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Global clinical trial solutions. Real-world results. © 2014 BioClinica, Inc. – Proprietary and Confidential 3 REASONS Intelligent Monitoring OUTPERFORMS Risk-Based Monitoring

3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

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Page 1: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Global clinical trial solutions. Real-world results.

© 2014 BioClinica, Inc. – Proprietary and Confidential

3 REASONS Intelligent Monitoring

OUTPERFORMSRisk-Based Monitoring

Page 2: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Its Not Just About

Reducing

monitoring

visits!

Page 3: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Intelligent Monitoring IMPROVESthe Overall QUALITY of Clinical Trials

Page 4: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Intelligent Monitoring FOLLOWS a QUALITY MANAGEMENT MODEL

Page 5: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Its Not Just About

Technology!

Page 6: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Intelligent Monitoring Incorporates PEOPLE, PROCESS and TECHNOLOGYto Implement Risk-Based Monitoring

Page 7: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Change Management

Defined Workflow & Roles

Communication Plan

Technology Designed to Meet the Need

Page 8: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Its Not Just About

Quantitative Data!

Page 9: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Intelligent Monitoring combines DIFFERENT TYPES OF VARIABLES and looks at TRENDS over the course of a trial.

QUANTITATIVE

COMPASS Analytics

QUALITATIVE

Imaging

Labs

Others

EDC

CTMS

IRT

BP Risk Assessment

BP Monitor Survey

BP Site Survey

Page 10: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

Intelligent Monitoring is the

answer! Relevant Data

Meaningful Performance

Action Oriented

Adaptive based on actual performance

Page 11: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

TOOLS AND TECHNOLOGY

INTELLIGENT MONITORING

STRATEGY AND PLANNING

Page 12: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

The Compass INTELLIGENT MONITORING SOLUTIONfocuses on meaningful data, critical to the success of a trial, and makes it easy to view the overall performance of trial sites. It does the work of tracking trial performance and identifying performance issues across sites to ensure the most EFFICIENT AND EFFECTIVE USE OF RESOURCES.

Most studies include several thousand data points.

Have you wondered if you and your team are LOOKING AT THE RIGHT ONES?

Page 13: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

How Compass Works

Monitor what matters,

when it matters!

Integration of Disparate Data Sources

Lab

Trial DataAdmin Data

› Identify issues› Take action early› Increase compliance› Improve data quality› Save time and money

COMPASS®:data filter

COMPASS®: Proprietary

qualitative data

COMPASS®: algorithm

Page 14: 3 Reasons Intelligent Monitoring Outperforms Risk-Based Monitoring

VISIT www.BioClinica.com/Compass

READ our Intelligent Monitoring Blog Series

JOIN our Webinar An Intelligent Approach to Risk-Based Monitoring

Are you ready for

Intelligent

Risk-Based

Monitoring?