CoSign Electronic Signatures delivered with DataLabs Site Manager 2.0
CoSign electronic signature reduces the time and cost of clinical trials, helping sponsors and CROs comply with the FDA's 21 CFR Part 11 and GxP regulations.
PHILADELPHIA-June 19, 2006-Algorithmic Research (ARX), a leading worldwide provider of electronic signatures and data security solutions, announced from the Drug Information Association (DIA) 42nd Annual Conference an agreement to integrate its CoSign electronic signature solution with DataLabs' Site Manager 2.0 collaboration software.
This integrated solution enables sponsors and CROS to electronically sign documents, forms and agreements using standard electronic signatures, which reduces the time and cost to clinical trials while complying with the FDA's 21 CFR Part 11 and GxP regulations.
DataLabs will be at booth #1829 at the DIA Annual Conference
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.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
