Active Substance
The substance responsible for the activity of a medicine. See Drug Stubstance.
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…
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 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 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,…
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.
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…
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…
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.
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 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…
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…
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…
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…
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…
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.
Case Study: Septodont
Implementing an electronic document, business process and training management solution to increase efficiency across the organization.
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…
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 Recognized by Gartner 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 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…
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…
Boehringer Ingelheim selects the Ennov platform for Regulatory Information Management
Following a comprehensive review of the Regulatory Information Management marketplace, Boehringer Ingelheim have chosen the Ennov platform for their global RIM needs across both human and veterinary sectors. The Ennov…
Ennov Named a Representative Vendor by Gartner in 2018 Market Guide for Quality Management System Software
Ennov announces its inclusion in the 2018 “Market Guide for Quality Management System Software”, published by Gartner, Inc., the leading information technology research and advisory company. According to Gartner, “Organizations…
EudraVigilance Update, GVP Module IX, and the Impact on Signal Detection
With the release of the new Eudravigilance system on 22nd November 2017, the European Medicines Agency (EMA) have introduced greater access to adverse event data stored in the central repository.…
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