The document discusses overcoming barriers to risk-based monitoring. It identifies five common barriers: the need to verify every source document; lack of staffing and equipment for centralized monitoring; risk-based monitoring introduces too much risk; risk-based monitoring is too expensive; and that studies are unique and risk-based monitoring is not appropriate for all. It then proceeds to address each of these barriers, arguing that the right technology-supported processes and experienced teams can implement centralized risk-based monitoring, that it focuses on relevant data to reduce risk rather than increase it, and that it can potentially reduce monitoring costs by 20% for large phase III trials.

1. © 2014 BioClinica, Inc. – Proprietary and Confidential
Overcoming Barriers
to Risk-Based Monitoring

2. 2© 2015 BioClinica, Inc. – Proprietary and Confidential© 2015 BioClinica, Inc. – Proprietary and Confidential
BARRIERS
There are 5common
To Risk-Based Monitoring

3. 3© 2015 BioClinica, Inc. – Proprietary and Confidential 33© 2015 BioClinica, Inc. – Proprietary and Confidential
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?

4. 4© 2015 BioClinica, Inc. – Proprietary and Confidential 44© 2015 BioClinica, Inc. – Proprietary and Confidential
BREAK THROUGH
THE BARRIERS!
RISK-BASED
MONITORING CAN
BE A REALITY!

5. 5© 2015 BioClinica, Inc. – Proprietary and Confidential 55© 2015 BioClinica, Inc. – Proprietary and Confidential
Risk-Based Monitoring Introduces
too Much RISK

6. 6© 2015 BioClinica, Inc. – Proprietary and Confidential 66© 2015 BioClinica, Inc. – Proprietary and Confidential
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!

7. 7© 2015 BioClinica, Inc. – Proprietary and Confidential 77© 2015 BioClinica, Inc. – Proprietary and Confidential
Studies are Unique and RBM isn’t Appropriate for All

8. 8© 2015 BioClinica, Inc. – Proprietary and Confidential 88© 2015 BioClinica, Inc. – Proprietary and Confidential
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

9. 9© 2015 BioClinica, Inc. – Proprietary and Confidential 99© 2015 BioClinica, Inc. – Proprietary and Confidential
Every Source Document MUST be Verified

10. 10© 2015 BioClinica, Inc. – Proprietary and Confidential 1010© 2015 BioClinica, Inc. – Proprietary and Confidential
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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13

14. 14© 2015 BioClinica, Inc. – Proprietary and Confidential 1414© 2015 BioClinica, Inc. – Proprietary and Confidential
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. 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
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