Octagon Research Solutions Announces StartingPoint 4.0
Octagon Research Solutions, Inc., has released version 4.0 of its global submission document authoring template suite, StartingPoint.
StartingPoint 4.0 is designed to offer standardized templates and formatting functionality to those authoring the various components of a CTD (Common Technical Document) or eCTD (electronic Common Technical Document) regulatory submission. StartingPoint 4.0 offers new content templates, improved functionality and compliance with Windows 7.
New functionality includes:
* Enhanced error identification and management o
- Expanded list of errors highlighted by the Document Validation tool
- A new ‘Report Generation’ mode that enables the user to generate a comprehensive report of all errors found in the document.
- The addition of a ‘Replace All’ feature allowing replacement of all instances of erroneous style with one button push.
* Enhanced toolbar automation that addresses common challenges with table and footnote formatting
* Automated ‘Replace Styles’ functionality that allows the user to map each existing style in a document to a specified StartingPoint style.
* New and enhanced content templates reflecting recent changes in regulatory guidance including:
- 1.16 Proposed Risk Evaluation and Mitigation Strategies (REMS)
-1.16 Risk Evaluation and Mitigation Strategies (REMS) Supporting Document
-1.6.1 Meeting Request
-1.6.2 Pre-NDA Meeting Background Materials
“The Risk Evaluation and Mitigation Strategies (REMS) content template was added to this version of StartingPoint as a result of our agency interactions and is based on just released guidance from the FDA. We are seeing an increased emphasis on the REMS and felt it appropriate to include the content template to assist our clients in developing a framework for this critical document," stated John Lawrie, vice president, Process Consulting.
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.
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.
