eClinical Software: November 2008
Applied Clinical Trials
The latest eClinical software in the clinical trials industry.
Send your new product info to: Kerri Nelen, knelen@advanstar.com
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
Send your new product info to: Kerri Nelen, knelen@advanstar.com
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
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.
STEP UP Trial Shows Semaglutide 7.2 mg Achieves Superior Weight Loss vs. 2.4 mg, Placebo
January 17th 2025Semaglutide 7.2 mg significantly outperformed semaglutide 2.4 mg and placebo with a 20.7% average reduction in weight and a comparable safety and tolerability profile, further establishing its efficacy in obesity treatment.
