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. 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.

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