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PAPER VS EDC: BENEFITS, CHALLENGES AND BEST

PRACTICES

Written by AJ Wilson, Business Development at Clinovo

2© 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?

3© 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

4© 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

5© 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

6© 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