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4Site - Overview of clinical study oversight tool.

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How 4Site can help your
organisation
15 September 2018
Need support with your oversight?
After database lock, all interest lies in the analysis of (hopefully) accurate
data. Yet it's often during the study conduct phase that the data is invariably
at its most critical stage - without effective oversight or grasp where the
issues are, the study outcome is at an increased risk level.
Authorities are increasingly emphasizing the need for sponsors to
demonstrate effective oversight of clinical studies (e.g. ICH GCP E6 (R2)).
Therefore data needs to be explored through different methods and via
different angles. Having data review plans is very well, but where is the proof
that oversight occurred?
4Site ‘workings’
4Site enables you to sort
out your apples from
your oranges and
present your data in one
simple unified oversight
and reporting tool.
Std visualisations and
presentation
Std report generation
Typical scenario
We envisage a number of scenarios whereby 4Site could help in your organisation..
After database lock, all interest lies in the analysis of
(hopefully) accurate data. Yet it's often during the study
Too
manyphase
disparate
Typically,
conduct
thatreporting
the datasystems:
is invariably
at itsstudies
most
have been supported by a number of systems and because
critical
stage
- without
effective
oversight
or grasp
where
No
internal
programming
resource:
internal
of the
disparate
methodologies
inLimited
system
setup,programming
there is
the issues
theorganisation
study outcome
is atand
an
increased
risk
resource
has
left
with
systems
that
areproven
only semiconfusion
atare,
thethe
user-level,
lower
uptake
has
4Site
has
been
programmed
to
'plug
into'
various
Mulitiple
Too
many
reporting
disparate
platform
reporting
failures
systems
Multiple
EDC/paper
systems
level.
usable,
again
resulting in lower
little information
difficult
at
management
level uptake,
to pieceand
together
useful of use
Budget
restrictions
No
internal
programming
resource
systems
using
raw
database
extracts
that
feed
intoand
theis
for
effective
management
of studies and oversight.
Once
information
acrossAn
theorganisation/department
portfolio.(4Site
is user-friendly
Budget
restrictions:
may
have4Site
implemented,
'Std
Data
Engine'.
there
isto
This
noadopt
further
enables
programming
all users
to
benefit
unless
from
thea
able
to provide
information
at
study-level
uprequired,
to
portfolio
level)
invested
significantly
EDC
add-ons
that
are
typically
lauded
as the
holy
grail to
of be
analytical
systems
with
little all
proven
client
requires
add-ons
implemented
or changes
are
required
standard
user
interface
that
is identical
across
studies
benefit
and
are
now
very
risk-averse
in
trying
out
another
system.
due
protocol
changes
that impact the design of the study)
rightto4Site,
up
towe
portfolio
level
With
are confident
in its application and are willing to
discuss a low-entry cost model.
The above points often lead to your study
ending up in a black hole. 4Site is able to shed
light on your study.
Imagine….
4Site overview
…. a tool that is capable of the following:
•
Data input from multiple EDC platforms (no need to duplicate!)
•
•
•
Other data sources possible (e.g. IWRS/IVRS)
Provides you with study metrics/KPIs (query ageing, visit logging, data backlogs…)
Allows forecasting of future planned visits or effect of a data-cut date (e.g. how many visits
are going to occur in the next 6 weeks or up to certain cut-date)
•
Granular data browsing (regional, country, site, patient level)
•
Visualisations
•
Customisable to include more than 200 KPIs, 50,000 patients
•
Data export/findings into PDF or Excel
•
Pre-drafted monitoring or study team reports
•
Record and retain reviewer comments for future reference (no need to re-enter comments on
every review!)
….and much more…..
How can 4Site help?
•
Shed light on black holes: 4Site is able to plug those black-holes where user interaction
is low and the much needed study information flow is erratic or very resource-intensive.
4Site allows for fast user-adoption as the tool has been carefully programmed with a
multi-faceted cross-functional approach.
•
Finding needles in haystacks: 4Site allows users to visualise and de-clutter finding
needles in often 'hay-stacked' data without the need for additional programmed
extracts. Study statuses and 'what-if' snapshots are easily generated using near-time
data - these can all be compiled into reports.
•
How can 4Site sit alongside existing strategies/existing platforms? It’s been developed
to work with any clinical trial database (EDC or paper-based). 4Site itself is not an EDC! It
sits alongside an EDC to extrapolate critical datapoints that allow the system to build
various 'modules' such as metrics, cleaning status (i.e. data issues), tracking capabilities
(e.g. PK, central lab), specialist review tools (e.g. RECIST), and internal
resourcing/planning.
How can 4Site help?
•
Co-existence with other platforms: As part of the review/cleaning strategy, data review
plans will dictate how the data is being handled with a variety of programmed edit
checks (which may run into the thousands) and manual review listings. Furthermore
there may be additional supportive platforms that help analyse the data (e.g. Tableau,
Spotfire, J-review etc). 4Site can co-exist with these systems and capture studies that
can’t be fully supported.
•
Standardised reporting with multiple vendor/ EDC systems: Your organisation may have
multiple EDC platforms and support from multiple outsourced vendors (CROs) - 4Site
can bring together a standardised reporting structure for high level comparison of study
status and data issues across the board using 1 tool.
•
Catching the worm before the early bird: Often, a company may have multiple studies
that are outsourced to numerous vendors that adhere to the client's standards.
Typically, it’s only when database lock encroaches that it is apparent that the vendors
have had a different interpretation of the standards. It's only then that serious data
issues come to light.
How can 4Site help?
•
4Site - if adopted on all studies - permits for a standardised method for staff to track
study statuses and performance issues across the board and also allows for teams to
utilise standardised exported reports (rather than trying to understand multiple reports
from multiple vendors)
•
4Site allows for various specialist sub-tools/modules to be developed if needed by the
client. These can be merged into the 4Site tool, and include:
–
RECISTeX (In the pipeline): Tumour Response monitoring tool. Within oncology one of the primary
endpoints is Tumor Response where the endpoint is derived from multiple and repeated evaluations of the
tumor measurements across the study period. Often the way the data is collected and the way it is
structured within the database (a mix of information pulled from different panels/forms, study periods and
derived (calculated) variables) makes for an ineffective and inaccurate review. 4Site can aid in this area with
visualisations to show the reviewer the response evaluation and tumor size over time and highlight those
areas that may need to be queried or alerted to the medical reviewer.
– LabTrEx: Sample Tracking & EDC/Lab reconciliation (Under-development)
– Anything else?
Need a hand to compare your
apples from your oranges?
apples-and-oranges.co.uk
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