© 2014 BioClinica, Inc. – Proprietary and Confidential

Overcoming Barriers

to Risk-Based Monitoring

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BARRIERS

There are 5 common

To Risk-Based Monitoring

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Every Source Document MUST be Verified

We Aren’t Staffed or Equipped for Centralized Monitoring

Risk-Based Monitoring Introduces too Much RISK

It is Too Expensive!

Studies are Unique and RBM isn’t Appropriate for All

Are you going to let them stop you?

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BREAK THROUGH

THE BARRIERS!

RISK-BASED

MONITORING CAN

BE A REALITY!

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Risk-Based Monitoring Introduces too Much RISK

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Risk-Based Monitoring is Designed to

monitor risks unique to a

trial

FOCUS ON:Relevant Data

&Meaningful

Performance

RBM DOES NOT Introduce RISK—it Reduces Risk!

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Studies are Unique and RBM isn’t Appropriate for All

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BUT…Your plan should be unique to each study :

• Based on risk assessment of protocol and sites• Not always reduction in visits • Smarter use of data for PROACTIVE

management

RBM Can Improve the Quality of EVERY Study

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Every Source Document MUST be Verified

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Risk-Based Monitoring Focuses Attention on RELEVANT data

Focus Your Attention to Reveal More Detail

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The Right Technology-Supported Processes will Make it a Reality

Your Team Has the Experience to Perform Central Monitoring

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RBM Technology Can Reduce Monitoring Cost by 20%

A Phase III trial will cost >$235 Million

$70 Million goes toward monitoring

Risk-Based Monitoring

could cut the cost by

$14 Million

15© 2015 BioClinica, Inc. – Proprietary and Confidential

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Courtney McBean

Vice President, Clinical Innovation

BioClinica

Mireille Zerola

Clinical Data Management Expert at Boehringer

Ingelheim and a member of the Transcelerate

Risk-Based Monitoring Workstream

Our Distinguished Speakers