Medidata Decentralized Clinical Trials (DCT) Program

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• Data management
• Data Quality Management

2021: Запуск Medidata Decentralized Clinical Trials (DCT) Program

On July 23, 2021, Medidata, owned by Dassault Systèmes, announced the launch of the Medidata Decentralized Clinical Trials (DCT) Program, a complex of unified and secure technologies that ensure the decentralization of the entire clinical research process.

Medidata has launched an end-to-end unified platform for decentralizing clinical research. Photo: shop.labprep.ru.

According to the company, the Medidata DCT program collects data on research participants remotely from anywhere and at any time. It combines and converts this data and monitors it to identify quality issues, mitigate risks, and ensure patient safety. In addition, it performs comprehensive analysis to obtain information to optimize trial results for patients, researchers, medical centers, funders, and contract research organizations.

In the biotechnology and research industry, as of July 2021, there is an increase in interest in decentralized testing tools, which are increasingly being introduced in the context of the COVID-19 pandemic. Funders and contract research organizations are increasingly turning to such models to optimize the availability of the clinical research process. told Anthony Costello, president of Patient Cloud at Medidata

With a variety of regulated capabilities within the Trial Dial concept, Medidata DCT provides an appropriate level of customization of decentralized solutions based on the research plan and protocol. This allows funders to customize and select different models, from traditional research in health centers to fully decentralized options and any hybrid regimens.

The Medidata DCT program helps rethink the paradigm of sponsorship of trials. This is achieved by providing support to sponsors and contract research organizations, as well as applying other approaches to research. Such methods are based on risk assessment rather than historical reactionary and ineffective practices on the ground. The built-in capabilities of Medidata DCT to identify, monitor and mitigate risks enable full digital surveillance. Moreover, the platform optimizes physical and virtual interaction with research centers, supporting patient safety and data quality. The Medidata DCT program also allows you to establish work processes taking into account the data of the trial participants, for example, deliver the investigated product directly to the patient and perform automatic dosage adjustment.

As of July 2021, Medidata applied its decentralized technologies to more than 44,000 clinical centers worldwide in several languages ​ ​ with the participation of more than 600 thousand patients with a wide variety of diseases. About 350 sponsors and contract research organizations trust Medidata to process the growing amounts of electronic data on trial participants obtained from modern research. A single platform minimizes the possibility of data discrepancies and delays in transmission that could lead to safety problems and increase the risk of research disruption.

According to Gartner, a research and consulting company, "IT directors of biomedical enterprises promoting digital optimization and modernization of the healthcare and biomedical industries should... Shape your technology strategy by prioritizing digital research solutions that combine wearables, mobile applications, the Internet of Things, and advanced data analysis. This will provide a truly patient-centric and decentralized approach to clinical research. "

The COVID-19 pandemic highlighted the key role of technology in accelerating the development of safe clinical research. In fact, Medidata technology has helped the COVID-19 vaccine undergo a full trial cycle in less than a year. To do this, the developer used a set of Medidata technologies, including Rave EDC (electronic data collection) solutions; eCOA (electronic assessment of clinical outcomes) and Detect (centralized statistical monitoring). These tools allowed research teams to adjust course before potential risks could affect the quality and timing of the study.

Regulators around the world are beginning to apply remote technology-based solutions as of July 2021, including monitoring, electronic informed consent (eConsent), telemedicine solutions, and direct delivery of investigational products to patients. Specifically, the U.S. Food and Drug Administration (FDA) is expected to issue draft guidelines for decentralized clinical research in 2021. The project will focus on endpoint analysis, data quality and control, and the proper use of electronic consent.