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 firstname.lastname@example.org
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|SOURCE Intrasphere Technologies|
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