Medidata to offer unified platform for decentralized clinical trials

Medidata, a company specializing in cloud-based solutions for clinical research, said Monday that it has launched an end-to-end unified platform providing a decentralized clinical trials (DCT) program.

Medidata said Monday that it has launched a unified platform that provides decentralized clinical trials (DCT) program.

The program provides direct-to-patient (DtP) services, such as technologies and workflows that help remote participation of clinical trial subjects, manage patient safety and data quality when monitoring, and facilitate drug delivery to biopharmaceutical companies and contracts research organizations.

Covid-19 has caused various changes in managing the safety of patients participating in clinical trials, delivering clinical trial drugs, and monitoring visiting subjects, Medidata said. In addition, due to the changing environments for conducting clinical trials, decentralized clinical trials have recently drawn attention as the participants and sponsors do not have to visit laboratories, it added.

The U.S. Food and Drug Administration is expected to publish guidelines for decentralized clinical trials this year, focusing on data quality and management and the use of appropriate electronic consent forms, Medidata said.

As an alternative to delayed clinical research, the Ministry of Food and Drug Safety has partially eased clinical regulations, including clinical trial drugs, remote consultation, and prescription. The Korea Health Industry Development Institute also reviewed the global health industry trends in October 2020 and highlighted the various advantages and possibilities of decentralized clinical trials.

Medidata said its decentralized clinical trial program supports remote data collection of subjects without limited time and space.

The collected data is immediately standardized and stored in an integrated platform through a process for subject safety and data quality and provides study insights for better outcomes to participants, researchers, testing institutions, CROs, and sponsors through analysis.

“We are proud as a trusted partner to the life science sector for more than 20 years to say that Medidata is now the only company providing a full suite of virtual capabilities to complete trial decentralization, encompassing both patient and site interactions,” Medidata Patient Cloud President Anthony Costello said. “Our program marks a significant evolution in the vision in how we can better serve patients and customers by accelerating research and bringing novel therapies to the market.”

Medidata stressed that nearly 350 biopharmaceutical sponsors and CROs have applied the decentralizing technologies across more than 44,000 clinical sites with over 600,000 patients worldwide. Medidata, which leads the decentralized clinical trials, plans to continue to help the industry to adopt novel technologies as needed, it added.