Intrasphere Technologies Releases Version 1.5 of Its PharmaCM Clinical Trial Registration...

* Reuters is not responsible for the content in this press release.

Tue Apr 7, 2009 7:57am EDT

Intrasphere Technologies Releases Version 1.5 of Its PharmaCM Clinical Trial
Registration Solution Powered by Microsoft

Enhanced Functionality Empowers Users to Take Full Control of the Entire
Clinical Trial Registration Process - from Assessment to Results Disclosure -
while Adhering to Changing Regulatory Requirements; Two Top-Ten Pharmaceutical
Companies Choose PharmaCM to Manage Their Clinical Trial Registration and
Results Disclosure Processes

NEW YORK, April 7 /PRNewswire/ -- Intrasphere Technologies
(http://www.intrasphere.com), a leading services firm that provides
business-focused services and solutions to Life Sciences organizations, today
announced the release of version 1.5 of the company's PharmaCM Clinical Trial
Registration (CTR) solution powered by Microsoft Office SharePoint Server
2007. New features include: enhanced validation for Basic Results
registration, bulk imports for Adverse Events, enhanced location management
and user-controlled workflows, among others. Intrasphere also announced that
two large global pharmaceutical organizations have signed on to use PharmaCM
CTR 1.5 to manage their clinical trial registration and results disclosure
processes. 

The enhanced features of the Clinical Trial Registration solution are a
next-generation set of tools that are developed to simplify what is currently
a complex, paper-based method of managing clinical trial registration.  The
latest features of version 1.5 include:

-- Enhanced validation: for clinical trials Basic Results that help to reduce
issues and feedback from ClinicalTrials.gov.

-- Adverse Events bulk import: to streamline the upload of Adverse Event data
to ClinicalTrials.gov.

-- Location management: to easily identify and manage site differences. 

-- Enhanced workflow: to accommodate complex decision trees and SOP's; to
provide increased control to better govern actions and next steps when making
data changes. Enables faster processing for routine or administrative changes
to registrations. 

"Regulatory agencies and organizations worldwide are increasingly requiring
Life Sciences organizations to register clinical trials and disclose results,
which increases the risks associated with non-compliance," said Woo Song,
Managing Partner and Co-Founder, Intrasphere Technologies. "The enhanced
features of PharmaCM's Clinical Trial Registration 1.5 helps these
organizations to effectively comply with increasingly complex and growing
global regulations in an efficient and auditable manner. The solution replaces
traditional manual and repetitive processes with an automated and secure
management system that ensures greater transparency and accountability of
accurate clinical trial information to the public."

"We are excited to have been chosen by both of the companies as their clinical
trial registration software provider. The new client additions is a testament
to the confidence the industry has in our solution," Song said.

The PharmaCM Clinical Trial Registration solution enables users to seamlessly
manage their clinical trials information and results disclosure with
controlled workflow and controlled release capabilities. Along with the
Regulatory Monitoring and Update service, the system is architected to
automatically monitor evolving industry requirements and implement changes as
needed to ensure ongoing compliance and support of new legislations and
registries. The solution is a core module of the company's PharmaCM Structured
Content Management suite which also comprises Submissions Planning and
Authoring and Structured Product Labeling modules.

The release of PharmaCM CTR 1.5 paves the way for integration of other
clinical information and documents into PharmaCM, such as Protocols and
Clinical Study Reports, so that information can flow easily and consistently
across the content value chain, from initial authoring to regulatory
disclosure.

Future PharmaCM Releases

Future releases for the PharmaCM Clinical Trial Registration solution will
include support for non-NIH registries (EudraCT), plug-ins for other
international registries and integration of an SOP management engine. For more
information contact us at +1 (212) 937-8300.

About Intrasphere Technologies

Intrasphere Technologies is a services firm focused on the Life Sciences
industry. We provide comprehensive, business-focused services and solutions
that help companies achieve meaningful results. Our professionals leverage
strategic acumen, deep industry knowledge and proven project execution
abilities to deliver superior service that builds true business value.

Our strategy, business process and technology services are developed to
specifically address areas that are most important to our clients including:
Drug Safety, Content Management and Portals, Structured Content Management
(PharmaCM), Corporate IT, Business Intelligence and Regulatory Compliance.

We understand the unique nature of the Life Sciences working environment and
clients' needs to reduce costs, drive business processes and speed-to-market,
while satisfying regulatory mandates.

Some of the world's leading global companies including Pfizer Inc., Johnson &
Johnson, Novartis, Eli Lilly and Vertex Pharmaceuticals look to Intrasphere as
their trusted solutions partner.

Founded in 1996, Intrasphere is headquartered in New York City with operations
in Europe and Asia. Intrasphere has been recognized nationally for performance
by industry-leading organizations such as Deloitte & Touche, Crain's New York
Business and Inc. Magazine.

    Contact:

    Annette DeCicco
    Intrasphere Technologies
    (212) 937-8213
    annette.decicco@intrasphere.com


This release was issued through eReleases(TM).  For more information, visit
http://www.ereleases.com.


SOURCE  Intrasphere Technologies

Annette DeCicco of Intrasphere Technologies, +1-212-937-8213,
annette.decicco@intrasphere.com
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.