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Microsoft Cloud Authors: Pat Romanski, Srinivasan Sundara Rajan, Glenn Rossman, Janakiram MSV, Steven Mandel

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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.

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