|[December 31, 2012]
InnovoCommerce LLC Announces innovoPOINT cSafety Exchange™; Virtual Private Cloud-based Secure and Compliant Clinical Safety Reporting Distribution Solution
IRVINE, Calif. --(Business Wire)--
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).
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
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 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.
cSafety Exchange offering is built on the Microsoft (News - Alert)® 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.
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 (News - Alert)
70 type II compliant, US-EU Safe Harbor certified, GxP compliant
national data centers.
About InnovoCommerce LLC
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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