The introduction of Medidata Risk Management in conjunction with updates to Medidata Detect round off a complete suite of unified RBQM solutions based on Medidata Clinical CloudTM

NEW YORK – (BUSINESS WIRE) – Medidata, a Dassault Systèmes company, announces Medidata Risk Management, the latest addition to its Risk-Based Quality Management (RBQM) suite, a holistic suite of solutions designed to streamline the introduction of proactive clinical action activities for operational monitoring. These include centralized monitoring, reduced source data review (SDV) and source data review (SDR), remote source document review, and performing decentralized testing activities.

RBQM practices enable clinical operations teams to remain flexible and agile in the complex environments of the ever-changing clinical development landscape. The Medidata Risk Management available today is the fundamental step in enabling a comprehensive RBQM strategy. Medidata Risk Management is based on the Medidata Clinical Cloud ™ and is fully integrated into Medidata’s centralized monitoring tool Medidata Detect. It supports sponsors and contract research organizations (CROs) in the identification of critical data and processes, the associated risks and the implementation of mitigation strategies according to ICH E6 (R2). With the latest updates to Medidata Detect, study teams can now also compare location differences between all participants to easily reveal trends or anomalies and determine if there are any discrepancies in data collection or the integrity being investigated.

“The COVID-19 pandemic has prompted sites, sponsors and CROs to take remote and risk-based approaches to ensure study participant safety, good clinical practice (GCP) compliance, and risk to study integrity to minimize, “said Lisa Moneymaker. Vice President, Clinical Operations Technology at Medidata. “Our goal was and is to drive innovations and solutions in this area so that we can support sponsors and CROs with the skills they need in their toolbox for clinical operations – so that they can best support sites and patients. ”

Instead of maintaining risk assessments in isolated tables, study teams can work together in the Medidata Risk Management template library for greater efficiency. These templates include the TransCelerate Risk Assessment and Categorization Tool (RACT), a Medidata-authored COVID-19 risk assessment, and a decentralized study template created and developed by the Association of Clinical Research Organizations (ACRO) and companies on it Area can support special issues and focus areas if they switch to the decentralized and virtual test area.

Medidata Risk Management is based on the Medidata Clinical Cloud and offers access to a range of solutions for optimizing data collection, data management, study planning and administration, and analysis. The solution uses the Quality by Design (QbD) approach to monitor early quality indicators, including QTLs (Quality Tolerance Limits) and KRIs (Key Risk Indicators), prior to the start of a clinical trial. This proactivity ensures that the defined risk control mechanisms effectively reduce the identified risks.

Risk management is built right into Medidata Detect so study teams can proactively monitor known risks and identify anomalies, trends and even unknown risks earlier with real-time data flow and on-demand data updates. Detect uses the KRIs and QTLs from the risk management solution to develop dashboards for problem management and to make anomalies visible, which can be incorporated for further details. Now study teams can proactively evaluate issues that are outside of the tolerable range to determine if corrective action is needed.

Medidata is advancing technology to support excellence in conducting studies and enabling companies to achieve digital surveillance that the company sees as the future of clinical operations. The goal is to help CROs and locations create efficiency and prioritize patient safety while sponsors invest in innovative solutions for global health and reduce time to market.

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

About Medidata

Medidata is leading the digital transformation of the life sciences, creating hope for millions of patients. Medidata helps generate evidence and intelligence to help pharmaceutical, biotech, medical device, and diagnostic companies, as well as academic researchers, add value, minimize risk, and optimize outcomes. More than one million registered users from more than 1,700 customers and partners access the world’s most widely used platform for clinical development, commercial and real data. Medidata, a Dassault Systèmes company (Euronext Paris: # 13065, DSY.PA) is headquartered in New York City and has offices around the world to meet the needs of its customers. Learn more at www.medidata.com and follow us @Medidata.

Medidata is a registered trademark of Medidata Solutions, Inc., a wholly owned subsidiary of Dassault Systèmes.

About Dassault Systèmes

Dassault Systèmes, the 3DEXPERIENCE company, is a catalyst for human progress. We offer companies and people collaborative virtual 3D environments to imagine sustainable innovations. By creating virtual experience twins of the real world with our 3DEXPERIENCE platform and applications, our customers are pushing the boundaries of innovation, learning and production. Dassault Systèmes offers added value to more than 290,000 customers of all sizes, in all industries and in more than 140 countries. More information is available at www.3ds.com.

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contacts

Caroline Printer

Senior Director, Head of Corporate Communications

+ 1-347-675-3222

cdrucker@medidata.com

Paul Oestreicher

External Communications Director

+ 1-917-522-4692

poestreicher@medidata.com

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