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
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.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
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.
