An introduction to expediting Phases II, III and IV of the clinical trials feasibility and patient recruitment through the better use of data

1. Confidential and in confidence
Customer Briefing
30th April 2014
Peter Watts
THIS DOCUMENT AND THE INFORMATION AND DATA IN IT ARE PRIVILEDGED AND CONFIDENTIAL.
THEY ARE PROVIDED IN CONFIDENCE, FOR THE SOLE PURPOSE OF EVALUATING THE CLINICAL CUBE
OFFER AND MAY NOT BE DISCLOSED TO ANY THIRD PARTY OR USED FOR ANY OTHER PURPOSE
WITHOUT THE EXPRESS WRITTEN PERMISSION OF THE CEO OF CLINICAL CUBE LIMITED.

2. Confidential and in confidence
Clinical
Cube
deploys
data
and
technology
that
expedites
and
transforms
the
five
stages
of
clinical
trials
and
related
drug
development
processes.
Our
solu;on
allows
us
to
process
and
dis;ll
massive
amounts
of
standard
and
non-­‐standard
observa;onal
and
clinical
data.
Proprietary
data
extrac;on
capabili;es
allow
us
to
turn
data
into
knowledge,
deliver
focused
reports
and
run
unique
pa;ent
recruitment
and
monitoring
processes
on
behalf
of
our
clients.
Proposi;on

3. Confidential and in confidence
Current
prac;ce
Random
Clinical
Cube
Precise
• Clinical
Cube
replaces
current
fragmented
&
inefficient
processes
with
an
ultra
efficient
data
&
technology
solu;on
• Our
managed
service
provides
immediacy
and
accuracy,
removing
the
arbitrary
nature
of
manual
legacy
clinical
data
collec;on
solu;ons
Unique
Proposi;on

4. Confidential and in confidence
• CC//DATA
is
the
central
data
warehouse
that
drives
all
of
Clinical
Cube’s
individual
product
solu;ons.
• Real
world
health
and
demographic
data
combines
with
primary
and
secondary
care
health
data
sources
to
build
the
core
of
Clinical
Cube’s
analy;cal
services
CC//DATA
CC//DATA
CC//
Feasibility
CC//
RECRUITMENT
CC//
REPORTER
Clinical Cube
Product portfolio

5. Confidential and in confidence
All
repor;ng
and
analysis
is
developed
in
collabora;on
with
our
customers
and
the
outputs
are
unique
in
regard
to
their
specific
needs.
Typically
these
reports
include
the
following:
Report
and
analysis
• Prevalence
by
geography
-­‐
produced
na;onally,
regionally
and
by
surgery.
• Prevalence
by
hospital
–
surgeries
linked
to
hospital
by
radius
• Disease
incidence
by
hospital
• Loca;on
–
geographical
analysis
of
trials
by
loca;on
showing
phase
of
trial,
therapeu;c
area,
recruitment
target
and
recruitment
status
Feasibility
• Na;onal
prevalence
review
and
locality
hotspot
iden;fica;on
• Aggregated
(non
PCD)
subject
data
extracted
from
GP
systems*
• Individual
subject
data
(PCD)
extracted
from
GP
systems
*
Recruitment
• Aggregated
(non
PCD)
subject
data
extracted
from
GP
systems,
weekly,
monthly
quarterly
*
• Individual
subject
data
(PCD)
extracted
from
GP
systems
*
• Safety
and
surveillance
reports
*
• Excep;on
and
adverse
events
repor;ng
*
• Quality
of
life
reports
*
Reporter
• Clinical Cube, under IGSoC governance standards, will support appropriation
of data extraction agreements with GP’s, Investigators and patients

6. Confidential and in confidence
• The
impera;ve
to
be
agile
and
accurate
in
delivering
trial
feasibility,
at
all
phases
of
development,
has
never
been
greater.
Speed
and
precision,
combined,
offer
the
key
to
expedi;ng
drug
development
;mescales
and
improving
related
ROI.
• CC//Feasibility
is
used
to
address
feasibility
analysis
at
the
outset
of
trial
development,
Phase
0,
and
throughout
phases
II,
III
and
IV
of
the
trial
development
process.
• Combining
UK
observa;onal
health
data
with
other
related
informa;on
sets
allows
our
systems
and
analysts
to
work
hand-­‐in-­‐hand
with
our
customers
to
be_er
inform
and
accelerate
the
feasibility
and
assessment
stages
of
all
phases
of
the
drug
development
process.
CC/FEASIBILITY

7. Confidential and in confidence
CC/FEASIBILITY
• CC/Feasibility
uses
the
latest
Geo-­‐mapping
tools
to
iden;fy
pa;ent
cohorts
across
the
country
using
the
trial
protocol
to
define
the
search
algorithm
• Once
na;onal
pa_erns
have
been
iden;fied
data
can
be
interrogated
at
a
local
surgery
surgery
level
Confidential and in confidence

8. Confidential and in confidence
• Pa;ent
recruitment
remains
one
of
the
most
challenging,
;me
consuming
and
costly
aspects
of
any
trial.
Without
high
quality
search
and
selec;on
at
the
beginning
of
a
project,
the
results
can
ocen
lead
to
poor
reten;on,
project
delays
and
at
worst
trial
failures.
• Working
within
stringent
and
approved
data
governance
prac;ces,
CC//
Recruitment
u;lises
CC//Data
to
deliver
a
3
step
process
that
allows
a
trial
organisa;on
to
iden;fy
likely
pa;ent
groups,
provide
access
to
pa;ents
with
the
support
of
their
GP
and
finally
provide
onward
pa;ent
contact
management.
• Using
our
unique
data
driven
approach,
CC//Recruitment
removes
the
arbitrary
nature
of
clinical
trial
pa;ent
enrollment.
Our
collabora;ve
approach
combines
the
interests
of
the
trial
organisa;on,
inves;gator
site
and
pa;ent
to
bring
a
new
level
of
proficiency
to
the
development
and
delivery
of
clinical
trials.
CC//RECRUITMENT

9. Confidential and in confidence
• Iden;fy
simple
and
complex
pa;ent
types
using
mul;ple
indicators.
Accurate
selec;on
ensures
faster
recruitment
and
lower
fall
out
rates
• Conduct
what-­‐if
analysis
to
build
around
centres
of
excellence
• Focus
CRA
ac;vity
• Lower
trial
failure
rate
• Reduce
costs
• Focused
results
CC//RECRUITMENT

10. Confidential and in confidence
• Access
to
data
to
support
observa;onal,
registry
and
health
outcomes
is
of
immense
importance
to
achieve
a
robust
and
high
quality
outcome.
Direct
access
to
real
world
data
presents
poten;ally
significant
;me
and
cost
savings
compared
to
the
more
tradi;onal
routes
of
achieving
data
collec;on.
• U;lising
granular
level
data,
including
quality
of
life
results,
enables
us
to
support
the
requirement
to
provide
ongoing
assessment
and
analysis
of
cri;cal
success
factors,
support
evalua;on
of
benefit-­‐risk
data
as
well
as
deliver
the
post
marke;ng
safety
surveillance
remit
required
by
regulators.
• Data
immediacy
is
central
to
our
solu;on.
CC//Repor;ng
ensures
that
our
customers
have
speed
of
access
and
a
degree
of
data
transparency
that
will
allow
them
to
transform
their
own
repor;ng
capabili;es.
Improving
quality
and
improving
outcomes.
CC//REPORTING

11. Confidential and in confidence
• Na;onal
pa;ent
cohorts
can
be
recognised
and
analysed.
• Each
group
or
individual
can
be
managed
and
analysed
on
an
ongoing
basis.
• Surveillance,
excep;on
repor;ng
and
QOL
can
be
monitored
on
an
ongoing
basis
CC//REPORTING

12. Confidential and in confidence
Thank You
Peter Watts
e. peter.watts@clinical.cube.com
t. 07776 131954
THIS DOCUMENT AND THE INFORMATION AND DATA IN IT ARE PRIVILEDGED AND CONFIDENTIAL.
THEY ARE PROVIDED IN CONFIDENCE, FOR THE SOLE PURPOSE OF EVALUATING THE CLINICAL CUBE
OFFER AND MAY NOT BE DISCLOSED TO ANY THIRD PARTY OR USED FOR ANY OTHER PURPOSE
WITHOUT THE EXPRESS WRITTEN PERMISSION OF THE CEO OF CLINICAL CUBE LIMITED.