More Related Content Similar to Overcoming Barriers to Risk-Based Monitoring (20) Overcoming Barriers to Risk-Based Monitoring1. © 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
12. 12© 2015 BioClinica, Inc. – Proprietary and Confidential 1212© 2015 BioClinica, Inc. – Proprietary and Confidential 12
The Right Technology-Supported Processes will Make it a Reality
Your Team Has the Experience to Perform Central Monitoring
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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Mireille Zerola
Clinical Data Management Expert at Boehringer
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Risk-Based Monitoring Workstream
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