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…
Ennov User Meeting 2019
Ennov will be holding our annual US User Meeting April 8-10, 2019 at the Scottsdale Plaza Resort in Scottsdale, Arizona. This year’s meeting features four different tracks: Veterinary Pharmacovigilance, Human…
Ennov will be exhibiting at the 2019 Global Pharmaceutical Regulatory Affairs Summit
Ennov will be exhibiting at the 2019 Global Pharmaceutical Regulatory Affairs Summit, being held 8-10 April 2019 at the Crowne Plaza Fira Center, in Barcelona, Spain. Visit us on booth #16…
Ennov PV – An Auto-Testing Revolution
[Reading time 5 minutes] Acceptance testing has always been an important part of our lives at Ennov PV. Understandably, our customers have high expectations with respect to quality in the…
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 to Exhibit at the 2019 DIA RSIDM Forum
Join Ennov at DIA’s Regulatory Submissions, Information, and Document Management Forum. Stop by Booth #203 to learn more about our innovative software suite that spans the entire RSIDM continuum. Ennov’s…
Ennov to Exhibit at the 10th Annual SCOPE Summit for Clinical Ops Executives
Ennov will be exhibiting at the 2019 SCOPE Summit, being held 18-21 February 2019 at the Hyatt Regency Orlando in Orlando, Florida. Visit our Clinical team at Booth 514 to…
Ennov will be exhibiting at the DIA Pharmacovigilance and Risk Management Strategies Conference
Ennov will be exhibiting at the DIA Pharmacovigilance and Risk Management Strategies Conference, January 28-30, 2019 in Washington, DC. Stop by Booth 203 and speak with our experts about…
Ennov Exhibits at PCT-Europe 2018 Conference in Barcelona
Ennov will be exhibiting at the Partnerships in Clinical Trials (PCT) Europe Conference, from 27-29 November 2018, in Barcelona, Spain. Join us at Europe’s most complete clinical meeting for 3…
Ennov V8.3 announcement
Ennov is pleased to announce the release of version 8.3 of the Ennov Platform. Version 8.3 includes significant improvements to: Ennov 21CFR, which is now completely integrated into the main…
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…
Ennov and PQLOGIX Partner to Bring Quality Management Software to the Chinese Market
Ennov is pleased to announce a partnership with PQLOGIX, a leading business-to-business system integrator and software reseller located in Shanghai, China. PQLOGIX provides quality and process improvement software solutions and…
Ennov to Exhibit at 2018 RAPS Regulatory Convergence, October 1-4 in Vancouver, BC
Ennov is pleased to announce that we will be exhibiting at Regulatory Affairs Professionals Society (RAPS) 2018 Regulatory Convergence (booth 536) being held October 1-4, 2018 at the Vancouver Convention…
Ennov to Exhibit at SCDM Annual Conference September 23-26,2018, Seattle-Bellevue
Ennov is pleased to announce that we will be exhibiting at the Society for Clinical Data Management (SCDM) 2018 Annual Conference being held September 23-26, 2018 at the Hyatt Regency…
Ennov to Exhibit at the 2018 DIA Global Annual Meeting, June 25-27 in Boston, MA
Ennov is pleased to announce we will be exhibiting at the DIA Annual Meeting being held June 25-27, 2018 at the Boston Convention and Exposition Center, Boston, MA. The DIA…
Ennov USA User Group Announcement
Ennov will be holding our annual US User Meeting April 9-11th at the Hotel Royal Sonesta in New Orleans, LA. This year’s meeting features three different tracks: Veterinary Pharmacovigilance, Regulatory…
Ennov Annual USA User Meeting – New Orleans – April 9-12th 2018
Ennov will be holding our annual US User Meeting April 9-11th at the Hotel Royal Sonesta in New Orleans, LA. This year’s meeting features three different tracks: Veterinary Pharmacovigilance software,…
Ennov to Exhibit at the DIA RSIDM Forum February 5-7, 2018 in Bethesda, MD
Ennov is pleased to announce that we will be exhibiting at the DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum being held February 5-7, 2018 at the Bethesda North…
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.…
Ennov to Exhibit at the SCOPE Summit February 13-14, 2018 in Orlando, Florida
Ennov is pleased to announce we will be exhibiting at the 9th annual SCOPE Summit for Clinical Operations Executives, February 13-14, 2018, at the Hyatt Regency Orlando in Orlando, Florida.…
Ennov Announces AtEvent Acquisition
Paris, December 1st 2017 Ennov announces the acquisition of AtEvent, publisher of the Atrium™ software suite for professional event and scientific congress management. This acquisition strengthens Ennov’s leading position in…
Our Journey with Scrum
[Reading time 10-15 minutes] As we approach our first eighteen months of using the Agile Scrum methodology at Ennov PV, it seems a good time to reflect on our journey…
Top 5 eTMF Features | etmf systems
Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to ensure regulatory compliance of data…
Ennov Attends the SCDM 2017 Conference in Orlando, Florida
Last month Phillip Strickland and Mathieu Fourtillan from Ennov attended the Society of Clinical Data Management (SCDM) 2017 Conference in Orlando, Florida. The SCDM conference brings together hundreds of clinical…
Ennov to exhibit at Partnerships in Clinical Trials – Europe
Join Ennov as we exhibit at the Partnerships in Clinical Trials – Europe conference 28-29 November 2017 in Amsterdam. Stop by exhibit booth #51 to meet the Ennov team and…
Ennov’s Blog is Live
I am excited to announce that as of next week, on Monday, September 23rd, Ennov's blog is live. We will share with all of you our insights about how regulated…
Webinar: Introduction to Ennov Clinical (Nov 14, 11AM EST)
Please register for our Nov. 14th (11AM Est) webinar. Our free webinar will address how Ennov's clinical suite enables you to: Enter & manage clinical trial data with our easy to use…
TOPRA Regulatory Affairs Symposium, London, 2nd-4th Oct.
October 2nd to 4th, Park Plaza Victoria, London Are these issues familiar to you ? Scrambling to implement IDMP Increasing workloads to publish submissions in more countries and multiple formats…
The New Ennov 8 is Now Available!
We are pleased to inform of the release of version 8 of the Ennov Platform! Based on a modern EDMS and BPMS, the Ennov Platform enables you to manage Documents,…
Sept. 13th/27th Webinars: Ennov’s cloud Regulatory Submission Service – Discover eCTD247
Please register to our Sept. 13th (11am pst/2pm est) or Sept. 27th (11am pst/2pm est) webinar. Our free webinar will address how Ennov's eCTD247 cloud based Regulatory submission service enables…
Ennov Clinical EDC Version 8 Released and CDISC Certified
Ennov, a leading provider of regulated content management solutions for the Life Sciences industry, announces the release of version 8 of its Electronic Data Capture (EDC) solution, Ennov Clinical EDC.…
Fleming. 4th Annual Pharmacovigilance and Risk Management Strategies Forum, US
September, 27-28, - Key Bridge Marriott, Washington DC USA Ennov, a Life Science software vendor, exhibits its Ennov 8 platform and Pharmacovigilance Solutions at the Fleming. 4th Annual Pharmacovigilance and…
SCDM 2017 Annual Conference in Orlando, FL USA- September 24th to the 27th
September, 24-27, - Grande Lakes Orlando - SCDM 2017 Annual Conference, Orlando, Florida Ennov, a leading provider of regulated content management solutions for the Life Sciences industry, will exhibit its Clinical…
RAPS 2017 Regulatory Convergence National Harbor, MD USA
September, 9-12, - Gaylord National Resort and Convention Center - RAPS 2017 Regulatory Convergence, National Harbor, Maryland Ennov, a Regulatory software vendor, exhibits its new Ennov 8 Platform and its Regulatory…
DIA 2017 Annual Meeting in Chicago, US- June 18th to the 22nd
June, 18-22, - McCormick Place, Chicago, IL Ennov, a Life Science software vendor, exhibits its Ennov 8 platform and our four turnkey solutions at the DIA 2017 Annual Meeting at…
ASQ 2017 World Conference in Charlotte, US- May 1st to the 3rd
May, 1-3, - Charlotte Convention Center, Charlotte, NC Ennov, a Quality software vendor, exhibits its Quality Management Software at the ASQ 2017 World Conference at the Charlotte Convention Center (Stand 318),…
ISPE 2017 Europe Annual Conference in Barcelona, Spain- April 3rd to the 5th
April, 3-5, - the Crowne Plaza Barcelona, Barcelona, Spain Ennov, a Regulatory and Quality software vendor, exhibits its Regulatory Software Suite and Quality Management Software at the ISPE 2017 Europe Annual Conference at…
DIA Euromeeting Glasgow, Scotland- March 29th to the 31st
March, 29-31, - Scottish Exhibition & Conference Centre - SECC, Glasgow, Scotland Ennov, a Regulatory software vendor, exhibits its Regulatory Software Suite at the DIA Euromeeting at the Scottish Exhibition & Conference…
DIA Forum Bethesda, MD- February 6th to the 8th
February, 6-8, - Mariott Hotel and Conference Center, Bethesda, MD, USA Ennov, a Regulatory software vendor, exhibits its Regulatory Software Suite at the DIA Forum at the Mariott Hotel and Conference Center…
DIA Conference Washington DC – 23rd to 25th January
January, 23-25, - Mandarin Oriental Washington DC, USA Ennov, a Pharmacovigilance software vendor, exhibits its Pharmacovigilance Software Suite at the DIA Conference at the Mandarin Oriental Hotel (Booth 27), set to begin on…
Submit your PSUR in eCTD format with eCTD247
Since June 2016, an EMA guideline states that marketing authorisation holders must submit E.U. Periodic Safety Update Reports (PSUR): In eCTD or NeeS format To the central PSUR repository, using EMA's eSubmission Gateway…
Dec. 15th Webinar: Quality Management Solution for Low Cost SOP, Deviation, CAPA Best Practices
Please register to our Nov 17 (2:00 PM EST) webinar. Our free webinar will show how to use Ennov's new V7 Quality EDMS to: Implement quality best practices Achieve lost…
Implement GMPs with an Integrated QMS: GAMP 5 Quality conference, Mannheim
November, 15-17, - Mannheim Dorint Kongresshotel, Germany Discover Ennov's Quality Management Offer at this year’s annual GAMP 5 2016 Conference, Booth 2 (15th & 16th of November) & 14 (17th of…
Reduce Costs with Integrated Quality Management for Pharma: RQA2016 Booth18
November, 9-11, - Brighton Hilton Metropole, UK Ennov, a Quality software vendor, exhibits its QMS Management Offer at this year’s annual RQA Conference (Booth 18) at the Brighton Metropole Hotel, set to begin…
Nov. 16th Webinar: Ennov’s PV247 cloud pharmacovigilance system
Please register to our Nov. 16th (10am east) webinar. Our free webinar will address how Ennov's www.PV247.com cloud based pharmacovigilance service enables you to: manage a human or a veterinary…
Nov. 3rd Webinar: Discover eCTD 247 – cloud-based Regulatory submission service
Please register to our Nov 3 (2:00 PM EST) webinar. Ennov's webcast will walk you through the benefits of eCTD 247: Prepare, manage and submit your IND, NDA, ANDA or…
Webinar: Quality Management Solution for Low Cost SOP, Deviation, CAPA Best Practices
Please register to our Nov 17 (2:00 PM EST) webinar. Our free webinar will show how to use Ennov's new V7 Quality EDMS to: Implement quality best practices Achieve lost…
Ennov recognized by Gartner as a RIM and IDMP vendor
Ennov among few RIM / IDMP vendors Paris, France & Greensboro, USA – September 20th 2016 Ennov announces that it has been listed by Gartner's Michael Shanler as a RIM…
Ennov recognized by Gartner in the Hype Cycles for Life Sciences
Ennov a Recognized Vendor in 4 Different Technology Areas Ennov today announced it has been listed four times by Gartner as a vendor in the 2016 “Hype Cycle for Life…
Webinar: Streamline Quality Management with a Modern QMS
Please register to our Sep 15 (2:00 PM EDT) webinar. Our free webinar will help you answer: How to determine if your company is ready to make the change from…
Join Ennov at RAPS Regulatory Convergence 2016 – Booth 401
September, 17-20, - The San Jose Convention Center, CA, USA Ennov, a regulatory affairs software vendor, exhibits its RIM software at this year’s annual RAPS Conference (Booth 401) at the…
Ennov launches its new RIM software solution on the DIA 2016 Conference: join us and learn how to best manage your regulatory documents and processes
June 26-30, 2016 – Philadelphia, PA DIA 2016 Conference | Booth 1255 Ennov is pleased to be an exhibitor again at the DIA 2016 Conference. Come to our booth to…
Discover our exclusive new cloud-based service: eCTD247
Launched on October, 24 Prepare, manage and submit your IND, NDA, ANDA or BLA submissions, regardless your level of eCTD expertise. With the eCTD 247 package, simple eCTD submissions can…
Join us at RAPS Regulatory Convergence 2015 | Booth 312
October, 24-28, - The Baltimore Convention Center, MD, USA - Booth #312 Ennov, an industry expert in regulatory affairs management software solutions, today announces its exhibiting at this year’s annual…
Join us at DIA 2015 51st Annual Meeting| Booth 1145
DIA 2015 51st Annual Meeting June 14-18 – Walter E. Washington Convention Center, Washington DC, USA| Booth 1145 We're proud to be exhibiting at the DIA 2015 51st Annual Meeting…
Join us at DIA eRegulatory and Intelligence | Booth 100
DIA eRegulatory and Intelligence Conference 2015 May, 11-13 – Sheraton Philadelphia, PA, USA - Booth #100 This year DIA EDM and ERS is combining with DIA RIM for the eRegulatory…
Visit us at ASQ 2015 on May 4-6 | Booth 334
World Conference on Quality Improvement- ASQ 2015 May, 4-6 2015 – Nashville, TN, USA Ennov Solutions is pleased to take part of the 2015 World Conference on Quality Improvement.Join over…
Ennov Pharmacovigilance|User Meeting
Save the date for the upcoming Ennov PV-Works (Vet) User Meeting March 23-24, 2015 – Richmond, VA Ennov is pleased to announce that the Assured (now part of Ennov Group)-…
Ennov at 2015 PDA Annual Meeting- Parenteral Drug Association
PDA Annual Meeting Explores the Future of Manufacturing March 16-18, 2015 – Las Vegas, NV Today, more than ever, quality has become a fundamental pillar to every organizations. The 2015…
PV-Works is Ennov’s new Pharmacovigilance Solution.
With Assured Solutions Systems acquisition by Ennov Group in July 2014, PV-Works pharmacovigilance software leader has become the Ennov pharmacovigilance solution. Merge of activities has been accelerating Ennov’s international expansion, specifically…
Ennov at DIA eCTD+ RIM Conference 2015
DIA - DIA eCTD+ RIM Conference 2015 eRegulatory and Intelligence Annual Conference May 11-13, 2015 – Philadelphia, PE Ennov Solutions is pleased to take part in the DIA eCTD+ RIM…
Ennov at ASQ 2015 – World Conference on Quality & Improvement
Transforming the World Through Innovation, Inspiration, and Leadership May 4-6, 2015 – Nashville, TN With globalization, the influence of quality reaches beyond individual organizations, industries, countries, or regions. More and…
Meet us at DIA – Euro Meeting 2015
DIA - Euro Meeting 2015 April, 14-15 2015 – Paris, France Ennov Solutions is pleased to take part in the DIA EuroMeeting 2015. The conference will debate about the issues…
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