The document discusses improving study efficiency through modern electronic data capture (EDC) from a contract research organization (CRO) perspective. It highlights the roles of various stakeholders in clinical research and the integration of design specifications, protocol amendments, and user experience in study management using Veeva Vault EDC. The content also notes a focus on modifying study protocols and enhancing data management practices.

2. Improving Study Efficiency
with a Modern EDC
A CRO Perspective

3. 3
Copyright © Veeva Systems 2019
Speakers
Dan Crawford
Senior Director, Vault CDMS
Veeva Systems
Harbal Sidhu
Senior Manager, Data Mgmt.
ICON plc
Tanya du Plessis
Vice President, Data Strategies
Bioforum
Jennifer Nezzer
Director, Biometrics
Lotus Clinical Research
Andrea Krueger
Clinical Data Manager
Lotus Clinical Research

4. 4
Copyright © Veeva Systems 2019
Fusing Specification & Design

5. 5
Copyright © Veeva Systems 2019
Protocol
Standards
Therapeutic area
/ study-specific
specs
Casebook
Edit checks
Rules
Comprehensive,
system-generated
study specifications
Data Manager
Fusing Specification & Design

6. 6
Copyright © Veeva Systems 2019
Building Studies with Veeva Vault EDC
• Studio design interface
• Edit checks
• Dynamic forms and event groups
• Rules engine

7. 7
Copyright © Veeva Systems 2019
Protocol Amendments
• Updating eCRFs and rules
• Deploying updates
• Impact on sites
• Study Differences Report

8. 8
Copyright © Veeva Systems 2019
User Experience
• Site personnel
• Clinical Research Associates
• Data Managers
• Sponsors

9. 9
Copyright © Veeva Systems 2019
• Site personnel
• Clinical Research Associates
• Data Managers
• Sponsors
User Experience

10. 10
Copyright © Veeva Systems 2019
Questions & Discussion

11. 11
Copyright © Veeva Systems 2019
Closing Remarks

12. Thank you