Today, more than 50% of regulated studies are still run on paper. This number rises to about 80% if we include non-regulated studies (i.e. Nutraceuticals, cosmetics, skin treatments, etc.). In this technologically driven age, it seems that the number of trials conducted on paper would be dramatically lower.

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PAPER VS EDC:
BENEFITS, CHALLENGES AND BEST PRACTICES
Written by
AJ Wilson, Business Development at Clinovo

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© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Introduction
 More than 50% of regulated studies still run on paper
 More than 80% if we include non-regulated studies
 What are the hurdles still preventing these numbers to decrease?
 What are the overall benefits of Electronic Data Capture?

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© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Barriers to Entry of EDC
 High Upfront Costs
 Long database setup and design (5-8 weeks)
 License fees and/or monthly charges
 Programmers sourcing can represent high expenses
 Lack of Technical Knowledge
 Disrupted workflow for paper-based users
 Need to adapt to new features (In system-
randomization, medical coding, etc.)
 Training and certification of the staff
 Resistance to Change
 Hard to change structural processes
 Lack of reliable internet network

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© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Benefits of EDC
 Data Quality
 Real-time access to centralized data
 Discrepancies and safety issues are captured and
resolved much earlier
 The entire clinical workflow is sped up
 Source Data Verification
 Time Reduction
 Captured data is exchanged electronically between sites
and sponsors
 No secondary data entry
 Reduced or eliminated number of on-site monitoring visits
 Long-Term Cost Effectiveness
 Reduced budget allocated to on-site monitoring visits
 No CRF printing or shipping costs
 Query management budget reduced by 80% on average

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© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Future of Data Collection
 Simplified Systems for In-House Control
 Less and less programming needed
 Empowering sponsors to have full control
 No more license fees
 Central Systems
 Open API’s communicating with other systems
 Simplified imported and exported data
 Cloud Based EDC Systems
 On-demand, self-service model
 Flexible cost structure (Pay only for what you use)
 Great way of dealing with exponential data

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© 2014 Clinovo. All Rights Reserved.
The contents of this document are confidential and proprietary to Clinovo
Future of data collection
 Integrated ePRO Systems
 Placing the patient at the epicenter of clinical research
 Systems focused on ease of use and user experience
 Faster data capture and simplified workflow
 Quicker response time in case of adverse events