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
CAHtalyst Trial Shows Crenessity Sustains Efficacy in Classic Congenital Adrenal Hyperplasia
July 14th 2025Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.