News and Events

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, Workflows, and Data in a unified way. The Ennov platform is the technological base for Ennov’s Regulatory and Quality applications, as well as Ennov’s eTMF and CTMS. Our platform based applications such as QMS, RIM and submission publishing, are also natively integrated.

All these applications benefit from the platform updates including the modern and intuitive interface, Office 365 and Google Drive integration, and easy metadata navigation.

The Ennov platform is perfectly suited for Life Science (21 CFR part 11 compliant), and open to integrations through its REST API.

Learn more about Ennov 8 and its new features.

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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 you to:

  • Prepare, manage and submit your IND, NDA, ANDA or BLA submissions, regardless of your level of eCTD expertise
  • Publish simple eCTD submissions by yourself
  • Use our submission services for more complex submissions
  • Save time, money and resources using eCTD intelligence embedded into the software itself in a simplified intuitive manner

Register to our:

After registering, you will receive a confirmation email containing information about joining the webinar.

eCTD247

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. With over 15 years of experience, Ennov Clinical EDC version 8 contains an improved and modern user interface, harmonizing the EDC application with all other Ennov products, as well as other new features and functionality.

The new EDC user interface includes a new study homepage, system navigator toolbar, and a new dashboard with widgets. In addition, the new responsive design will allow the EDC application to be accessed across all web browsers, on any type of computer or tablet. “The responsive design contained in Ennov Clinical EDC version 8 will give our users the flexibility to work on whatever type of system they are accustomed to, whether that be a desktop, laptop or tablet such as an iPad, and have the same user experience,” said Mathieu Fourtillan, Director of Ennov Clinical. “This also includes an updated EDC Mobile app for iPad that gives users the flexibility to work online or offline through the native app we have developed.” Ennov’s EDC Mobile app is available from Apple’s App Store.

Other Ennov EDC system features and functionality released with version 8 include:

  • eCRF Display Mode: the ability to design eCRFs with or without background pictures
  • Direct saving of each data value entered – auto save item by item
  • History – clickable links of visited pages
  • Advanced customization of patient IDs
  • Frozen study access – read-only access to frozen studies

“We are excited about the release of Ennov Clinical EDC version 8 and giving our EDC users a harmonized experience as they also use other Ennov solutions such as our Pharmacovigilance system, eTMF solution or our regulated content management platform” said Olivier Pâris, Chief Executive Officer of Ennov. “The other functionalities introduced in this version are a direct result of comments made by our customers in our annual user group meetings and we are pleased to be responsive to their continued needs.”

CDISC Certified

Ennov, announced today that its Electronic Data Capture (EDC) solution, Ennov Clinical EDC, has recently received the Operational Data Model (ODM) certification by the Clinical Data Interchange Standards Consortium (CDISC). This CDISC ODM certification ensures that Ennov Clinical EDC is capable of producing ODM files with a high level of conformity to the published specifications.

Ennov Clinical EDC version 8.0 was certified on the most recent ODM version, 1.3.2. “We are very pleased that Ennov EDC has been certified by the CDISC organization. This shows our customers that Ennov is dedicated to meeting their needs and ensuring our EDC solution is capable of adhering to industry data standards,” said Olivier Pâris, Chief Executive Officer of Ennov. “There are not many EDC systems in the market today that have received this CDISC certification, and even fewer that are certified on the current ODM version.”

Ennov Clinical EDC can support clinical studies of any size, including very large and complex global trials. Data management teams can easily design, deploy and manage multi-center clinical study data with one comprehensive solution with no programming or advanced IT skills required. Working together with Ennov’s ePRO, Randomization, and Medical Coding modules, Ennov Clinical EDC can support all end-to-end needs of capturing data for clinical research. “The rigorous process of this certification proves that Ennov Clinical EDC is fully compatible with the industry standards of data exchange and provides yet another tool to help our clients run efficient and effective clinical research programs”, stated Mathieu Fourtillan, Director of Ennov Clinical.

About CDISC

CDISC is a global, nonprofit organization that develops and supports global, platform-independent data standards to enable interoperability between information systems that improves medical research and healthcare. These data standards help streamline processes, improve data quality, facilitate data sharing and help reduce overall cost associated with clinical research and healthcare.

About Ennov

With over 15 years experience and 150+ Life Sciences clients worldwide, Ennov has the industry’s most integrated, cost-effective and user-friendly Life Sciences platform. Our 4 connected solutions; Quality, Regulatory, Clinical, and Pharmacovigilance, integrate with your workflow to help reach compliance and productivity goals faster, with no IT skills required. Headquartered in Paris, France, Ennov also has offices in Cambridge, UK, as well as Greensboro, North Carolina and San Francisco, California in the US. Head to our homepage to learn more about our comprehensive Life Sciences platforms.

September, 27-28, – Key Bridge Marriott, Washington DC USA

Fleming 4th Annual PV Strat

Ennov, a Life Science software vendor, exhibits its Ennov 8 platform and Pharmacovigilance Solutions at the Fleming. 4th Annual Pharmacovigilance and Risk Management Strategies Forum at the Key Bridge Marriott, set to begin September 27th.

We will present our newly updated Ennov Platform, as well as our Pharmacovigilance Software Suite. Ennov’s cloud-based and mobile software, which includes our Quality Management, Regulatory Pharmacovigilance, and Clinical Software Suites, integrates with your business workflow to help you reach your compliance and productivity goals faster, with no IT resources required.

Learn more about our four turnkey solutions to manage Life Science companies’ documentation and processes.

Fleming.’s 4th Pharmacovigilance and Risk Management Strategies (RMS) Forum offers a broad picture of drug safety priorities across the product lifecycle and looks into closing the long-existing loop in premarketing and post-marketing reporting. There you can explore the newest ways in facilitating modern pharmacovigilance and patient safety in Washington D.C. This event is set up in an interactive discussion format with attendance of 100+ senior industry practitioners & advisors representing large and most progressive pharmaceutical companies, biotech firms and regulatory bodies. The layout sets up debates on real life practices over 2 intensive days.

Based on several years of experience with this event, they guarantee to provide you the most up-to-date insight sharing and problem solving opportunities.

September, 24-27, – Grande Lakes Orlando – SCDM 2017 Annual Conference, Orlando, Florida

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Ennov, a leading provider of regulated content management solutions for the Life Sciences industry, will exhibit its Clinical Software Suite at the Society for Clinical Data Management 2017 Annual Conference. The SCDM conference will be held at the Grande Lakes-Orlando in Orlando, Florida, set to begin September 24th. Attending from Ennov will be Mathieu Fourtillan, Director of Ennov Clinical, and Phillip Strickland, Clinical Solutions Consultant. Ennov will be exhibiting at Booth 302.

Ennov EDC includes additional modules for Randomization, Medical Coding, EDC Mobile – an online/offline app available for the iPad. – as well as Import and Export tools and a Study Designer module. Ennov EDC can support clinical studies of any size, including very large and complex global trials. Data management teams can easily design, deploy and manage multi-center clinical study data with one comprehensive solution with no programming or advanced IT skills required.

Ennov Clinical is made up of several applications including: • Electronic Data Capture (EDC)Clinical Trial Management System (CTMS)Electronic Patient Reported Outcomes (ePRO) • Electronic Trial Master File (eTMF)

The Society for Clinical Data Management (SCDM) is an international non-profit organization of over 2,200 members created to advance the discipline of Clinical Data Management. The SCDM offers educational programs both in-person and online as well as producing some key publications. Last year’s SCDM Annual Conference drew around 1,000 attendees from over 300 life science companies.

About Ennov:

With over 15 years experience and 500 clients worldwide, Ennov has the industry’s most integrated, cost-effective and user-friendly Life Sciences platform. Our 4 connected solutions, Quality, Regulatory, Clinical and Pharmacovigilance, integrate with your workflow to help reach compliance and productivity goals faster, with no IT skills required. Headquartered in Paris, France, Ennov also has offices in Bordeaux and Poitiers, France, Cambridge, UK, as well as Greensboro, North Carolina in the US. Visit our website, www.ennov.com, to learn more about our comprehensive Life Sciences platforms.

September, 9-12, – Gaylord National Resort and Convention Center – RAPS 2017 Regulatory Convergence, National Harbor, Maryland

RAPS

Ennov, a Regulatory software vendor, exhibits its new Ennov 8 Platform and its Regulatory Software Suite at the RAPS 2017 Regulatory Convergence at the Gaylord National Resort and Convention Center (Stand 712), set to begin on September 9th.

Come meet us to also discuss best practices and proven results with Ennov eCTD software or to look at Ennov’s RIM (Regulatory Information Management) software which sets new standards for following up submissions globally to diverse authorities. Learn how you can optimize your regulatory affairs activity and face growing regulatory constraints and international pharmaceutical product deployments.

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization for people involved with healthcare regulation and products, including medical devices, pharmaceuticals, biologics and nutritional products.

The RAPS Regulatory Convergence is an annual multi-day gathering of the global regulatory community. It brings together the profession’s best and brightest to learn, grow, lead and share. RAPS’ Regulatory Convergence addresses today’s biggest challenges for regulatory professionals and regulators.

Location : The Gaylord National Resort and Convention Center, 201 Waterfront Street, National Harbor, Maryland 20745, USA

June, 18-22, – McCormick Place, Chicago, IL

DIA Chicago McCormick Place

Ennov, a Life Science software vendor, exhibits its Ennov 8 platform and our four turnkey solutions at the DIA 2017 Annual Meeting at the McCormick Place (Stand 640), set to begin June 18th.

We will present our newly updated Ennov Platform, as well as our Quality Management, Regulatory, Pharmacovigilance, and Clinical Software Suites. Ennov’s cloud-based and mobile software integrates with your business workflow to help you reach your compliance and productivity goals faster, with no IT resources required.

Learn more about our four turnkey solutions to manage Life Science companies’ documentation and processes.

DIA’s Annual Meeting on Driving Insights to Action is a 50 year tradition, serving as a global forum for all those involved in healthcare product development and life cycle management to exchange knowledge and collaborate. DIA is an essential resource that provides opportunities to extend debate and discussion to advance scientific and medical innovation, including technology to help you do so.

The goal of the DIA Annual Meeting is to provide you and your team with a rare opportunity to build on what you already know about the development of new therapies and to accelerate efforts to enhance health and well-being.

May, 1-3, – Charlotte Convention Center, Charlotte, NC ASQ

Ennov, a Quality software vendor, exhibits its Quality Management Software at the ASQ 2017 World Conference at the Charlotte Convention Center (Stand 318), set to begin May 1st.

We will present our integrated Quality Management Software Suite, a solution available as a cloud offer or as an on-premise solution, Ennov’s integrated QMS software helps our customer reduce quality management costs, achieve risk-based quality management, and comply with ISO and GMP requirements.

Learn how you can optimize your quality management activity with an all-in-one easy to use software solution.

Come meet us to discuss best practices and proven results with Ennov Document Management, Process Management, and Training management.

ASQ’s World Conference on Quality and Improvement is a 70-year tradition of sharing best practices and developing professional growth through tools, techniques, and methods.

The conference sessions will feature thought leaders and knowledge that best demonstrate the successes, tested solutions, and proven results these disciplines can bring.

This year’s “Grow your Influence” theme highlights how risk and change, quality fundamentals, and operational changes can be optimized and managed.

April, 3-5, – the Crowne Plaza Barcelona, Barcelona, Spain

ISPE barca

Ennov, a Regulatory and Quality software vendor, exhibits its Regulatory Software Suite and Quality Management Software at the ISPE 2017 Europe Annual Conference at the Crowne Plaza Hotel (Booth 13), set to begin April 3rd.

At the ISPE Annual Conference, we will be sharing our IDMP Whitepaper and present our eCTD247 solution which enables you to publish PSUR in eCTD format, as mandated by the EMA since June 2016. eCTD247 enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time. We will also be showing our RIM solution to meet your RA deadlines.

eCTD247 is the only online eCTD solution that

As a specialist of eCTD, Ennov has devised the most practical and cost effective solution for submitting PSUR in eCTD or NeeS format.

At the same time Ennov is sharing its integrated QMS software (cloud or on premise solution) which helps reduce quality management costs, achieve risk-based quality management, comply with GMP requirements at the ISPE conference.

Today’s industrial world is changing with digitization. The impact on the pharmaceutical world is increasingly felt. Change is taking place consistently, in all areas: more open production systems, more vulnerable to external attacks. The conference will address three focal points :

  • Results from the work of GAMP working groups:  Revised GAMP Good Practice Guidelines: verification of machine interfaces (M2M), amendment of the guideline for verification of the IT infrastructure, supplier audits
  • Production systems operation: treatment of deviation / Change Control, Audit Trail Review and decommissioning of systems
  • System and data security

ISPE’s Europe Annual Conference is a conference for leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.

This serves as the premier place for the discussion of processes, globalization, scalability, regulation and quality best practices including innovation and technology.

This years “Pharma Manufacturing 2025″s theme highlights how production, manufacturing, and the industry may change. Additionally, prominent questions will be explored and discussed such as what the main regulatory trends might be by 2025 and how will current technology platforms will evolve.

March, 29-31, – Scottish Exhibition & Conference Centre – SECC, Glasgow, Scotland

Dia Euromeeting

Ennov, a Regulatory software vendor, exhibits its Regulatory Software Suite at the DIA Euromeeting at the Scottish Exhibition & Conference Center (Stand B6), set to begin on March 29th.

Ennov has a comprehensive PV suite for Human and Veterinary drugs, including a complete pharmacovigilance database and analytics solution.

In the DIA Euromeeting, we will be sharing our IDMS Whitepaper and present our eCTD247 solution which enables you to publish PSUR in eCTD format, as mandated by the EMA since June 2016. eCTD247 enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time. We will also be showing our RIM solution to meet your RA deadlines.

eCTD247 is the only online eCTD solution and

As a specialist of eCTD, Ennov has devised the most practical and cost effective solution for submitting PSUR in eCTD or NeeS format.

DIA’s Annual EuroMeeting is an evolving conference which addresses the most pressing issues of today in Healthcare and the future.

This serves as the premier place for the discussion of processes, globalization, patients, and regulation including innovation and technology.

This year’s theme highlights the critical role patient input plays throughout the lifecycle of drug development. Additionally, the clinical content and “HTA, Value & Access” theme are more robust this year in recognizing the growing importance in the market.

February, 6-8, – Mariott Hotel and Conference Center, Bethesda, MD, USA

DIA Regulatory Submissions Information, and Document Management Forum

Ennov, a Regulatory software vendor, exhibits its Regulatory Software Suite at the DIA Forum at the Mariott Hotel and Conference Center (Booth 307), set to begin on February 6th.

Ennov has a comprehensive PV suite for Human and Veterinary drugs, including a complete pharmacovigilance database and analytics solution.

In the DIA 2017 Forum, we will be sharing our IDMS Whitepaper and present our eCTD247 solution which enables you to publish PSUR in eCTD format, as mandated by the EMA since June 2016. eCTD247 enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time. We will also be showing our RIM solution to meet your RA deadlines.

eCTD247 is the only online eCTD solution and

As a specialist of eCTD, Ennov has devised the most practical and cost effective solution for submitting PSUR in eCTD or NeeS format.

DIA’s Regulatory Submissions, Information, and Document Management Forum is the leading forum covering EDM (Electronic Document Management), ERS (Electronic Regulatory Submissions), and RIM (Regulatory Information Management) which represent the end-to-end process of managing regulatory submissions and documents.

This serves as the premier place for the discussion of emerging operational standards, best practices, and the processes for submission, creation, and maximum use of regulatory information, including the technology and processes.

This year focuses on the discussion of emerging operational standards, best practices, and the processes for submission, creation, and maximum use of regulatory information.

January, 23-25, – Mandarin Oriental Washington DC, USA

DIA conf 2017 Washington

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 January 23rd.

Ennov has a comprehensive PV suite for Human and Veterinary drugs, including a complete pharmacovigilance database and analytics solution.

In DIA 2017, we will present our eCTD247 solution which enables to publish PSUR in eCTD format, as mandated by the EMA since June 2016. eCTD247 enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time.

eCTD247 is the only online eCTD solution and

As a specialist of eCTD, Ennov has devised the most practical and cost effective solution for submitting PSUR in eCTD or NeeS format.

DIA’s Pharmacovigilance and Risk Management Strategies Conference is the leading forum for exploring insights into new technologies and innovative methods and how they can be utilized for pharmacovigilance in the broadest sense.

Optimizing benefit-risk is an important matter for all stakeholders, and must be done throughout the medicine life cycle. With the increased knowledge of technologic advances, new potential safety data sources and analytical methodologies, we have to be aware of the most efficient approaches.

This year focuses on innovation within the pharmaceutical industry – new therapeutic approaches, evolution of regulatory science that speeds needed products to prescribers and patients, and engagement of patients in the product development and regulatory processes.

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 / Web client

A simple and effective solution: eCTD247

eCTD247 enables you to submit your eCTD (or NeeS) dossier with the minimum effort and time.

eCTD247 also:

  • Is the only online eCTD solution
  • Has a pricing based on the number of documents in your submissions.
  • Is very easy to use, with minimal training time to become efficient and start publishing and submitting your eCTD

As a specialist of eCTD, Ennov has devised the most practical and cost effective solution for submitting PSUR in eCTD or NeeS format.

All inclusive submission service

If you do not have the time to edit your eCTD PSUR by yourself, we can also propose you an all inclusive service for your PSUR submission.

Please refer to the eCTD247.com web site or Contact us for more information. You will find a convenient FAQ that answeers all your questions regarding PSUR eCTD submissions.

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 cost Quality Management
  • Implement in one QMS SOPs, Deviations, CAPAs, and More

After registering, you will receive a confirmation email containing information about joining the webinar.

Ennov Quality Management System

November, 15-17, – Mannheim Dorint Kongresshotel, Germany

mhn_aussen-04

Discover Ennov’s Quality Management Offer at this year’s annual GAMP 5 2016 Conference, Booth 2 (15th & 16th of November) & 14 (17th of November) at the Mannheim Dorint Kongresshotel, Germany.

Ennov’s integrated QMS software (cloud or on premise solution) helps reduce quality management costs, achieve risk based quality management, comply with GMP requirements.

Meet us and discuss best practices and proven results with Ennov Document Management, Process Management, Training management.

Today’s industrial world is changing with digitization. The impact on the pharmaceutical world is increasingly felt. Change is taking place consistently, in all areas: more open production systems, more vulnerable to external attacks. The conference will address three focal points :

  • Results from the work of GAMP working groups:  Revised GAMP Good Practice Guidelines: verification of machine interfaces (M2M), amendment of the guideline for verification of the IT infrastructure, supplier audits
  • Production systems operation: treatment of deviation / Change Control, Audit Trail Review and decommissioning of systems
  • System and data security

November, 9-11, – Brighton Hilton Metropole, UK

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Ennov, a Quality software vendor, exhibits its Quality Management Offer at this year’s annual RQA Conference (Booth 18) at the Brighton Metropole Hotel, set to begin on November 9th.

On RQA 2016, we present our integrated Quality Management Software Suite. Available as a cloud offer or as an on premise solution, Ennov’s integrated QMS software helps our customer reduce quality management costs, achieve risk based quality management, comply with ISO9001:2015 and GMP requirements.

Learn how you can optimize your quality management activity with an all-in-one easy to use software solution.

Come meet us to discuss best practices and proven results with Ennov Document Management, Process Management, Training management.

RQA addresses quality in pharmaceuticals, agrochemicals, chemicals and medical devices. Since its beginnings in 1977, the Association has grown and developed to reflect regulatory changes, the impact of regulatory inspection and the changing structure and needs of industry. RQA’s purpose is to drive quality and integrity in scientific research and development.

The 2016 RQA Annual Conference will be held at the Hilton Brighton Metropole during the 9-11 November 2016. It will adress the theme “Quality: adding value”:

  • More risk based approaches
  • Greater transparency requirements
  • Increasing innovation
  • necessary cost reductions in organizations
  • Value added quality, greater proactive quality solutions

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 pharmacovigilance case database
  • Manage from 10 cases per year to over 100,000
  • Work on a hosted platform or install it on your premises

Our software is used by all types of human and veterinary companies, regulatory authorities and CROs.

After registering, you will receive a confirmation email containing information about joining the webinar.

Ennov PV Works interface

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 BLA submissions, regardless of your level of eCTD expertise.
  • With the eCTD 247 package, simple eCTD submissions can be published by yourself
  • For more complex submissions, you can get help by using our submission services.

With eCTD 247, the eCTD intelligence is embedded into the software itself in a simplified intuitive manner, thus saving you time, money and resources.

After registering, you will receive a confirmation email containing information about joining the webinar.

eCTD247 eCTD submission service

eCTD247 eCTD submission service

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 cost Quality Management
  • Implement in one QMS SOPs, Deviations, CAPAs, and More

After registering, you will receive a confirmation email containing information about joining the webinar.

Ennov Quality Management System

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 and IDMP vendor in a research note called “Delayed and Confusing IDMP Compliance Requirements Demand Life Science CIOs Pursue a Two-Part Strategy*”.

In this study, Gartner explains that

  • as the deadline for IDMP compliance is delayed, and IDMP regulatory guidance is currently unclear there is a “need for CIOs to implement an agile vendor and resourcing strategy to address uncertainty”.
  • There is a necessity to “Consider the MDM project requirements at the beginning, before going too far with a bolt-on regulatory information management system (RIMS) solution”.

Gartner also identifies 7 RIM vendors with IDMP offers (among which is Ennov).

RIM and IDMP are closely linked. To ensure a smooth path to compliance for its customers, Ennov provides natively integrated RIM and IDMP solutions.

About Gartner

Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

About Ennov

Ennov’s software suite enables Life Science companies to efficiently manage their regulated contents, and comprising Quality, Pharmacovigilance, Regulatory and Clinical content and process management.

Ennov has over 150 Life Science customers in more than 10 countries, including Caligor RX, Ceva, Horiba, Merck, Septodont, Virbac, Innothera, Air Liquide, Alchem, BASF, Charles River, GSK, Linde, Novartis, Supersonic Imagine, Transgene, Debiopharm, Unither. Pharmaceutical, biotech, medical device, cosmetics, specialty chemical and CRO companies trust Ennov’s solutions.

Please visit us at http://en.ennov.com

* Delayed and Confusing IDMP Compliance Requirements Demand Life Science CIOs Pursue a Two-Part Strategy, 2016
Published: 21 January 2016
Analyst: Michael Shanler

Contact

Olivier Pâris, Ennov oparis@ennov.com

Ennov a Recognized Vendor in 4 Different Technology Areas

Paris, France & Greensboro, USA – September 9th 2016

Ennov today announced it has been listed four times by Gartner as a vendor in the 2016 “Hype Cycle for Life Science Research and Development”*, and twice in the 2016 “Hype Cycle for Life Sciences”**.

This recognizes the relevance of Ennov’s products in the EDMS, RIM and Pharmacovigilance categories. The reports are available on the Gartner website at:

According to Gartner, Ennov is a sample vendor for the four following product categories in Life Science:

  • SaaS-Regulated EDMS (pages 23/24)
  • Global Regulatory Information Management (pages 67/68)
  • Global Pharmacovigilance/Safety/AERS (pages 71 to 73)
  • eTMF (electronic trial master file) (pages 60 to 63)

SaaS-Regulated EDMS and eTMF are considered in the study as high benefit technologies, with 2 to 5 years to mainstream adoption in the Life Sciences sector.

Global Regulatory Information Management is considered in the study as a moderate benefit technology, with 2 to 5 years to mainstream adoption in the Life Sciences sector.

Global Pharmacovigilance/Safety/AERS is considered in the study as a moderate benefit technology, with less than 2 years to mainstream adoption in the Life Sciences sector.

About the Hype Cycle for Life Sciences

The Gartner Hype Cycle studies assess the impact of emerging technologies for a specific market. Relevant technologies are positioned through their:

  • Development stage (Innovation Trigger, Peak of Inflated Expectations, Trough of Disillusionment and Plateau of Productivity)
  • Number of years to mainstream adoption
  • Average benefit for the industry (low, moderate, high, transformational)
  • Market penetration
  • Maturity level

A limited number of sample vendors are mentioned in each technology area.

About Gartner

Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

About Ennov

Ennov provides a suite of software that enable Life Science companies to manage their regulated contents in an efficient way. This suite comprises software for the management of Quality, Pharmacovigilance, Regulatory and Clinical contents and processes.

Ennov has more than 150 Life Science customers in more than 10 countries, and more than 100,000 users. Pharmaceutical & biotech, medical device, cosmetics, specialty chemical and CRO companies trust Ennov’s solutions for the improvement of their regulated content management.

Prominent Ennov customers include Caligor RX, Ceva, Horiba, Merck, Septodont, Virbac, Innothera, Air Liquide, Alchem, BASF, Charles River, GSK, Linde, Novartis, Supersonic Imagine, Transgene, Debiopharm, Unither. Please visit us at http://en.ennov.com

* Hype Cycle for Life Science Research and Development, 2016
Published: 19 July 2016
Analyst(s): Michael Shanler

** Hype Cycle for Life Sciences, 2016
Published: 19 July 2016
Analyst(s): Michael Shanler, Stephen Davies

Contact

Olivier Pâris, Ennov
oparis@ennov.com

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 paper to an electronic QMS
  • What you should prepare to bring in an electronic system
  • How to effectively evaluate different systems.
  • How an electronic Quality Management System can streamline your process

After registering, you will receive a confirmation email containing information about joining the webinar.

Ennov Quality Management System

September, 17-20, – The San Jose Convention Center, CA, USA

2016-RAPS-Regulatory-Convergence

Ennov, a regulatory affairs software vendor, exhibits its RIM software at this year’s annual RAPS Conference (Booth 401) at the San Jose Convention Center, set to begin on September 17.

On RAPS 2016, we present our new RIM (Regulatory Information Management) software. Available as a cloud offer or as an on premise solution, Ennov’s RIM software sets new standards for following up submissions globally to diverse authorities. Learn how you can optimize your regulatory affairs activity and face growing regulatory constraints and international pharmaceutical product deployments with an all-in-one easy to use software solution.

Come meet us also to discuss best practices and proven results with Ennov eCTD software.

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization for people involved with healthcare regulation and products, including medical devices, pharmaceuticals, biologics and nutritional products.

The RAPS Regulatory Convergence is an annual multi-day gathering of the global regulatory community. It brings together the profession’s best and brightest to learn, grow, lead and share. RAPS’ Regulatory Convergence addresses today’s biggest challenges for regulatory professionals and regulators:

  • Adapting regulatory frameworks and policy to respond to scientific advancement
  • Providing new, efficient pathways for product approval
  • Harmonization in countries that have traditionally taken vastly different approaches
  • Creating regulatory frameworks to encourage full competition and innovation
  • Building regulatory capacity
  • Talent management
  • Mergers and acquisitions

Location : The San Jose Convention Center, San Jose, 408 Almaden Boulevard, San Jose, CA 95110, USA

June 26-30, 2016 – Philadelphia, PA DIA 2016 Conference | Booth 1255

dia

Ennov is pleased to be an exhibitor again at the DIA 2016 Conference. Come to our booth to learn how our newly released RIM solution integrates seamlessly the management of regulatory documents, submissions, product registrations and processes.

The DIA is the largest global interdisciplinary gathering of professionals in the life science industry. The conference will be held in Philadelphia, PA on June 26 – 30 of this year with over 7,000 expected attendees; It is a great opportunity to meet thought leaders, and professionals and experts in the industry from around the world.

With over 15 years’ experience and 150+ life science clients worldwide, Ennov makes the most integrated, cost-effective and user-friendly compliance software for Life Sciences. Our 4 solutions: Quality, Regulatory, Clinical and Pharmacovigilance integrate with your workflow to help you reach your compliance and productivity goals faster, with no IT skills required.

For more information and to register for the event, click here

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 be published by yourself. For more complex submissions, you can get help by using our submission services. Compiling an eCTD submission is just the final step. The key is to have all documents ready on time and accessible. eCTD 247 is a cloud platform that helps you securely manage your regulatory content.

With eCTD 247, the eCTD knowhow is embedded into the software itself in a simplified intuitive manner, thus saving you time, money and resources.

The eCTD247 service is offered in three flexible and practical subscription formats: Essential (low number of submissions, price per sequence), Premium (large number of submissions, price per user) and Enterprise (on premise).

Find more about our eCTD247 platform.

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 RAPS Conference at the Baltimore Convention Center, set to begin on October 24.

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. – See more at: The RAPS Regulatory Convergence is an annual multi-day gathering of the global regulatory community. It brings together the profession’s best and brightest to learn, grow, lead and share. RAPS’ Regulatory Convergence addresses today’s biggest challenges for regulatory professionals and regulators:

  • Adapting regulatory frameworks and policy to respond to scientific advancement
  • Providing new, efficient pathways for product approval
  • Harmonization in countries that have traditionally taken vastly different approaches
  • Creating regulatory frameworks to encourage full competition and innovation
  • Building regulatory capacity
  • Talent management
  • Mergers and acquisitions

On RAPS 2015 for the first time ever, we present ourr exclusive new cloud-based service to build and track your eCTD submissions : eCTD 247 Simple, fast and cos effective ! Come meet us at Ennov Booth #312 to discuss about best practices and proven results with Ennov eCTD software solution while enjoying a French-style espresso .

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 which will be held June 14-18 at the Walter E. Washington Convention Center, and we hope to see you there! With over 7,000 attendees, the DIA Annual Meeting offers a great opportunity to meet with thought leaders and professionals from around the world, network, learn and build new relationships in one place.

Be sure to visit Ennov at Booth 1145 to learn more about our four turnkey solutions to manage Life Sciences companies’ documentation and processes from a single platform. Our cloud-based and mobile software integrate with your business workflow to help you reach your compliance and productivity goals faster, with no IT resources required.

For more information click here.

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 and Intelligence Annual Conference. In recent years, life sciences companies have been converging towards looking at regulatory as an end-to-end process. To meet these requirements faster and streamlines compliance with all regulatory standards worldwide, Ennov has developed a complete pre-configured Regulatory Affairs Solution available on-premises or in the cloud. Visit Ennov’s booth #100 to learn more about our off-the-shelf Regulatory software offer connecting natively an off-the-shelf Document management system, a robust publisher and a Regulatory Information Management System (RIM) on a single platform.

For more information click here.

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 2,500 quality experts from around the world at the ASQ’s World Conference premier international event. Connect and share ideas with your peers attending some of the 100 sessions and workshops demonstrating real-life cases and best practices.

Take some time to visit Ennov at Booth #334 to learn more about our off-the-shelf QMS solution while enjoying a French-style espresso with our quality experts.

For more information click here.

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)- PV-Works (Vet) user meeting will take place at the  Omni Richmond Hotel this year.

During the 3 day conference, Animal Health professionals – including representatives from a number of the North American Regulatory Authorities who are current PV-Works (Vet) customers – will gather with Ennov experts to learn, connect, and share valuable insights on key regulatory submissions topics, trends, signal detection strategy and new product releases. It is also a forum that offers our users the opportunity to give us their feedback and requirements for product improvements. Last year’s meeting in Charleston, SC attracted more than sixty attendees from fourteen different organisations. In addition to discussing a wide variety of hot topics, Assured made a well-received presentation of the new PV-Express offline data collection tool.

We look forward to seeing you very soon in Richmond.

 

 

 

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 PDA Annual Meeting is organizing plenary sessions and a series of parallel tracks which will feature more than 30 presentations and case studies from key industry leaders, including Adwait Bhagwat, Pricewaterhouse Coopers, and H. Gregg Claycamp, FDA, who will focus on the changing bio/pharmaceutical manufacturing landscape.

Come meet us at Ennov Booth #424 to discuss about best practices and proven results with Ennov cloud-based QMS.

For more information about the PDA annual conference program click here.

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 in North America where PV-Works is well established with many major customers in both animal and human healthcare including major regulatory authorities and CROs to monitor pharmaceuticals, biologicals, and medical devices.

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 Conference. This year the focus will be to explore the evolving global trends in e-records, systems and e-context in the Clinical & Regulatory space. The DIA along with an expert committee have developed this conference, which will feature plenary sessions on the latest trends and regulations. This conference will also serve as a forum for the discussion of emerging standards and the processes for submission creation and maximum use of regulatory information.

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 more businesses are required to consider and align to the standards of multiple sites. Electronic Management Systems is a way to address the challenge of bringing a solid structure and stability to harmonize organizations and management systems that touch and are touched by multiple countries and varying cultures. Today, more than ever, quality has become a fundamental pillar to every organizations. Within this setting, the 2015 World Conference On Quality and Improvement offers a forum of ideas and an international network of thought leaders, experts, and peers eager to share the best practices, tested solutions, and proven results. Come meet us at Ennov Booth to discuss about best practices and proven results for quality standards harmonization across your enterprise with Ennov Quality Software.

Come visit us at booth # 200.

For more information click here.

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 across the entire drug development value chain. The DIA along with an expert committee have developed this conference, which will feature plenary sessions on the latest trends and regulations. This conference will also serve as a forum for finding solutions within the exhibition with 2500+ other cross functional thought leaders. Come meet us at Ennov Booth to discuss about the benefits of an electronic document management system for quality, clinical trials, regulatory affairs or safety management.

For more information click here.

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