Document management suite gets training records tool with eCTD capabilities slated for V4.0
Document management suite gets training records tool with eCTD capabilities slated for V4.0
TAKE Solutions, Inc. (Princeton, NJ) stepped up the power of its PharmaReady document management suite by adding a training records management system in the software's version 3.0 release. The management software, which utilizes Microsoft Windows technology, is fully FDA 21 CFR Part 11, cGMP, and HIPAA compliant. It is designed specifically for SOPs, work instructions, training records, submission documents, and all other documents within FDA-regulated business areas.
Features present in the latest release include Active Directory authentication, email reminders, expanded reader assignment features, and advanced PDF publishing capabilities.
TAKE Solutions also announced launch plans for Version 4.0 to include fully structured product labeling and eCTD modules. Then, clinical documents stored in DMS today will automatically migrate into the eCTD module for compilation, publishing, and regulatory submission.
TAKE Solutions, Inc., (888) 993-1541, www.PharmaReady.com
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.
Novel Agent Shows Superiority Over Placebo in Reducing Monthly Migraine Days
September 5th 2024Lu AG09222 shows promise as first-in-class medication that prevents neurogenic inflammation, vasodilation, and parasympathetic lacrimation, which are considered to be surrogate markers of migraine attacks.