CASE STUDY

1

Nordic Bioscience Targets 20 Percent
SDV with Risk-Based Monitoring toStreamline Clinical Trial Execution

Risk-BasedMonitoring
Implementation

The Challenge• Informed consent

Recently, Nordic Bioscience, one of the fastest-growing biotech companies in Europe,
realized that it was outgrowing its homegrown electronic data capture (EDC) system. Thecompany determined that maintaining its in-house EDC system would require significant
resources that would be better spent serving its mission of being the reliable partner ofdoctors and pharmacists. Adopting an external EDC solution would enable it to focus its
resources on bringing innovative drugs to market.
Nordic was already a pioneer in utilizing reduced source document verification (SDV),
routinely applying 50 percent SDV in most of its clinical trials. However, Nordic’s teams
were burdened by a highly manual process: once subjects were classified as requiring SDV,
records were color-coded in spreadsheets that monitors used to manually guide who andwhat data to verify. In addition, Nordic faced a bigger challenge of ensuring that the monitors
executed SDV according to the plan. This burdensome manual process did not support
Nordic’s aspirations to capitalize on recent regulatory guidance in risk-based monitoring.
Moving from reduced monitoring to true risk-based monitoring could enable Nordic tofurther reduce its SDV to 15–20 percent, which could yield significant cost savings while
increasing data quality in compliance with FDA’s new guidelines on risk-based monitoring.

The Solution
Nordic chose Medidata Rave EDC as the best EDC solution to achieve its goals. While
exploring Rave EDC, Nordic identified that it could also benefit from Medidata Rave TSDV
(Targeted Source Data Verification) solution to streamline its reduced SDV process andenable a true risk-based site monitoring process. Nordic chose Rave TSDV for its ability
to:• Execute an auditable and compliant targeted SDV strategy;• Set up and track targeted SDV within the Rave EDC system; and• Support different targeted SDV models for individual studies and sites.
With no process change required, Nordic smoothly implemented Rave TSDV tosupplement its manual practices. The initial success in streamlining reduced SDVprocess propelled Nordic to move toward true risk-based monitoring with the goal offurther reducing SDV to the 15–20 percent range.

Business Impact
Nordic adopted Rave TSDV to streamline reduced SDV in a global study – overMedidata and other marks used herein are trademarks of Medidata Solutions, Inc.
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Copyright © 2019 Medidata Solutions, Inc.

In piloting risk-based monitoring,
Nordic identified critical data points
that require 100 percent SDV:
• Inclusion/Exclusion criteria• Adverse and serious adverse events• Drug accountability• Safety• Primary endpoints• Efficacy
For other data points, centralized
monitoring strategy is employed toidentify emerging risks, track key
performance indicators (KPIs) andguide SDV level.

CASE STUDYNORDIC BIOSCIENCE TARGETS 20 PERCENT SDV WITH RISK-BASEDMONITORING TO STREAMLINE CLINICAL TRIAL EXECUTION

40 sites spanning Eastern Europe, Asia, Latin America and the United States. Within thatstudy, Nordic piloted a risk-based monitoring approach in Denmark, using a centralized
monitoring strategy that identified emerging trends and potential high-risk areas.
Powered by the power of Rave TSDV, Nordic could easily make real-time adjustments toSDV requirements, prospectively or retrospectively, at the geography, site or subject level.
With positive pilot experience, Nordic has great hopes for its risk-based monitoring:• Streamlined SDV Execution, Tracking and Reporting“Within one week of having Rave TSDV up and running, we immediately saw thebenefits of replacing spreadsheets in our monitoring practices. With that alone, it’salready a big success,” said Jeppe Ragnar Andersen, head of clinical development atNordic. Eliminating the manual comparison, tracking and reporting in SDV execution
not only improved efficiency of both data managers and monitors, but also eliminatedthe human errors inherent in manual processes.
• Reduced Monitoring Costs with Risk-based Practice
Nordic expects to further reduce its SDV coverage from today’s 50 percent to its targetof 15–20 percent by fully leveraging risk-based SDV. This has potential to realize
millions of dollars in cost savings per study. Nordic can now dynamically adjust SDV
requirements mid-study based on identified risks – the heart of risk-based monitoring– which was nearly impossible in its previous spreadsheet-based practices.
• Improved Data Quality
Nordic also expects to improve data quality with risk-based monitoring enabled by
Rave TSDV. “If you focus on everything, you don’t focus on anything. Monitors want tolook at what matters,” said Andersen. Monitors can concentrate on the data elements
truly critical to the overall quality of the study. In addition, sparing monitors from timeconsuming SDV activities allows them to engage in more value-added
on-site activities, such as protocol training. By proactively addressing high-risk areas,
Nordic can eliminate potential quality issues well before they happen, improving theoverall quality of the study.

The Platform of Choice for Clinical Research
The Medidata Rave Clinical Cloud is the cutting-edge platform that transforms theclinical trial experience for patients, sponsors, CROs, and research sites. Designed witha unified data platform, the Rave Clinical Cloud creates a single source of truth for all
study-related data. Simply put, enter data once and let the platform master andpopulate it throughout the end-to-end suite of Rave applications. Optimize operational
execution, decrease the data entry and maintenance burden, and reduce the number ofclinical systems across your study teams. Throw away your list of passwords, you are
now on a truly unified platform.

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

2About NordicBioscience
Nordic Bioscience ClinicalDevelopment (NBCD) seeks toachieve excellence and continuously
improve performance in clinical trials
leading to better drugs, faster to themarket and improved patient benefit
around the world. Our extensive
operational and scientific experiencein osteoporosis, osteoarthritis
and diabetes provides clients within-depth know-how and superior
management for all levels of theclinical trial process. With a strong
commitment to protect and improve
patient safety, NBCD works withhigh-enrolling, dedicated clinical
trial centers to deliver rapid andquality recruitment.

nordicbioscience.com

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