News & Events
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 announce a new partnership that will provide an expanded portfolio
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 and Conference Center in North Bethesda, MD on February 10-12,
Managing post-approval CMC changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. A wide variety of stakeholders are involved, from manufacturing/supply change to corporate quality to regulatory affairs and regulatory operations. A diverse set of independent or loosely
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 to give you in this blog a short glimpse on
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 electronic format. Because a medical device premarket submission in electronic
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 on January 21-23, 2020. Both conferences focus on improving clinical
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 at the heart of the decision making process for pharmaceutical
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: Hype Cycle for Life Science Research and Development Hype Cycle
6 Considerations for Selecting an Electronic Data Capture (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 the small not so well known vendors, to homegrown EDC
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 large companies planning product divestitures, RIM provides a vital function.