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
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
November 20th 2024Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.
