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Tools for Clinical Trials Professionals
Web-based tracking and reporting tool removes the guesswork from trial management
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.
Northrop Grumman, (800) 874-2344, www.it.northropgrumman.com/clinicaltrialsIT
Meet the rigors of today's adverse event-reporting demands with a scalable, start-to-finish solution
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 SAFETYâ¢
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.
ArisGlobal, (203) 588-3000, www.arisglobal.com
New authoring release frees up even more time to tackle the meat of regulatory submissions
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.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
