’90 | ’91 | ‘92 | ‘93 | ‘94 | ‘95 | ‘96 | ‘97 | ‘98 | ‘99 | ‘00 | ‘01 | ‘02 | ‘03 | ’04 | ‘05 | ‘06 | ‘07 | ‘08 | ‘09 | ‘10 | ‘11 | ‘12 | ‘13
CONSTRUCTION
SOFTWARE PROGRAMMER
Y PRIME
BUSINESS FOUNDATIONSShawn started his career in business
founding a construction company in the
early 1990s.
CAREER CHANGEAfter over 10 years in the construction
business Shawn changed career paths
and became a database programmer
in the financial services industry. DEVELOPMENT & CONSULTINGSince 2000 Shawn has continued to advance in the
career of software development and software consulting.
LEADING GROWTHSince 2006 Shawn has lead the growth of Y Prime to
become a premier company with products and services
that support many top 50 Pharma companies.
SHAWN BLACKBURN – CEO Y PRIME
PHASE
I
CLINICAL TRIAL PROCESS
PHASE
II
PHASE
III
PHASE
IV
Determine the metabolic
and pharmacological
actions & the maximally
tolerated dose
Evaluateeffectiveness, determine
short-term side effects &
identify common risks for a
specific population and
disease
Obtain additional info
about the effectiveness on
clinical outcomes &
evaluate the overall risk-
benefit ratio in a
demographically diverse
sample
Monitor ongoing safety in
large population & identify
additional uses of the agent
that might be approved by
the FDA
1-888-201-7988 @y_primewww.y-prime.com [email protected]
Researchers
Finance Managers
Statisticians
Physicians
Surgeons
Pharmacists
Nurses
Study Coordinators
Administrators
Data Analysts
Lawyers
Scientists
Information Technology
Patients
{ Many disciplines are involved in the process }
HUMAN ELEMENTS OF CLINICAL TRIALS
MULTIPLE SOFTWARE SYSTEMS
Clinical research professionals operate within a controlled
industry requiring continual monitoring of many regulations
• Protocols
• SOPs
• Work Instructions
• Training
All in addition to actually doing their day jobs…
Working with Patients
HIGHLY REGULATED DATA
OUR CHALLENGE
SOFTWARE LIVEWARE UXHARDWARE
