Life Sciences Software aids clinical trial results disclosure.

Press Release Summary:



Offered via SaaS model, PharmaCM CTR Express is comprised of modules to help clients in clinical trial registration and results disclosure, submissions planning and authoring, as well as structured product labeling. Solution complies with 21 CFR Part 11 and is fully pre-configured for accelerated deployment by Life Sciences organizations. Regulated content management software provides tools to manage drug product information critical to patient safety.



Original Press Release:



Intrasphere Technologies Launches PharmaCM CTR Express: a Comprehensive Clinical Trial Registration and Results Disclosure System Offered as a Pre-Configured, Quick-to-Deploy Solution



PharmaCM CTR Express Provides Life Sciences Organizations With a Cost-Effective Solution Complete With All Workflows and Reports Necessary to Manage and Simplify Complex Disclosure Processes

NEW YORK -- Intrasphere Technologies (http://www.intrasphere.com), a leading consulting and solutions firm that provides business-focused services and software solutions to Life Sciences organizations, announced today the launch of PharmaCM CTR Express for Clinical Trial Registration. PharmaCM CTR Express is a comprehensive clinical trial registration and results disclosure solution that is fully pre-configured for quick deployment. Offered as Software as a Service (SaaS), the solution is a fully validated application, hosted by Intrasphere and updated regularly to keep current with rapidly evolving trial disclosure requirements.

By subscribing to PharmaCM CTR Express, Life Sciences organizations are leveraging an optimally configured solution, based on the best approaches to trial disclosure developed in real-world settings over the past six years.

Suitable for any size Life Sciences organization, PharmaCM CTR Express is easily configured to support disclosure processes for both small and large teams. Developed and maintained to comply with 21 CFR Part 11, PharmaCM CTR Express provides subscribers with access to a validated solution that is updated regularly without additional work from their IT and compliance departments.

"Through its well-designed, intuitive user interface and proven workflows, PharmaCM CTR Express is designed to lower compliance risk and effort, by making complex disclosure requirements simple to manage," said Thomas Wicks, Product Manager, Intrasphere Technologies. "The solution is ideal for any size Life Sciences organization looking to streamline their disclosure processes. PharmaCM CTR Express is quickly deployed and requires minimal implementation support. Our clients' disclosure teams using the solution today were up and running, using the system within weeks of deployment," Mr. Wicks said.

About PharmaCM

PharmaCM is Intrasphere's comprehensive regulated content management software solution that enables users to overcome ineffective content authoring, management and distribution processes.

Organizations are provided with the tools necessary to manage drug product information that is critical to patient safety more effectively, including the content for drug labels, clinical trial protocols, and drug safety reporting in a user-friendly manner. Business users are empowered to create, manage, submit to regulators easily and intelligently reuse their information.

PharmaCM is composed of the following modules helping clients meet current and emerging regulatory content management challenges:

-- Clinical Trial Registration and Results Disclosure
-- Trial Information Dashboard
-- Submissions Planning and Authoring
-- Structured Product Labeling

About Intrasphere Technologies

Intrasphere is a consulting and solutions firm focused on the Life Sciences industry. We provide comprehensive, business-focused services and software solutions that help companies achieve meaningful results.

We have been helping clients to achieve desired results for over a decade by keeping their interests foremost in our minds at all times. The combination of our services and product strength coupled with our intellectual capital and character sets us apart as an industry leader.

Our professionals leverage strategic acumen, deep industry knowledge and proven project execution abilities to deliver superior service that builds true business value.

Intrasphere's strategy, business process and technology services are developed to address areas that are critical to clients' success including: Drug Safety, Clinical, Regulatory and Regulated Content Management.

Our experience enables us to intimately understand the unique nature of the Life Sciences working environment and clients' need to reduce costs, drive business processes and speed-to-market, while satisfying regulatory mandates.

Many of the world's leading global Life Sciences organizations look to Intrasphere as their trusted partner.

Contact:

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

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