Applied Clinical Trials
The latest eClinical software in the clinical trials industry.
Send your new product info to: Kerri Nelen, knelen@advanstar.com
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
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
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
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.