Complexity and

Complications. . .
How can we make clinical trials easier?
 Experience
Phase IV Phase I

300
Studies
Phase III Phase II

eSource Pioneer – 195 studies

Regulatory Acceptance

BYOD Pioneer – 55 studies 33 Regulatory submissions

9 Approvals

Acquired by $21B Investor

 Complex Complicated

Clinical Trials are ‘Complex’ and ‘Complicated’

 How to Simplify
“DDC” “BYOD”
• Protocol compliance • Increased Compliance
• Real-time data • Reduced Cost (>20%)
• EDC/eCOA/ePRO all-in-one • Eliminates Inventory
• “True” remote monitoring • Simple for Sites/Patients
 Simplify Implementation
BYOD optimized forms Build time: <30 days
Tablet, Phone, Web Options Licensing, Translations, Data Mappings
 How to Simplify
“Virtual” “Hybrid”

• PATIENT participates from home • PATIENT has on-site / at-home options

• No physical site; remote interactions • Reduce ‘inconvenience’ factor
• Business Model change • May require multiple systems
 Hybrid Patient Journey

Sponsor-Defined On-Site / At-Home Options

 Platform
Innovation
allows
patients to
participate
the way
THEY want
 Patient-Defined Journey
n s Dyn
pt io am
O ic

apt able Flex

Ad i ble

Patients choose how to participate

 Good-Better-Best
Platform choice enables flexibility/adaptation

GOOD: BYOD ePRO

BETTER: Hybrid studies on a single platform

BEST: Patient-defined participation

“Nature is pleased with simplicity.
And nature is no dummy.”
Isaac Newton