A uniform digital solution for all endpoints of clinical trials, integrated with the Medidata Clinical Cloud
Medidata, a subsidiary of Dassault Systèmes, announced the launch of Medidata Adjudicate, a sophisticated endpoint examination system, fully integrated with the Medidata Clinical Cloud. This addition to the industry-leading end-to-end clinical development platform reinforces Medidata's unique ability to function as a comprehensive and complete solution for all clinical trial needs.
As a unified solution that tracks all clinical events from start to finish, Medidata Adjudicate is built to support investigator sites, contract research organizations (CROs), clinical trial adjudicators, physicians, data managers, clinical event committees (CECs), administrators, organizers, judges, and submitters. Clinical endpoints using:
- A complete presentation of all the events of the experiment and its status; Full real-time visibility is critical to ensure that clinical events move through the review process efficiently, and that sponsors and CROs have real-time access to events.
- Flexible reporting that allows users to track turnaround times and performance.
- A self-service configuration that allows customers to build their own experience. Medidata Adjudicate is one of the only solutions that allows sponsors and CROs to conduct their own trials, maximizing efficiency and control; Most of the solutions on the market require the technology provider to assemble the experiments, which may extend development schedules and increase costs.
Examining clinical endpoints is a process for evaluating the safety and effectiveness of treatments using drugs or devices in clinical trials. The examination process is necessary to ensure that the research findings can be trusted when the clinical endpoints are subjective, require complex assessment, or the study is geographically broad, which leads to communication difficulties as a result of working in different time zones and under different cultural contexts. When a clinical event occurs during the experiment, the researcher on the spot determines the type and nature of the event - but as people with different qualifications, backgrounds and even biases, different researchers may come to different interpretations of the same event.
In addition, traditional manual approaches to examination, based on paperwork, burden organizations with significant time, costs and resources - and are prone to errors, bias and regulatory issues. Because of this risk of human error and compromised quality associated with manual examination processes, a centralized digital examination system is key to standardizing clinical data and the interpretation of this data, making overall research results more reliable. Following the integration of Medidata Adjudicate in Medidata Clinical Cloud, the most complete documentation of each endpoint process can now be produced, eliminating the need for problematic guesswork and reducing manual workload.
"With Medidata Adjudicate, we can help our customers and partners bring greater efficiency, accuracy and value to the examination process in ways never seen before," said Dr. Rama Kundro, VP, CTO and Chief Product Officer, Medidata. "This technology was designed with the intention of supporting the integrity of the experiments. It has never been more important that sponsors, regulators, physicians and patients can trust the insights generated from clinical trials.”
Medidata is a wholly owned subsidiary of Dassault Systèmes, with its 3DEXPERIENCE platform, which is designed to lead the digital transformation of life sciences in the era of personalized medicine with the first scientific and business platform that includes the multitude of end-to-end developments, from research to commercialization.
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