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Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-01-01-2006, Volume 0, Issue 0

Tools for Clinical Trials Professionals

SAS offers a single platform for life sciences companies, eliminating integration headaches.

Say you're a typical life sciences company using a different point solution for each of your departments. This hybrid approach has not always been the best for the research and development process as a whole, since your organization must eventually spend valuable time and resources integrating these solutions.

Life Sciences Network

SAS (Cary, NC) has teamed up with CRO Constella Group, Inc., EDC software vendor DATATRAK, and eClinical software vendor etrials Worldwide to form Life Sciences Network Powered by SAS. Through the program SAS plans to work with selected vendors, CROs, and service providers to offer easier application integration to LS companies.

The network relieves organizations from the toils of IT integration by offering hosted and enterprise applications under one umbrella—a single platform for integrated solutions in key areas such as e-capture, patient diary systems, IVR systems, collection and reporting of lab results, safety and medical coding, as well as postapproval studies and registries.

SAS, 1-800-727-0025, www.sas.com/industry/pharma/develop/lsn.html

Clinical labs with smaller volume requirements have a workstation that fits their needs—and budgets.

Dynex Technologies, a division of Magellan Biosciences (Chelmsford, MA), has introduced a clinical diagnostic and biomedical research workstation within the reach of near-patient laboratories and other clinical labs with smaller volume requirements. The DS2™ System is a fully automated clinical diagnostic workstation designed to capture more accurate, immediate clinical diagnostic results at a lower cost than with full-fledged diagnostic systems.

DS2™ System

Designed for lower-throughput clinical labs, the DS2™ System features advanced automation and precise liquid-handling capabilities to eliminate variations common in manual processes. This allows clinicians to obtain accurate immunology to infectious disease analyses, hormone allergy, blood chemistry, etc. The workstation can process two 96-well microplates and up to 12 different assays simultaneously. It performs the entire complement of analytical steps needed for virtually any ELISA immunoassay, plus it has an advanced, user-friendly control system.

Magellan Biosciences, 978-856-2345, www.magellanbio.com

FDA partners with GlobalSubmit to deal with the expected deluge of eCTD submissions.

The FDA needed a robust electronic solution for handling the large number of anticipated Electronic Common Technical Document (eCTD) submissions. Enter GlobalSubmit's (Haddon Township, NJ) FDAreview software for reviewing eCTDs.

GlobalSubmit

Under a partnership arrangement, the FDA and GlobalSubmit will collaborate on the deployment and enhancement of FDAreview, which replaces the FDA's Electronic Common Technical Document (eCTD) Viewing System (EVS).

In the coming years, the FDA anticipates that a large number of pharmaceutical companies will submit documents using eCTD technologies, affording FDA reviewers quicker access to key information. The payoff for sponsors will be time and cost savings during the drug development process and during the preparation of documents for submission to regulators.

GlobalSubmit, 856-854-4455, www.globalsubmit.org