eClinical Software: May 2009

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