1. Drug discovery
Pre-clinical studies
(Favorable results)
Clinical
trial life
cycle
Protocol, Investigator
brochure
development
IND submission - Study tools,
organization, and
management plan
development
Study start-up
- Site selections,
Regulatory/IRB approval,
site activation
- Study tools/database
set-up
- Subject enrolment, IP
administration
- Data recording &
reporting
Study conduct
- Monitoring
- Data review &
management- Pending data
discrepancy resolution
- Return or destruction of
IP & study tools
Study close-out
- Data analysis
- Study report
NDA submission
and approval
Scientific
publications
Post-marketing
research (long-
term) and evaluation
