1
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 onsite 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 and other marks used herein are trademarks of Medidata Solutions, Inc.
All other trademarks are the property of their respective owners.
Copyright © 2015 Medidata Solutions, Inc.
Medidata
empowers
biopharmaceutical
companies and
CROs to plan,
execute, analyze
and adjust their
studies using
a closed-loop
adaptive process.
07/2015 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 Benefit
Medidata 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 sitespecific 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 studylevel risk analytics,
site quality and
operational
analytics that
identify variations
on data quality
at a site, protocol
compliance and
subject retention.
2
07/2015 FACT SHEET
MEDIDATA RBM: THE FASTEST WAY TO REALIZE THE QUALITY, COST AND
TIMELINE BENEFITS OF RISK-BASED MONITORING
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).
Figure 2: Study- and site-level dashboard views enables real-time monitoring of KRIs
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).
Figure 3: How Medidata RBM helps rapidly reduce monitoring costs
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.
3
07/2015 FACT SHEET
MEDIDATA RBM: THE FASTEST WAY TO REALIZE THE QUALITY, COST AND
TIMELINE BENEFITS OF RISK-BASED MONITORING
Seamless Interoperability
Medidata 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).
Figure 4: Real-time monitoring of risk help improves data quality
Achieve Deep and Sustainable Value
Powerful 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.
4
Powerful algorithms,
informatics
and business
intelligence provide
a set of machine,
self-learning
algorithms that
define and derive
risks based on
actual study data
07/2015 FACT SHEET
MEDIDATA RBM: THE FASTEST WAY TO REALIZE THE QUALITY, COST AND
TIMELINE BENEFITS OF RISK-BASED MONITORING
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:
5
Summary
Medidata RBM provides the
fastest course to effective riskbased monitoring through:
•S
tatistical analytics that turns
on in days t.
•R
eal-time analytics driven
targeted monitoring
• I ndustry benchmarks that allow
customers to compare their
performance to industry peers.
• 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).
Figure 5: Medidata RBM helps identify known and unknown risks during a trial
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.
Medidata Clinical Cloud™
Cloud-based clinical research solutions | Innovative technology | Data-driven analytics
Reduced costs | Improved time to market | Faster decisions | Minimized risk
About Medidata
Medidata 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