Medidata Adjudicate

Main articles:

• Data management
• IT Project Management

Medidata Adjudicate is a single solution that allows you to track all clinical events from the beginning of the study to the final result. It is designed to support research centers, contract research organizations (CROs), the expert community, physicians, data management specialists, clinical event assessment committees (CECs), and clinical research funders. The solution enables the collection, management, organization, evaluation, and provision of endpoint data in clinical trials.

2021: Launch Medidata Adjudicate

Medidata announced on May 24, 2021 the launch of Medidata Adjudicate, a clinical endpoint assessment system fully integrated with the Medidata Clinical Cloud. This is an addition to Medidata, the industry's comprehensive platform for clinical research. It expands its capabilities and allows the platform to act as a single center for any tasks arising during clinical research.

Medidata Adjudicate provides:

• Full transparency of all events and current clinical research conditions. Transparency of real-time data is critical for effective analysis of clinical events during expert evaluation of the study. In addition, the solution allows funders and contract research organizations to access research data in real time.
• Flexible reporting capabilities that enable users to track time and performance.
• Self-customization so customers can create their own research schemas. Medidata Adjudicate is one of the few solutions that allows funders and contract research organizations to configure clinical research themselves, while ensuring high efficiency and control. Most decisions assume that the setup of the study scheme is not carried out by the research organization itself, but is made by the technology developer, which leads to an increase in the duration of the study and the corresponding costs.

Expert endpoint assessment is one of the standardized processes within clinical research that is used to assess the safety and effectiveness of drug treatment or therapy with medical devices. It is necessary so that the findings can be trusted when clinical endpoints are subjective or difficult to evaluate. In addition, this method is used if the study takes place in different regions, which leads to difficulties in communication due to the difference in time zones and cultural contexts. When a clinical event is observed during the analysis, the on-site researcher makes a judgment about its type and nature. However, since everyone has a different level of training, have different views and experience, interpretations of the same event may differ

Traditional approaches, with manual, paper-based endpoint assessments, significantly increase the time and cost of research and require additional resources. In addition, such a method often involves errors, biases and difficulties in complying with regulatory requirements. Due to the possible human miscalculations and risks that occur in traditional endpoint analysis and directly affect the quality of research, a centralized digital system for expert endpoint assessment is a key factor in data standardization and interpretation. In addition, this approach provides more reliable overall results of the study. By integrating Medidata Adjudicate with the Medidata Clinical Cloud, it is possible to collect the most complete data when analyzing each endpoint, while eliminating assumptions and reducing the burden on employees.

With the advent of Medidata Adjudicate, we can help our customers and partners improve the efficiency, accuracy and value of peer review through fundamentally different approaches, "says Dr. Rama Kondru, Executive Vice President, Technical Director and Head of New Product Development at Medidata. - This technology has been specifically designed to ensure the transparency and credibility of clinical research, it is important that research funders, regulators, treating physicians and patients can trust the information obtained during clinical trials.