Medidata Risk Management

Main articles:

• Data Quality Management
• Data management

2021: Announcement of Medidata Risk Management

On April 28, 2021, Medidata the company owned Dassault Systèmes by introduced the solution Medidata Risk Management, which supplemented its package of tools for a risk-based approach to quality management (RBQM). They are designed to optimize the implementation of proactive measures to oversee clinical research. This suite of solutions helps centrally monitor, optimize data source data verification (SDV) and source review (SDR) procedures, analyze remote source documents, and conduct decentralized research.

Medidata Risk Management

According to the company, the solution Medidata Risk Management is an element in the implementation of a comprehensive strategy of risk-oriented quality management. It is based on Medidata Clinical Cloud's cloud-based clinical data platform and is fully integrated with Medidata Detect's centralized monitoring tool. This solution is designed to help sponsors and contract research organizations (CROs) identify critical data, processes, and associated risks, as well as take countervailing measures to mitigate these risks according to the ICH E6 (R2) standard. Recent updates to Medidata Detect allow research teams to compare data from all project participants in different research centers. Thus, they can identify trends and anomalies, as well as possible discrepancies in the collection of data or their integrity, for later examination of these discrepancies.

The COVID-19 pandemic has pushed medical facilities, clinical research sponsors, and contract research organizations to implement remote and risk-oriented approaches. This allows for the safety of clinical trial participants and adherence to good clinical practice (GCP), as well as minimizing risks affecting research integrity. told Lisa Moneymaker, VP Clinical Research Technologies at Medidata

Instead of performing risk assessments in separate spreadsheets, research teams will be able to use the template library in Medidata Risk Management. These templates turn on the TransCelerate tool for assessment and a categorization of risks (Risk Assessment and Categorization Tool, RACT) the created Medidata for risk assessment of COVID-19. In addition, the solution includes a Decentralized Clinical Trials (Decentralized Trials) template created and developed by the Association of Clinical Research Organizations (ACRO). It is designed to help companies solve highly specialized problems in certain areas as they move to decentralized and virtual clinical research.

Medidata Risk Management was built on the Medidata Clinical Cloud platform, providing customers with access to a range of tools to optimize data collection, analysis, and management, planning, and research management. The solution uses the principle of "Quality by Design" (QbD) to monitor key quality indicators, including permissible values ​ ​ of quality indicators (QTL) and key risk indicators (KRI), even before the start of clinical research.

Risk Management is fully integrated into Medidata Detect, enabling research teams to proactively and independently track known risks and detect anomalies, trends, and even unknown risks at an earlier stage. In this way, they are assisted by real-time data flows, as well as the ability to update data on demand. KRI and QTL metrics from Risk Management are used in the Detect tool to create problem management panels and visualize anomalies. They can also be detailed for more information. Now, research teams can independently evaluate cases of controlled parameters going beyond the allowable range to determine whether corrective action is necessary.