Welcome!

Cloud Expo Authors: Pat Romanski, Elizabeth White, Saar Bitner, Liz McMillan, Roger Strukhoff

News Feed Item

InnovoCommerce LLC Announces innovoPOINT cSafety Exchange™; Virtual Private Cloud-based Secure and Compliant Clinical Safety Reporting Distribution Solution

InnovoCommerce LLC, makers of innovoPOINT®, the world’s leading clinical and investigator portal product, announces innovoPOINT cSafety Exchange™, a compelling new virtual private cloud-based solution for secure and compliant safety report distribution, management and reporting. Clinical sponsors face increasing complexity managing global clinical trials. In addition to mounting pressure to accelerate site qualification and overall site activation time and maintain cost structure operationally, clinical sponsors must achieve greater efficiencies while promoting regulatory compliance with overall safety reporting. As clinical trials become more global and complex in nature and regulators further scrutinize safety event monitoring, sponsors now must utilize enterprise-class technology to distribute safety reports to investigator sites, institutional review boards (IRBs) and clinical research organizations (CROs).

innovoPOINT cSafety Exchange offers pharmaceutical and biotechnology sponsors, CROs and government and academic clinical sponsors a compelling turnkey solution for the secure and compliant web-based distribution, management and tracking of safety reports, documents and related serious adverse event information.

Built as an integrated product module in the innovoPOINT solution, and also accessible as a separate cloud-based service, the innovoPOINT cSafety Exchange offering enables the clinical sponsor and investigator to securely submit and track safety reports and documents in real-time. This accelerates the appropriate collaboration and information exchange when serious events occur during a clinical trial.

The solution, hosted and managed by InnovoCommerce, provides the following immediate benefits:

  • Compresses the time between receiving and disseminating safety reports and documents (such as safety letters and SUSARs).
  • Automatic notification of distribution lists, reports and acknowledgment of receipt.
  • Intelligent and accurate monitoring and reporting to ensure that safety reports are reviewed in an expeditious manner for the right compound, program, trial and investigator site.
  • Organizing and managing CROs and other clinical partners to ensure that safety information is disseminated, tracked and acknowledged.

The innovoPOINT cSafety Exchange offering is built on the Microsoft® SharePoint® 2010 platform, capitalizing on major investments global pharmaceutical companies are making in Microsoft’s market leading collaborative platform. This solution provides a comprehensive, value-added capability for clinical sponsors to manage safety report distribution, while accelerating and managing site qualification, site activation, study conduct and study close-out, all in an integrated and seamless user friendly environment. The turnkey offering includes dedicated qualified virtual private cloud infrastructure, validation and global support and monitoring services. Key features of the offering include:

  • Seamless integration with innovoPOINT clinical and investigator portal, all built with standardized Microsoft SharePoint technology.
  • Automatic distribution of safety reports/documents to investigators, IRBs and CROs, as well as other clinical partners such as biotech firms and government and academic research organizations.
  • Configurable rules-based workflow for therapeutic area, program, trial and country level targeting.
  • Audit reporting including safety report/document type, date and time of distribution, recipient delivery status.
  • Interfaces to leading serious adverse event systems for seamless external routing and distribution from underlying system via the innovoPOINT cSafety Exchange.

The innovoPOINT cSafety Exchange cloud offering is successfully deployed faster than any other solution on the market worldwide. InnovoCommerce provides the most advanced, out-of-the-box and configurable features and offers a turnkey virtual private cloud to ensure security, compliance and economical flexibility for clinical sponsor customers. innovoPOINT products can be installed and managed internally or delivered via InnovoCommerce’s SAS 70 type II compliant, US-EU Safe Harbor certified, GxP compliant national data centers.

About InnovoCommerce LLC

InnovoCommerce is the world’s leading company dedicated to Microsoft SharePoint-based eClinical software solutions. The company’s clinical trial management office (CTMO®) software suite includes the market’s leading clinical and investigator portal product, study management and clinical document management offerings. InnovoCommerce helps companies manage and control their clinical information value chain from site qualification through study close-out. All InnovoCommerce solutions can be installed on premise or utilized via a flexible, secure and compliant virtual cloud-based offering. Learn more about InnovoCommerce by visiting www.innovocommerce.com.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@CloudExpo Stories
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product Marketing Manager at Serena Software, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session a...
"Ulunsoft is a start-up that focuses on how enterprises build cloud-based IT infrastructure for business," explained Haibo Zhu, President of Ulunsoft Corp, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"At our booth we are showing how to provide trust in the Internet of Things. Trust is where everything starts to become secure and trustworthy. Now with the scaling of the Internet of Things it becomes an interesting question – I've heard numbers from 200 billion devices next year up to a trillion in the next 10 to 15 years," explained Johannes Lintzen, Vice President of Sales at Utimaco, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in San...
As enterprises engage with Big Data technologies to develop applications needed to meet operational demands, new computation fabrics are continually being introduced. To leverage these new innovations, organizations are sacrificing market opportunities to gain expertise in learning new systems. In his session at Big Data Expo, Supreet Oberoi, Vice President of Field Engineering at Concurrent, Inc., discussed how to leverage existing infrastructure and investments and future-proof them against e...
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"For over 25 years we have been working with a lot of enterprise customers and we have seen how companies create applications. And now that we have moved to cloud computing, mobile, social and the Internet of Things, we see that the market needs a new way of creating applications," stated Jesse Shiah, CEO, President and Co-Founder of AgilePoint Inc., in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"Desktop as a Service is emerging as a very big trend. One of the big influencers of this – for Esri – is that we have a large user base that uses virtualization and they are looking at Desktop as a Service right now," explained John Meza, Product Engineer at Esri, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Mobile commerce traffic is surpassing desktop, yet less than 20% of sales in the U.S. are mobile commerce sales. In his session at 15th Cloud Expo, Dan Franklin, Segment Manager, Commerce, at Verizon Digital Media Services, defined mobile devices and discussed how next generation means simplification. It means taking your digital content and turning it into instantly gratifying experiences.
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the ...
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"Application monitoring and intelligence can smooth the path in a DevOps environment. In a DevOps environment you see constant change. If you are trying to monitor things in a constantly changing environment, you're going to spend a lot of your job fixing your monitoring," explained Todd Rader, Solutions Architect at AppDynamics, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile ...
"SOASTA built the concept of cloud testing in 2008. It's grown from rather meager beginnings to where now we are provisioning hundreds of thousands of servers on a daily basis on behalf of customers around the world to test their applications," explained Tom Lounibos, CEO of SOASTA, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
“We are a managed services company. We have taken the key aspects of the cloud and the purposed data center and merged the two together and launched the Purposed Cloud about 18–24 months ago," explained Chetan Patwardhan, CEO of Stratogent, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core...
"Verizon Digital Media Services is responsible for the broadcast, video and content delivery network that accelerates, scales and helps our customers reach end users with all kinds of video and web content," stated James Segil, CMO of Verizon Digital Media Services, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Creative Business Solutions will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Creative Business Solutions is the top stocking authorized HP Renew Distributor in the U.S. Based out of Long Island, NY, Creative Business Solutions offers a one-stop shop for a diverse range of products including Proliant, Blade and Industry Standard Servers, Networking, Server Options and...
You use an agile process; your goal is to make your organization more agile. But what about your data infrastructure? The truth is, today's databases are anything but agile - they are effectively static repositories that are cumbersome to work with, difficult to change, and cannot keep pace with application demands. Performance suffers as a result, and it takes far longer than it should to deliver new features and capabilities needed to make your organization competitive. As your application an...
“We are strong believers in the DevOps movement and our staff has been doing DevOps for large enterprise environments for a number of years. The solution that we build is intended to allow DevOps teams to do security at the speed of DevOps," explained Justin Lundy, Founder & CTO of Evident.io, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.