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
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.
Patient Engagement Platform Checklist
November 22nd 2024Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes. We put together this helpful checklist of key features to look out for when choosing a platform for your study.
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.
