (known or postulated biology…
Ennov Acquires RIM Solution Provider Samarind
Samarind Strengthens Ennov’s global position in the RIM for Medical Devices and its presence in the UK market Ennov, a leading provider of regulated content and data management software for…
Empower Your Quality Management Journey with Gartner Market Guide Insights
The Quality Management System (QMS) landscape is continually transforming, driven by innovative technologies and emerging trends. Discover the essential insights from Gartner's latest Market Guide for Quality Management System Software…
Ennov Dossier
Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.
Ennov Regulatory Documents
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 Regulatory Documents
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.
Burden to patients
The additional load that a clinical activity imposes on patients above that which would be experienced under normal clinical practice. Source: (CIOMS XI: Patient involvement 2022)
Burden of a risk minimisation activity
Burden is defined as the additional load that a risk minimisation activity imposes on (1) patients, (2) carers, (3) the healthcare system including health care professionals, (4) others such as…
Boxed warning (“black box warning”)
A warning that appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks. Not all health authorities implement boxed warnings in the label,…
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.
Bonferroni Correction
A correction to allow for the probability of many events that are independent, named after Carlo Emilio Bonferroni (1892-1960). In statistical significance testing, it allows, for example, 10 different significance…
Biomarker
A measured characteristic of either normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers.…
Binary Analysis
An analysis involving only two categories (e.g., baseline vs final values, in contrast to analysis of multiple values from continuous measurements, as for a progression of laboratory values). The latter…
Bayesian confidence propagation neural network (BCPNN)
Bayesian confidence propagation neural network (BCPNN) Empirical Bayesian algorithm used for signal detection in spontaneous report databases.Source: (CIOMS VIII: Signal detection 2010)
Bayesian
A theorem in probability named after Reverend Thomas Bayes (1702-1761). It is used to refer to a philosophy of statistics that treats probability statements as having degrees of belief, in…
Baseline characteristics
Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be initially similar between groups; if…
Analysis of covariance (ANCOVA)
A statistical method for making comparisons between groups, whiletaking into account different variables measured at the start of atrial. It is a form of multiple regression. Source: (CIOMS VI: Clinical…
Alert
An identified risk associated with the use of medicinal products which requires urgent measures to protect patients. Source: (CIOMS VIII: Signal detection 2010)
AGREE Instrument
A tool that assesses the methodological rigour and transparency in which a guideline is developed. Source: (CIOMS XI: Patient involvement 2022)
Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for paper documents and streamlining processes,…
Common Reasons for eCTD Rejection by the FDA and How to Prevent Them
Navigating the complex world of electronic Common Technical Document (eCTD) submissions to the FDA can be a daunting task. Ensuring compliance with FDA regulations and avoiding potential pitfalls is crucial…
Ennov’s Secret to Consistent Quality
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of maintaining a high level of…
Adoption
One of 5 dimensions in the RE-AIM evaluation model (Reach, Efficacy, Adoption, Implementation, Maintenance). Adoption refers to the participation rate and representativeness of both the settings in which an intervention…
Additional Risk Minimisation Measure
A risk minimisation measure which is in addition to the routine risk minimisation activities which apply to all medicinal products in a particular region or territory. Synonyms: Additional risk minimisation…
Active Surveillance System
A system for the collection of case safety information as a continuous pre-organized process. Active surveillance can be: Drug based: identifying adverse events in patients taking certain products; Identifying adverse…
Acceptable Risk
The degree of risk (likelihood of an adverse event or outcome) that a person or group is prepared to take or considers reasonable. However, what may be acceptable for one…
Academia
The environment or community concerned with research, education, and scholarship. Source: (CIOMS XI: Patient involvement 2022)
Absolute Risk
The number of people in a group who experience an adverse effect divided by the number in that group who could experience that adverse effect. Source: (CIOMS VI: Clinical trial…
Ennov Drives 30% Growth in 2022, Confirms Market Relevance
Ennov's regulatory and quality offers have registered excellent results, positioning the company as one of the world's leaders. The orders should enable another year of profitable growth. Ennov has greatly…
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.
Streamlining your eTMF: 10 Best Practices for Reducing Both Effort and Risk | Webinar
Maximize your eTMF efficiency, minimize your effort and risk: Attend our webinar to learn how! Wednesday, March 29th, 2023, 2pm EDT
Unlock The Full Potential of Product Development with EDMS
Webinar Unlock The Full Potential of Product Development with EDMS Streamline processes and break down silos to reduce time to market! Tuesday, March 7th, 2023, 2pm EST Save my seat…
Unlocking the Future of Healthcare: Insights from the 2023 Gartner Report on Digital Transformation
The life sciences industry is at the brink of a digital transformation, with economic pressures and disruptive technology and innovation challenging traditional business models. A recent Gartner® report entitled Predicts…
How Mobile EDC is Transforming Clinical Trials in 2023
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC applications, which can be run…
Case Study: PV Animal Health
Ennov supported a long-standing Animal Health customer of nearly 20 years in transitioning their PV operations from a local installation to a modern SaaS cloud environment. By leveraging advanced pharmacovigilance…
Ennov Announces the Release of Version 9.4
Ennov, a provider of innovative software solutions for the life sciences industry, is pleased to announce the release of version 9.4 of its unified compliance platform. The latest version includes…
Risk Management System (RMS)
A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions.
Regulatory Authority
The legal authority that is responsible for regulating all matters relating to drugs and medicinal products (e.g.: EMA, FDA, MHRA)
Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
Pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase.
International Birth Date (IBD)
The date of the first marketing authorisation for any product containing the active substance granted to any company in any country in the world.
Development Safety Update Report (DSUR)
Comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed