- Industry drivers for change and benefits of eRegulatory - Tips for choosing the right system and evaluating a vendor - Best practices and mistakes to avoid when going electronic

1. Best Practices for Managing
Regulatory Binders Electronically
Trisha Locke, CEO at Keystone Research
Bree Burks, VP of Strategy, Site Solutions at Veeva

2. Speakers
Bree Burks, RN, MSN
VP of Strategy, Site Solutions
Veeva Systems
Trisha Locke
CEO
Keystone Research

3. Today’s Agenda
Industry drivers for change and benefits of eRegulatory
1
Tips for choosing the right system and evaluating a vendor
2
Best practices and mistakes to avoid when going electronic
3
Q&A
4

4. Industry drivers for change
and benefits of eRegulatory

5. How are sites currently storing
and managing regulatory documents?
• Paper
• Shared drive / SharePoint / Flash drives
• eRegulatory / eISF system
• Sponsor portal / SIP
• Other
• Not a site / Not applicable

6. Landscape is changing
• More trials
• Personalized medicine =
fewer patients per study
• Technology complexity
2000 2004 20192008 2012 2016
# of Trials
0
300,000
250,000
200,000
150,000
100,000
50,000
# of Trials Linear (# of Trials)
ClinicalTrials.gov, 2019

7. Software Challenges
SCRS
44%
51%
63%
74%
90%Too many systems
Repetitive training
Require redundant data entry
Distract from patient care
Insufficient tech support
SCRS and Oracle Impact Assessment of eClinical Technology and Industry Initiatives on Sites, 2019

8. Software Challenges
Oracle & SCRS, 2019
57%32%
6%
5%
Somewhat well Not very well Not well at all Very well
Do software applications meet site’s needs?

9. Access to Information
Collecting signatures
Training and staff changes
Monitor visits
Standardization
Compliance
Storage space
Finding new treatments
Activating Studies
Recruiting patients
Patient care
Paper and Hybrid Systems Create Bottlenecks
Bottleneck

10. 2009
EHR stimulus passed
(12% EHR adoption)
2015
96% EHR adoption
Medicare Access
and CHIP
Reauthorization
Act (MACRA)
2018
FDA requires all
eCTD
submissions
from sponsors
to be electronic
2016
21st Century
Cures Act
Cancer
Moonshot 2020
2018
ICH GCP
guidelines
updated to
account for
electronic
records
2019
Scott Gottlieb
encourages
adoption of
technologies to
make research
more effective
Industry Drivers for Change

11. Remote
Monitoring
Dashboards &
Analytics
Staff
Profiles
21 CFR Part 11
and HIPAA
Compliance eRegulatory
(eISF)
Standard
Naming & Filing
Workflows &
eSignatures

12. Remote Monitoring
• Regulatory and source documents
• Training and delegation of authority
(review before SIV)
• Audit trails showing all monitor activity
• Providing access vs. facilitating workflow
• Reports showing documents added since
last visit
Work
collaboratively
Speed
study
Startup
Focus on
patients

13. Business Benefits
Reduce
Administrative Burden
Speed Study
Activation
Increase
Visibility
Manage Staff
Changes
Improve
Competency
Reduce Monitoring
Time & Costs

14. Tips for choosing the right
vendor and system

15. Archiving
Audit trails
Affordable
Validation support
Automation
Standard naming and filing
conventions for staff
Integration w/sponsors
Version control
Challenges with a
DIY Approach

16. What should sites consider before
contacting a vendor?
Current ecosystem
• Understand current processes and
systems in place
Staff buy-in
• Who else needs to be involved?
• Will staff support the use of the system?
• Who can lead the project?
• Is a clear decision making process in place?
Cost and budget
• Implementation and ongoing fees
• Building the cost into study budget
Goals (Focus on outcomes, not features)
• What tasks require the most time to complete?
• What compliance risks are we looking to avoid?
• What processes require duplicate data entry?
• What trackers or logs would we like to eliminate?
• What metrics are we looking to improve?
• What processes are we having trouble enforcing?

17. Nice-to-haves
 Perform work in the system
 Integration with sponsors/CROs
 Searching and version compare
 Reports and dashboards
 Version control
 Certified copy workflows
 Integrations
 Source monitoring and workflows
What to look for in a product?
Must-haves
 Price: No long term contracts or
sponsor budget negotiations
 Ease of use: Get up and running
quickly and drive adoption
 Not too much flexibility: Lock
down control to enforce standards
 Reporting: See what’s done and
what’s not

18. What did you look for in a vendor?
• Well-known and trusted in the industry
• Upgrades and speed in adding new functionality
• Ability to scale and support global performance
• Customer satisfaction
• Training and support
• Downtime support levels
• Contract terms
More Than Just
Software

19. Best practices for
implementation

20. Best practices for implementation
• Rip the Band-Aid off and get started
• Navigate new terminology
• Roadmap for populating information
• Update policies and SOPs
• Get stakeholder buy-in (end-users, PIs, leadership)
• Communicate with sponsors and monitors
• Be flexible with your processes
• Responsive support (online support and
documentation)

21. Thank you!
Bree Burks, RN, MSN
VP of Strategy, Site Solutions
Veeva Systems
Trisha Locke
CEO
Keystone Research