New York, NY (PRWEB) March 24, 2009
Intrasphere Technologies (http://www.intrasphere.com), a leading consulting firm that provides business-focused services and solutions to Life Sciences organizations, announced today that Thomas Wicks, Business Development Manager, will serve as a panelist at a session titled; "Assess the Benefits and Applications of Utilizing Technology to Manage the Disclosure Process", during CBI's 4th Forum on Clinical Trial Registries and Results Databases. The conference takes place on April 21-22, 2009 in Arlington, Virginia at the Westin Arlington Gateway Hotel. During the conference, Intrasphere will also exhibit and feature its PharmaCM Structured Content Management solution.
Wicks' session, scheduled for April 22, 2009, 1:45pm EST, will be moderated by Pamela A. Rose, Associate Director, Clinical Trial Registration and Results Disclosure, Takeda Global Research & Development Center, Inc.
As regulations governing the clinical data disclosure process become more stringent, it's becoming increasingly difficult to remain compliant. However, many organizations have begun implementing emerging technologies designed to manage the disclosure process. During the discussion, the panelists will field questions from the audience, discuss their experience with enabling technology and provide answers to the following questions:
- What does the technology need to be able to do?
- Where is it best to use technology?
- What tasks should be completed by humans instead of technology?
- How do you encourage management-buy in?
o how can you build the business case for this technology
- To what degree do you connect to source systems?
o CTMS, SAS
- Should this be a hosted or installed solution?
o third party host, build or buy?
"Regulations that govern clinical trials disclosure for Life Sciences organizations continue to increase and as a result, risks, liabilities and complexities surrounding the processes continue to pose challenges. Implementing the right technological solution can help these companies not only save time and money, it can also enforce compliance and drug safety." said Thomas Wicks, Business Development Manager, Intrasphere Technologies. "We're confident the session will provide attendees with a comprehensive assessment of various technologies that can help to manage clinical trials disclosure in an efficient and predictable manner."
At the conference Intrasphere will demonstrate its PharmaCM Clinical Trial Registration Solution which helps Life Sciences organizations gather accurate clinical trial information and easily manage the complex process of authoring, reviewing, approving and uploading study content to ClinicalTrials.gov and International Registries. Users are provided with all the necessary tools and functionality to provide open and timely disclosure of clinical trial results.
In order to help the industry remain up-to-date on the latest trends and regulations, CBI organizes an annual event on Clinical Trial Registries and Results Databases. The event perennially attracts decision makers like Vice Presidents or Directors/Managers at pharmaceutical, biotech or medical device companies, and provides the attendees with excellent networking opportunity.
PharmaCM is a comprehensive structured content management solution powered by Microsoft Office SharePoint Server 2007. The solution 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 easily create, manage, submit to regulators and intelligently reuse their information.
PharmaCM is composed of three different modules helping clients meet current and emerging regulatory content management challenges:
- Submissions Planning and Authoring
- Clinical Trial Registration
- Structured Product Labeling
About Intrasphere Technologies
Intrasphere Technologies, Inc. (http://www.intrasphere.com) is a consulting firm focused on the Life Sciences industry. We provide comprehensive, business-focused services 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, to name a few.
We 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.
Some of the world's leading global companies including Pfizer Inc., Johnson & Johnson, Novartis, Eli Lilly and Vertex Pharmaceuticals, among others, 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.
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