Active Pharmaceutical Ingredient (API)
Active Pharmaceutical Ingredients (API) refers to an active ingredient that is contained in the medication. See Drug Stubstance.
Abridged Application
Abridged applications are applications where, subject to certain conditions, the applicant is not required to provide the results of pharmacological and toxicological tests or the results of clinical trials. An…
Abbreviated New Drug Application (ANDA)
An ANDA (ANDA) is an abbreviated version of an New Drug Application (NDA). It is allowed for duplicates of drug products that were first approved before October 10, 1962 and…
Adverse Drug Reaction (ADR)
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients. Adverse Drug Reaction: The detection, assessment, understanding and prevention of ADR are…
Signal Detection
Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies,…
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.
Dendreon Selects Ennov’s Unified Regulatory Suite
Dendreon selected Ennov Regulatory Suite to implement a cloud-based, unified electronic document management, publishing, and regulatory information management (RIM) software system to manage regulatory documents, publishing and product registrations, as…
5 Myths About eTMF
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In this blog article, I look…
Ennov to Sponsor TMF Summit
Ennov is pleased to announce that we are sponsoring the Trial Master File Summit being held at the Roosevelt Hotel in New Orleans, LA on May 2-4, 2022. This year’s…
Ennov Acquires MACRO from Elsevier to Reinforce its Leadership Position in the EDC Field
Ennov, the provider of the only unified compliance platform for Life Sciences – a highly configurable software architecture that provides a consistent user experience and eliminates data silos –, has…
Ennov Announces the Release of Version 9.3
Ennov, a leading provider of innovative software solutions for the Life Sciences industry is pleased to announce the release of Version 9.3 of its unified compliance platform. This release introduces…
Ennov to Sponsor the 2022 Global Pharmaceutical Regulatory Affairs Summit
Ennov is pleased to announce its sponsorship for the 2022 Global Pharmaceutical Regulatory Affairs Summit (GPRAS) being held in Berlin on April 6-8, 2022. In addition to the on-site event,…
Ennov’s Humanitarian Response to the Crisis in Ukraine
Ennov is deeply concerned about the situation in Ukraine and is closely following the humanitarian crisis unfolding there. Although we have no direct activity in Ukraine, we are very aware…
Ennov Opens New Office in the US
Ennov, a leading provider of innovative software solutions for the Life Sciences industries is pleased to announce the opening of a new office in Saint Joseph, Missouri. The new office…
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate regulatory information in one place,…
Ennov to Sponsor the AFCROs Clinical Research Day
Ennov is pleased to announce its participation and sponsorship at the 10th edition of the AFCROs (French Association of CROs) Clinical Research Day being held at the Hyatt Regency Etoile…
Ennov to Exhibit at the 2022 DIA RSIDM Forum
Ennov is pleased to announce that we will be exhibiting at the 2022 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum being held at the Bethesda North Marriott Hotel…
The Journey to Risk-Based Clinical Analytics
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches in almost all of their…
Case Study: IRE
This QMS project had two major objectives: ensure the safety of patients and staff, as well as foolproof reliability.
Ennov to Exhibit at the 6th European Conference on Clinical Research
Ennov is pleased to announce its participation in the 6th European Conference on Clinical Research. This hybrid conference will have a digital presence as well as an in-person event at…
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.
Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes from Version 2.1 of the…
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the latest news in the RIMS…
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the latest news in the RIMS…
Maintaining Compliance: Adapting to Changing Requirements
As the industry continues to move towards structured data, the compliance requirements of RIM systems will only increase.
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the latest news in the RIMS…
Ennov Opens New Office in Vietnam
Ennov, a leading provider of innovative software solutions for the Life Sciences industries is pleased to announce the opening of a new office in Hanoi, Vietnam. Together with the European…
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.
Ennov to Sponsor 10th TMF Summit
Ennov is pleased to announce that we are sponsoring the 10th annual Trial Master File Summit being held at the Roosevelt Hotel in New Orleans, LA on October 25-27, 2021.…
FDA eCTD-Related News
At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months. Our users appreciated the information – everyone tries…
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.
Ennov RIM platform implemented at Boehringer Ingelheim
Ennov’s strategic customer Boehringer Ingelheim selected the Ennov RIM as a global Regulatory Information Management (RIM) system for their Animal Health and Human Health businesses. The first major milestone was…
Ennov to Sponsor the Clinical Quality Oversight Forum
September 27-29, 2021 in Philadelphia, PA Ennov is pleased to announce that we are sponsoring the Clinical Quality Oversight Forum being held at the Hilton Philadelphia City Line Avenue Hotel…
Ennov Recognized by Gartner in the 2021 Hype Cycle for Life Sciences R&D
Ennov is Recognized in 5 Different Technology Areas Ennov today announced it has been recognized five times by Gartner as a vendor in the 2021 “Hype Cycle for Life Science…
Archiving a CRO-Generated eTMF: Considerations for Sponsors
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post provides recommendations for sponsors to…
Webinar : Manage larger and more numerous clinical studies with our dedicated software platform
30 minutes to learn how to improve the quality and timeliness of your studies requiring more patients and centers especially in the COVID context. Tuesday July 20 from 2:00pm (CEST)…
Gartner | Strategic Life Science Regulatory Information Management: From Fragmented to Holistic
As per Gartner, “Poor data quality, disjointed solutions and siloed regulatory business processes delay life science companies’ entry into new markets. This research illuminates the current state of regulatory technology,…
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.
Brexit Lingers on in the RIM World
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
Pharmacovigilance Signal Detection and Data Analysis
Learn how PV-Analyzer can help prepare statistical detailed analyses of safety data to reduce risk
Regulatory Webinar: Ennov Dashboards in Action: Visualize Your Regulatory Risk and Status
Tuesday, 20 April 2021 11:00AM EDT | 5:00PM CEST Encouraged by Health Authorities, many life sciences companies have adopted risk-based approaches throughout the organization. But effective risk management programs require…
Gartner market Guide for Life Science Regulatory Information Management Solutions
Ennov gives you complimentary access to : “Gartner Market Guide for Life Science Regulatory Information Management Solutions” As per Gartner,”Regulatory information management vendors offer new solutions to manage the increasingly…
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated change history and links to…
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period from 1 April 2018 to…
Gartner: Hype Cycle for Life Science Research and Development, 2020
Ennov gives you complimentary access to Gartner's report: "Hype Cycle for Life Science Research and Development, 2020*" This Gartner Hype Cycle is a reference for Life Science CEOs."Use this…
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was issued without comment, and includes…
RIM Webinar: Accelerate Time to Value by Leveraging Predefined Regulatory Processes
Tuesday February 16, 2021 - 11:00 AM EST | 5:00 PM CET Join our free webinar to learn the benefits of leveraging our library of predefined Regulatory processes that address…
Ennov CTMS Dashboards
Learn how Ennov Analytics Dashboards are used to manage risk, increase efficiency and improve insight.
Ennov Launches the Ennov Insider
Ennov is pleased to announce the launch of the Ennov Insider – a new, exclusive library of premium content available only to registered users. The Ennov Insider contains white papers,…
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
Pharmacosmos Adopts Ennov to Support Quality/GxP Operations
Ennov are pleased to announce that the Danish pharmaceutical company Pharmacosmos has implemented Ennov Doc and Ennov Training for the management of their global Quality and GxP documentation. Following the…
Ennov Announces the Expansion of the Regulatory Team
Ennov is pleased to announce the addition of Steve Clark to our team of Regulatory experts. Steve has over 20 years of global Regulatory operations experience that he gained at…
Smart Signal Management in Pharmacovigilance
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate, communicate and take action on…
Clinical CAPAs: Are Your Trials in a State of Control?
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to believe that a quality system…
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices, and solutions. One of the…
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018 and has been revised with…
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.
Ennov is Recognized in Gens & Associates 2020 World Class RIM Study
Ennov announces its inclusion in the “2020 World Class RIM Whitepaper; Is Industry at a Performance Tipping Point”, published by Gens & Associates, a leading independent consultancy specializing in strategic…
Ennov Recognized by Gartner in 2020 Market Guide for Quality Management System Software
Ennov announces its inclusion in the 2020 “Market Guide for Quality Management System Software”, published by Gartner, Inc., the leading information technology research and advisory company. According to Gartner, “The…
Synairgen Selects Ennov PV to Support COVID-19 Clinical Trial
Synairgen has selected Ennov PV to support the conduct of a clinical trial of SNG001 in patients with COVID-19. Synairgen will be using the Ennov PV Works solution to collect,…
Ennov Announces the Release of Version 8.6 with Full XEVMPD Support
Ennov, a leading provider of innovative software solutions for the Life Sciences industry is pleased to announce the release of Version 8.6 of our unified compliance platform. The release includes…
Webinar: Mastering The Challenges of RIM Data Migration
Join our free webinar to learn how fme Life Sciences and Ennov are working together to mitigate the data migration risks associated with Regulatory Information Management (RIM) implementations. We will…
FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA…
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of excellent information not previously available…
Ennov to present the latest version of its game-changing RIM at the 2020 Global Pharmaceutical Regulatory Affairs Summit, Berlin, April 21-23
Ennov is pleased to announce that we will be exhibiting at the 2020 Global Pharmaceutical Regulatory Affairs Summit (GPRAS) being held at the Berlin Hotel Palace on April 21-23, 2020.…
Ennov and fme Life Sciences Announce New Partnership
fme Life Sciences to offer enterprise content and data management services in support of Ennov’s Regulatory solution suite. Ennov and global professional services firm fme Life Sciences are pleased to…
Ennov to Exhibit at the 2020 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum
Ennov is pleased to announce that we will be exhibiting at the 2020 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum being held at the Bethesda North Marriott Hotel…
Optimize Your eTMF Strategy
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume 11, Issue 11). I wanted…
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will submit a single submission in…
Ennov to Sponsor 9th TMF Summit and CROWN Congress January 21-23, 2020 in Orlando, FL
Ennov is pleased to announce that we are sponsoring the 9th Trial Master File Summit and CROWN Congress being held at the Sheraton Lake Buena Vista Hotel in Orlando, FL…
RIM Webinar – Understand the Basics of RIM in 30 Minutes
Dec 10th at 11 AM – 11:30 AM PST | 2 PM – 2:30 PM EST With the increasing complexity of the global regulatory landscape, Regulatory Information Management (RIM) is…
Ennov Recognized by Garner in Multiple 2019 Research Reports
Ennov announces its inclusion in four 2019 Life Science market research reports published by Gartner, Inc. the leading information technology research and advisory company. The following reports recognize Ennov solutions:…
6 Considerations for Selecting an EDC Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the big, well-known EDC providers, to…
Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures
Most people think of Regulatory Information Management (RIM) as a set of tools and processes to manage product submissions and registrations, track regulatory commitments, and integrate regulatory correspondence. But for…
Ennov to Exhibit at the 2019 RAPS Regulatory Convergence being held 21-24 September 2019 at the Philadelphia Convention
Ennov is pleased to announce that we will be exhibiting at the 2019 RAPS Regulatory Convergence conference (booth 309) being held 21-24 September 2019 at the Philadelphia Convention Center in…
Risk-Based Monitoring Improved
On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations”. The sessions featured 24…
Ennov Named a Representative Vendor by Gartner in 2019 Market Guide for Life Science E-Clinical Platforms
Ennov announces its inclusion in the 2019 “Market Guide for Life Science E-Clinical Platforms”, published by Gartner, Inc., the leading information technology research and advisory company.According to Gartner, For life…
Ennov and Genpact Announce New Partnership
Genpact to offer Data Management Services in support of Ennov’s Regulatory Information Management Solution Ennov and global professional services firm Genpact (NYSE: G) are excited to announce a new partnership…
Ennov to Exhibit at the 2019 DIA Global Annual Meeting, June 23-27 in San Diego, CA
Ennov is pleased to announce we will be exhibiting at the DIA Annual Meeting being held June 23-27, 2019 at the San Diego Convention Center, San Diego, CA. The DIA…
Top 25 Pharmaceutical Company Selects Ennov for Global Regulatory Information Management
Ennov is pleased to announce the selection of Ennov RIM by one of Pharmaceutical Executive’s “Top 25 Companies” for the management of their global Regulatory information. Currently, the company utilizes…
Ennov is Recognized in Gens & Associates 2018 World Class RIM Study
Ennov announces its inclusion in the “2018 World Class Regulatory Information Management Whitepaper; Connections to Supply Release, Product Change and QMS”, published by Gens & Associates, a leading independent consultancy…