eClinical Software: May 2009
Applied Clinical Trials
The latest eclinical software in the clinical trials industry.
Document Authoring Template Updated
New features address complexity of global submissions standards
Octagon Research Solutions (Wayne, PA) has updated its global submission document authoring template suite to include over 230 templates.
StartingPoint 3.2 includes the following enhancements: Global Configuration File for Document Information Fields that allow for global settings to be preconfigured to minimize manual entry and ensure consistent naming conventions; Enhanced Physician's Labeling Rule Functionality, which offers flexibility in column format for editing and for delivering prescribing information; new templates that support ANDA submissions; and Table and Figure Numbering per Section that provides the option to number tables and figures either by document or by section.
Octagon Research Solutions, (610) 535-6500, www.octagonresearch.com
Storing SOPs for Regulated Industries
Secure document storage for SOPs available
Good Products (Nottingham, UK), a provider of Enterprise Content Management (ECM) solutions for the pharmaceutical, biotechnology, and medical device sectors, announces the addition of the new g-SOPs tool to its g-docs portfolio of document management solutions.
The software facilitates the creation, management, and storage of controlled documents related to Standard Operating Procedures (SOPs). g-SOPs allows users to create and manage SOP documentation and trigger automated workflows, including review and approval processes. Within g-SOPs, users can publish approved SOPs to the document library and access a full audit trail and complete document history. All SOPs and related documentation are securely stored within the g-SOPs module of g-docs. The g-SOPs tool is FDA 21 CFR part 11 compliant.
Good Products, +44 (0)115 912 4544, www.goodproductsltd.com
Regulatory Document Management Boost
Major version upgrade includes new module
NextDocs (King of Prussia, PA) announced Version 3.5 of its NextDocs Regulatory Document Management System. The upgrade includes a new module called the Clinical Documents Module that joins the SOP Management Module and the Regulatory Documents Modules as a component of the NextDocs Document Management System.
The solution addresses collaboration and document sharing between sponsors, investigators, site monitors, and vendors and includes support for scheduling and tracking of site monitor visits, documentation of investigational product protocols, and support for study documents such as investigator brochures, study protocols, 1572s, informed consent forms, and investigator CVs. The Clinical Module sits on the NextDocs Compliance Platform.
NextDocs, (610) 265-9474, www.nextdocs.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.
New Data Emerges from Phase IIb RELIEVE UCCD Study in Ulcerative Colitis and Crohn’s Disease
February 25th 2025Following initial positive results shared by Teva and Sanofi in December 2024, new data shows duvakitug (TEV’574/SAR447189) achieved higher rates of clinical remission compared to placebo in the advanced therapy-experienced subgroup.
