OpenClinica, LLC and Shield Therapeutics announces that Shield Therapeutics has selected the OpenClinica Enterprise software for its clinical data management needs related to the company’s clinical trials. Shield Therapeutics develops treatments for unmet medical needs, and is currently running a Phase III program for ST10, a novel orally delivered ferric iron-based therapy to treat iron deficiency.
“The OpenClinica system should enable us to collect data from participating clinical trial sites faster and with a higher level of quality,” said Carl Sterritt, Shield’s CEO. “We also hope that an added benefit of the OpenClinica Enterprise Edition will be facilitation of our regulatory compliance efforts.”
OpenClinica offers a unique and flexible model for itsclinical trial software. “As commercial open source software, OpenClinica allows organizations like Shield Therapeutics to benefit from powerful, widely adopted, open source technology, while obtaining a fully supported implementation and a robust regulatory infrastructure, said Cal Collins, CEO at OpenClinica, LLC. “We are excited to welcome Shield Therapeutics to our rapidly growing community and Enterprise customer base.”
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.
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.
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.