eClinical Software: November 2008

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Enterprise Document Management for the Lab

Collaborative agreement calls for product bundle for laboratories

NextDocs integrated document solution

Thermo Fisher Scientific (Woburn, MA) and NextDocs (King of Prussia, PA) have entered into an agreement whereby NextDocs Document and Compliance Suite will offer an extension of Thermo Fisher Scientific's laboratory information management systems (LIMS) and chromatography data systems (CDS) products.

The product will be sold by Thermo Fisher Scientific under the NextDocs name and will offer fully integrated informatics and a content management solution that complies with FDA 21 CFR Part 11, GMP, GLP, GCP, and other regulation and industry standards.

The NextDocs suite is built on the Microsoft SharePoint 2007 platform.

Thermo Fisher Scientific, (781) 933 4689, www.thermo.com/informatics

Product Registration and Labeling Integrated

Solution addresses life sciences end-to-end global product tracking

Aris Global (Stamford, CT) and i4i (Toronto) have integrated their products: ALiCE 4 Labeling (A4L) from i4i and Aris Global's Register.

Aris Global and i4i joint product manager

A4L is an XML-based product label and authoring application, while the Register solution offers a central repository for managing the end-to-end tracking of global product registration details and submissions. The integrated applications will provide a comprehensive solution for centrally managing products, tracking and planning global registrations, and addressing all authoring and lifecycle management aspects of e-label production.

The joint solution enables organizations to manage and track updates and variations to determine any regulatory impact of proposed changes.

Aris Global, (203) 588-3000, www.arisglobal.com

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Metadata Management Added to Suite

Module targets data management and transfer for teams

Image Solutions, Inc (ISI) (Whippany, NJ) announced its new module—ISI Submission Manager (ISM)—to its integrated regulatory solution suite. The module targets metadata and the relationship between submissions and allows regulatory teams to manage and transfer data between submissions, as well as create reports based on submission status from eCTDXPress and ISIPublisher, ISI's products that manage eCTD, paper, and non-eCTD electronic submissions. The suite is now integrated on a single platform.

Image Solution ISI Submission Manager

There are two key components to ISM. The first allows users to access outline views for all of the eCTDXPress applications/submissions. The second component, Metadata View, allows users to view hierarchy, Regional, ICH, STF, and custom metadata associated with each publication or submission.

ISI, (973) 560-0404, www.imagesolutions.com

Send your new product info to: Kerri Nelen, knelen@advanstar.com