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.
Ennov Sponsors the 2023 RAPS Euro Convergence
Ennov will be sponsoring and exhibiting at the RAPS Euro Convergence 2023 conference from May 10-12, 2023 at the Park Inn by Radisson Amsterdam City West in Amsterdam, The Netherlands. …
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,…
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.
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…
Enhancing Technology Strategy for Efficient Clinical Development
As clinical trial complexity increases, life sciences companies must have a technology strategy that supports research, development, and commercial business units. A recent Gartner report, "Navigate a Path to Digital…
Case Study: Horiba
Horiba leverages a DMS to standardize workflows, eliminate paper, reduce time spent searching for information, and improve collaboration between departments.
Integrated Software: Revolutionizing Customer Complaints and CAPA Management
The pharmaceutical industry plays a critical role in ensuring the health and well-being of people all over the world. With this important responsibility, it is essential for Life Science companies…
Case Study: Maincare
Learn how Maincare is leveraging Ennov Doc and the Ennov REST API to include document management capabilities in their products.
Why SMBs should choose a right-sized RIM | Regulatory Webinar
Regulatory Webinar Why SMBs should choose a right-sized RIM Are you in late phase development or have you just received approval for your product?See how a RIM system can maximize…
Maximizing Value in Healthcare: How CIOs Can Drive Ongoing Strategic Cost Optimization
Healthcare and Life Science CIOs are facing mounting pressures to manage costs, optimize resources, and deliver value in an environment characterized by competing priorities and internal politics. A recent report…
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 to start. In this on-demand webinar, interviews from a panel…
Finding the Right Fit: Key Considerations for Selecting an Integrated Quality Management System
As a Life Sciences professional, finding the right vendor for your integrated document management, learning management, and quality management systems (QMS) is a critical decision. With so many options available,…
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…
Ennov to Sponsor TMF Summit
Ennov is pleased to announce that we are sponsoring the Trial Master File Summit being held in West Palm Beach, FL on March 20-22, 2023. The event welcomes Life science professionals from…
Ennov to Exhibit at the 2023 DIA RSIDM Forum
Ennov is pleased to announce that we will be exhibiting at the 2023 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum being held at the Bethesda North Marriott Hotel and Conference…
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.
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 assisted a valued Animal Health customer of almost 20 years in moving PV operations from a local installation to a new SaaS cloud environment. The result: An extremely smooth…
Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. A wide variety of stakeholders are involved, from manufacturing/supply change to corporate quality to regulatory affairs…
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
Developmental International Birth Date (DIBD)
Date of approval of the first authorization for conducting an interventional clinical trial in any country. Determines the start of regulatory requirement. The first data lock point for the DSUR…
Important Risk
Definition according to GVP Annex I (Rev 3): An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for…
Potential Risk
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this…
Identified Risk
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest. Explanatory wording provided in GVP…
Temporal Relationship
Temporal relationship is considered positive if the event occurred during the use of the drug and/or within a plausible range based on the half-life of the drug. Categories for temporal…
Seriousness vs. Severity
The term ‘severe’ must not be confused with ‘serious’. In the English language, ‘severe’ is used to describe the intensity (severity) of a specific event (mild, moderate or severe); the…
Abuse
Persistent or sporadic, intentional excessive use of medicinal product, which is accompanied by harmful physical or psychological effects.
Suspected Unexpected Serious Adverse Reaction (SUSAR)
A SUSAR is a serious ADR whose nature or severity is unexpected based on the applicable product information.
Unexpected Adverse Reaction
An adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information. Any event that is not expected, in accordance with the label (USPI…
Side Effect
Unintended effect occurring at normal dose related to the pharmacological properties.
WHO DD (WHO Drug Dictionary)
An international classification of drugs providing the names and active ingredient of medicinal products used in different countries.
WHOART (WHO Adverse Reactions Terminology)
Dictionary meant for rational coding of adverse reaction terms, maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring.
United States Prescribing Information (USPI)
It sets out the agreed usage of the drug in the USA and provides information for healthcare professionals on the drug’s usage, efficiency and safety. This is part if the…
Unexpected Adverse Drug Reaction
An adverse reaction whose nature, severity, specificity, or outcome is not consistent with the description given in product labelling or market authorization (USPI in the US, SmPC in Europe).
Type (A to F) of Adverse Drug Reaction
A (augmented): common dose-related reaction, related to a pharmacological action of the drug, predictable and with low mortality.B (bizarre): uncommon non-dose-related reaction, not related to a pharmacological action of the…
Spontaneous Reporting
Reporting of AE cases by health professionals and pharmaceutical companies which does not derive from a study or any organized data collection scheme (i.e. is not solicited). Stimulated reporting Reporting…
Solicited Reports
Reports derived from organized data collection systems, including: Clinical trialsClinical registriesPost-approval patient use programsPatient support programsPatient disease management programsSurveys of patients or healthcare providersInformation on efficacy or patient compliance
Signal Validation
Evaluation of the data supporting a detected signal to verify that there is sufficient evidence demonstrating a new potentially causal association, or a new aspect of a known association.
Signal Management Process
A set of activities performed to determine whether there are signals associated with medicinal product (based on ICSRs, data from active surveillance systems or studies, literature information, etc.) including: Signal…
Signal
Reported information on a new possible causal relationship (or a new aspect of a known relationship) between an adverse event and a drug. A signal is considered important and warrants…
Safety Specification
This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of: The important identified risksImportant potential risksMissing information It should also address:…
Safety Concern
An important identified risk, important potential risk or important missing information. Medicinal product safety concerns are identified, characterized, and monitored in the DSUR, RMP and PSUR.
Safety
Evidence of an absence of harm (not absence of evidence of harm). Judgement about safety takes into account the degree to which a given risk is acceptable.
International Serious Adverse Events Consortium (SAEC)
Non-profit consortium formed between the US FDA, industry, academia and the Wellcome Trust to identify genetic variants associated with SAEs.
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
results in deathrequires patient hospitalizationresults in persistent or significant disability or incapacityis life-threateningor is a congenital anomaly/birth defect.“Severe” describes the intensity of an event (mild, moderate or severe), the event…
Risk Minimization Activity
Product informationHealthcare professional communications / educational materialsPatient communications / educational materials
Risk Management Plan (RMP)
MAHs must prepare an RMP (Risk Management Plan) to implement the risk management system.
Risk Management
Activity that aims to ensure that the benefits of a medicinal product exceed the risks by the greatest achievable margin, by increasing the benefits or reducing the risks in three…
Risk
The probability of developing an outcome (refers normally but not always to a negative outcome). Absolute risk or Incidence Rate: The observed or calculated probability of the occurrence of an event in a…
Reference Risk (or Baseline Risk)
Risk in a population of unexposed persons. It can be measured over time (incidence) or at a given time (prevalence).
Rational Drug Use
Therapeutic practice where drugs are prescribed and used appropriately for the indication and the patient’s specific characteristics.
Prevalence
The proportion of total cases in a population at a particular time and a descriptive statistic, rather than a measurement of risk.
Prescription Event Monitoring (PEM)
System created to monitor adverse drug events for identified patients receiving a specified drug (prescribers are requested to report all events, suspected adverse or not).
Predisposing Factors
Aspects of the patient’s history which might explain reported adverse events (genetic, other drugs, disease history…).
Postmarketing Surveillance
The study of drug use and effects after release into the market.
Pharmacovigilance System
A system used by an organization to comply with pharmacovigilance regulations and designed to monitor the safety of authorized medicinal products.
Pharmacovigilance Master File
A compilation of information, maintained by the MAH. containing a detailed description of the pharmacovigilance system they use, available to competent authorities upon request.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, in order to: Prevent harm from ADRs in humans arising…
Pharmacoepidemiology
The study of the use and effects of drugs in large numbers of people using an epidemiological approach
Post-Authorization Safety Study (PASS)
Study relating to an authorized medicinal product conducted with the aim of studying a safety hazard, confirming the safety profile of the product, or evaluating risk management measures.
Overdose
Administration of a quantity of a medicinal product above the maximum recommended dose allowed by the authorized product information.
Off-Label Use or Misuse
Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the marketing authorization. For instance, medicine used: For disease that it is not approved…
Odds and Odds Ratio
An Odds is the probability of an occurrence divided by the probability of its non-occurrence. The Odds ratio is the ratio of the Odds between two populations.
Number Needed to Harm (NNH)
Number of individuals needed to be treated for some specified period in order that one person would have one harmful event.
Near-Misses
Medication errors with high potential for causing harm but did not (cancelled before reaching a patient or reaching the patient but who did not have untoward consequences).
National Pharmacovigilance Centers or National Competent Authority (NCA)
Regulatory authority within a country with the clinical and scientific expertise to collect, analyze and advise on drug safety.
Missing Information
Potentially clinically significant gap in knowledge about the safety of a medicinal product for a specific patient population or concerning certain anticipated utilization (for instance long term use). Typical examples…
Minimum Criteria for Reporting
An identifiable reporter, patient, event and a suspect medicinal product are required for reporting cases of suspected adverse events.