Introducing Medidata Adjudicate: A Unified Solution for Clinical Endpoint Adjudication

Single Digital Solution for All Clinical Trial Endpoints, Integrated with the Medidata Clinical Cloud

New York, New York - May 5, 2021 - Medidata, a Dassault Systèmes company, today announced the launch of Medidata Adjudicate, a state-of-the-art clinical endpoint adjudication system, fully integrated with the Medidata Clinical Cloud. This addition to the industry's leading end-to-end clinical development platform reinforces Medidata's unique ability to function as a one-stop shop for all clinical trial needs.

A single solution that follows all clinical events from beginning to final outcome, Medidata Adjudicate is designed to support investigator sites, contract research organizations (CROs), adjudicators, physicians, data managers, Clinical Event Committees (CECs), and sponsors who collect, manage, organize, adjudicate, and submit clinical endpoint data by providing:

• Full visibility into all trial events and status; real-time visibility is critical to ensure clinical events are moving through the adjudication process efficiently, and that sponsors and CROs have real time access to events
• Flexible reporting that allows users to monitor turnaround times and performance
• Self-service configuration that allows customers to perform their own trial builds. Medidata Adjudicate is one of the only solutions that allows sponsors and CROs to set up their own trials, maximizing efficiency and control; most solutions on the market require the technology provider perform the build, which can extend development timeframes and increase costs

Clinical endpoint adjudication is a standardized process for assessment of safety and efficacy of pharmacologic or device therapies in clinical trials. The adjudication process is needed to ensure that study findings can be trusted when clinical endpoints are subjective, complex to assess, or the study is geographically broad, leading to communication difficulties due to differing time zones and cultural contexts. When a clinical event occurs during a trial, the on-site investigator makes a judgement as to the type and nature of that event-but, as humans with different training, backgrounds and even biases, different investigators may have varying interpretations of the event in question.

Further, traditional manual, paper-based approaches to adjudication place significant time, cost, and resource burdens on organizations-and are prone to errors, bias, and regulatory issues. Because of this potential for human error and the quality risks associated with manual adjudication processes, a centralized, digital adjudication system is key in standardizing clinical data and the interpretation of that data, making overall study results more trustworthy. Integrating Medidata Adjudicate into the Medidata Clinical Cloud, it is now possible to compile the most complete record of every endpoint process, while eliminating problematic guesswork and reducing manual burden.

'With Medidata Adjudicate, we're able to help our customers and partners bring greater efficiency, accuracy, and value to the adjudication process in ways never seen before,' said Dr. Rama Kondru, EVP, CTO and head of product at Medidata. 'This technology is intentionally designed to support trial integrity and it's never been more important that sponsors, regulators, clinicians, and patients are able to trust the insights gleaned from clinical trials.'

Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.