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Northrop Grumman (Chantilly, VA) has introduced Global Trials Manager (GTM) for anyone who has been involved with a study that could have ended months earlier if only they had known the direction the results would ultimately take. This Web-based application is designed to help life sciences companies better manage and shorten the life cycles of clinical trials.

Global Trials Manager

GTM supports real-time tracking and reporting through a personalized site. This allows the processing of information to lead to faster decision making, improved project quality, and quicker time to market. From start-up activities to patient enrollment to the analysis of project metrics and results, GTM lets clinical trial professionals automatically respond to key data.

With GTM, Northrop offers an integrated planning and monitoring environment encompassing all aspects of a clinical trial. The software platform allows for tracking of data and project management plans detailing monthly progress as well as patient details, patient procedures, and patient-reported adverse events.

ArisGlobal (Stamford, CT) offers a suite of applications designed to meet the drug safety, pharmacovigilance, and risk management needs of pharmaceutical, biotech, and medical device companies as well as CROs. TOTAL SAFETY™ is a comprehensive, scalable solution designed to improve adverse event reporting throughout a product's life cycle. This type of advanced IT solution is currently in great demand, as life science companies find themselves under intense scrutiny by the public, health care professionals, regulatory agencies, and regulators.

TOTAL SAFETY™

The Web-based, user-friendly TOTAL SAFETY Suite includes: ARISg™, agXchange™, SafetyMart™, Safety Composer™, and ClinicalConnect™. All of the applications work in concert as a suite or can be used separately, depending on individual business needs. With the 21 CFR 11-compliant agXchange, TOTAL SAFETY™ enables life science companies to securely submit electronic documents with a thorough audit trail.

Each of the suite's programs is designed to integrate with most of the industry's technology infrastructures.

Given FDA's focus on eCTD submissions, Octagon Research Solutions, Inc. (Wayne, PA) saw an opportunity to enhance its authoring product with some added features. The company has released a new version of its StartingPoint authoring software that takes away even more of the burden of document formatting, allowing authors to focus on the critical content of regulatory submissions.

StartingPoint, version 2.0

The StartingPoint 2.0 package contains nearly 200 authoring templates spanning all five CTD modules, test scripts for clients to use when validating StartingPoint within their environments, a comprehensive user guide, and a style guide.

StartingPoint 2.0 features support for auto-numbered heading styles and quick-access buttons for commonly used tasks like adding captions, cross-references, and additional symbols. Also, Octagon has added a toolbar button to this version of StartingPoint that keeps unsupported or error-prone styles from corrupting the document.

Octagon Research Solutions, (610) 535-6500, www.octagonresearch.com.