medidata rbm risk-based monitoring in the clinical cloud

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07/2015 FACT SHEET

Medidata RBM: The Fastest Way to Realize the Quality, Cost and Timeline Benefits of Risk-based Monitoring

Can a risk-based monitoring (RBM) solution go beyond saving money and actually improve data quality and accelerate treatments to market? Medidata says, “Yes!”

On-site monitoring, especially source data verification (SDV), accounts for about 30% of the $7.5 billion spent annually on clinical trials. Two recent studies indicate that a 100% SDV approach results in changes to less than three percent of data , and the percentage of SDV queries that generated on critical data averaged only 2.4 percent. That means thousands of hours of monitoring time and more than $2 billion spent on 100% SDV has little impact on clinical trial data quality.

RBM includes the practice of targeted monitoring and data quality efforts to where errors are most likely to occur. Industry bodies and regulators increasingly recognize that RBM can reduce clinical trial costs and even help to accelerate treatments to market without sacrificing data quality. Despite this promise, getting started with RBM has been a significant challenge for many sponsors and CROs.

Medidata RBM offers a holistic, intelligent monitoring solution that addresses this challenge by providing the fastest way to realize the quality, cost and timeline benefits of risk-based monitoring.

What is Medidata’s RBM Solution?Medidata empowers biopharmaceutical companies and CROs to plan, execute, analyze and adjust their studies using a closed-loop adaptive process. With Medidata RBM you can:

• Get immediate benefit

• Work seamlessly with Medidata Clinical Cloud®

• Achieve deep sustainable value

The solution identifies risks and helps reduce the time and cost involved with on-site monitoring by quickly identifying suspect data. This enables our customers to concentrate resources on high-risk areas, thereby improving data quality. Medidata RBM works by providing the capabilities and services required to manage data accuracy, integrity and risks throughout the life cycle of a clinical trial. The solution can also help to find “needles in the haystack” by exposing anomalous data, underreported events, protocol deviations, and even fraud and data fabrication.

Medidata empowers biopharmaceutical companies and CROs to plan, execute, analyze and adjust their studies using a closed-loop adaptive process.

207/2015 FACT SHEET MEDIDATA RBM: THE FASTEST WAY TO REALIZE THE QUALITY, COST AND TIMELINE BENEFITS OF RISK-BASED MONITORING

Study sponsors and CROs that entrust their study data to Medidata RBM will realize immediate and sustainable benefits. Here’s how:

Get Immediate BenefitMedidata RBM enables clinical trial sponsors and CROs to get immediate value by reducing their dependence on expensive and often inefficient, sometimes ineffective manual processes associated with traditional on-site monitoring.

Centralized Statistical Analytics (CSA), a component within the RBM solution, can analyze up to 1 million data points and find over 4,000 patterns in less than an hour. This technology enables the creation of robust patient profiles and longitudinal views of clinical data across all sites and all subjects for a given study. CSA then automatically identifies anomalies, outliers, unexpected errors, potential fraud and procedural issues to identify areas of risk based on clinical study data. CSA also summarizes overall risks and identifies sites that need further investigation. All this is achieved without configuration or need to identify key risk indicators (KRIs) during set up. The CSA program identifies the risks and tells the user exactly where to find them.

Medidata TSDV (targeted source document verification) is a unified, electronic data capture (EDC)-based tool that allows life science companies to efficiently and compliantly reduce the amount of SDV conducted. Its configurable, statistical algorithm lets you control your level of SDV coverage—without sacrificing regulatory requirements. Medidata TSDV lets study teams configure study-specific and site-specific SDV plans—all the way down to the data field, form and patient visit levels. The embedded statistical algorithm automatically assigns patients to pre-configured SDV regimens as they are enrolled, enabling the study team to achieve desired coverage levels. As the trial progresses, the team can make modifications at any level without disruption.

Targeted monitoring (powered by targeted SDV) allows users to execute on their monitoring plans and risk strategies with real-time guidance from Medidata RBM’s analytics capabilities (e.g., CSA, KRIs). Targeted monitoring improves on-site monitoring efficiency by allowing users to define and configure the critical data that must be monitored. A configurable interface allows real-time adjustment to the SDV at the field level within your eCRF (see Figure 1).

Figure 1. Real-time configurable dashboard allows adjustment of SDV levels.

A holistic view from multiple data sources enables Medidata RBM users to identify risks. These include study-level risk analytics, site quality and operational analytics that identify variations on data quality at a site, protocol compliance and subject retention.


Site- and Study-level Key Risk Indicators (KRIs) fueled by operational data from the Medidata Clinical Cloud KRIs provide a real-time view of site performance and behavior. In combination with clinical data analysis provided by CSA, Medidata RBM provides a powerful holistic view of site performance and data quality ( see Figure 2).

With this level of intelligent monitoring, customers can reduce the number of site visits and associated costs. Monitoring plans may also be adjusted or changed as the trial progresses based on intelligence from CSA and study- and site-level KRIs. Customers can rapidly reduce monitoring costs by 20 percent to 30 percent by minimizing visits to low-risk sites while maintaining a higher visit schedule for higher risk sites (see Figure 3).

Quick-start consulting and assessment services Gets you out of the gate with the basics of RBM business process planning. If you already have a RBM process in place, we can help optimize to drive optimum value. Enablement services are designed to help you create patient profile design by selecting variables to simplify the profile. Get your clinical trial started in just weeks through CSA design and configuration, selecting variables and defining the patient profile. Targeted monitoring enablement workshops provide guidance in designing and creating study and site-specific SDV plans. We can also provide workshops to help you identify data anomalies and sources of risk in clinical data such as fraud and data fabrication, unreported or inaccurately reported data, and protocol deviations as outputs of the engagement.

Figure 2: Study- and site-level dashboard views enables real-time monitoring of KRIs

Figure 3: How Medidata RBM helps rapidly reduce monitoring costs


Seamless InteroperabilityMedidata RBM seamlessly interoperates with Rave EDC and the Medidata Clinical Cloud to provide a single source of truth to help ensure quality and compliance. Real-time data from EDC, CTMS, central laboratory, and other source systems flow into the unified database to enable comprehensive risk analysis. Robust audit trail capabilities in the RBM platform enable sponsors and CROs to control and align monitoring activities in accordance with their regulatory strategies. Lastly, unified analytics are updated in real-time to allow risk assessment and changes to SDV levels during the trial.

A holistic view from multiple data sources enables Medidata RBM users to identify additional risks. These include study-level risk analytics that provide an overall assessment of risk – including identification of unreported or missing data – site quality and operational analytics that identify variations on data quality at a site, protocol compliance and subject retention. In addition, safety and data anomaly analytics identify potential fraud and fabrication of data.

An intelligent and adaptive process identifies and qualifies risks that require immediate action. Study dashboards enable users to drill down and view risks and discrepancies by site, variable and subject, providing the ability to view overall site quality, performance, fraud, and data integrity (see Figure 4).

Achieve Deep and Sustainable ValuePowerful algorithms, informatics and business intelligence provide a patent-pending set of machine, self-learning algorithms that define and derive risks based on actual study data. Site quality analytics and KRIs are normalized at the site level to detect signals reliably, while a rolling window examines errors, outliers and anomalies to identify whether an issue is a single occurrence or indicative of a trend. Meanwhile, a robust business intelligence solution defines, derives and manages the KRIs before and during clinical trials. Through decreased monitoring and travel costs and the identification and correction of errors and inefficiencies, Medidata RBM customers can realize millions in savings on an ongoing basis.

Powerful algorithms, informatics and business intelligence provide a set of machine, self-learning algorithms that define and derive risks based on actual study data

Figure 4: Real-time monitoring of risk help improves data quality


Beyond the immediate value, biopharmaceutical companies and CROs will realize ongoing benefits from the Medidata RBM solution. With over 20 years of industry experience, Medidata’s life science consulting teams offer business process optimization (BPO) and change management consulting to drive transformational change. Offerings include advisory services to support transformational change in process, organization and technology as well as RBM strategic consulting services to expedite adoption and value realization of RBM. These Medidata RBM services are designed to accelerate the adoption of RBM and/or optimize an existing program to provide deep, sustainable value from RBM.

Medidata’s RBM Solution: A Catalyst for Success Medidata RBM provides the fastest course to effective risk-based monitoring through:

• Statistical analytics that turns on in days to create robust patient profiles and identify data anomalies across the clinical study.

• Targeted monitoring guided by real-time analytics driven by Medidata RBM analytics capabilities (CSA, KRIs)

• Industry benchmarks that allow customers to compare their performance to industry peers using KPIs such as query rate, data correction, SDV% and SDV velocity of their RBM study

Lastly, Medidata RBM supports the study by finding the unknown risks that can be hidden in clinical and lab data. Only CSA can find the needles in the haystack and ensure exposure of discrepant data so that risks can be proactively mitigated. These risks include under-reported adverse events (AEs) such as protocol deviations, fraud and data fabrication (see Figure 5).

Discover what leading biopharmaceutical companies and CROs all over the world have already learned based on their experience with the Medidata RBM platform: it is the fastest way to start realizing the quality, cost and timeline benefits of risk-based monitoring.

Figure 5: Medidata RBM helps identify known and unknown risks during a trial

About MedidataMedidata Solutions is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud™ brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.

[email protected] | mdsol.com+1 866 515 6044

SummaryMedidata RBM provides the fastest course to effective risk-based monitoring through:

• Statistical analytics that turns on in days t.

• Real-time analytics driven targeted monitoring

• Industry benchmarks that allow customers to compare their performance to industry peers.

Medidata Clinical Cloud™

Cloud-based clinical research solutions | Innovative technology | Data-driven analytics Reduced costs | Improved time to market | Faster decisions | Minimized risk

medidata rbm risk-based monitoring in the clinical cloud

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