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.”
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
Telemedicine Considerations When Conducting Decentralized Clinical Trials
January 14th 2025Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.