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The most ambitious, prolific and progressive software solution available
for Clinical Trails is a customized, complete, end-to-end, EDC / CTMS /
Randomization Plus application aptly named
Simplicity.
Developed by Software Dynamics, Simplicity was designed with in-
depth aid and input from ENLIGHTEN, INC. in order to become the
most all-inclusive, fully-comprehensive, highly-customizable application
of its kind anywhere in the world.
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With Simplicity, clinical trial management is made easy by integrating
dynamic composition, intuitive architecture, multi-layered security and
real-time reporting for convenience, convergence and compliance.
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The primary and unrivaled feature
of Simplicity’s architecture is the
flexibility it offers to all potential
users. Simply put, potential users
have the option of utilizing
Simplicity in the form of a client
server, computer-based application
OR in the form of an application
server, internet-based application.
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Additionally, the architecture that
supports Simplicity is packed with
cutting edge features that ensure
data loss is all but impossible and
thus, virtually a thing of the past.
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The basic layout includes dual
servers, each with Raid 10
redundancy, an off-site local
daily backup to a mass storage
server, and weekly off-site
media storage on digital
CD/DVD or Tape.
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If desired, an additional
secondary server housed in a
secure, remote location can also
be included with any system
configuration.
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Following initial password
authorization, Simplicity greets
each individual user with an Alerts
and Announcements page that
highlights any activity that might
require immediate attention.
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Categories include:
Email, Queries, Adverse Events,
Serious Adverse Events, Protocol
Deviations and PI Signature Files.
Additionally, Sponsors can
communicate with users on this
page through the announcement
box.
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Additionally, access to the live
network requires a user-unique
electronic signature accompanied
by a constantly changing encrypted
pass code. Such strict measures
secure Simplicity to the extent
equivalent to that of a virtually
impenetrable global internet
banking system.
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One of many user-friendly aspects
of Simplicity is a protocol-specific
schedule of assessments on each
and every page within Simplicity
accessible to all users.
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An example Schedule page from Simplicity.
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Unlike the formats of most other
EDC systems on the market today,
the Simplicity format for Case
Report Forms was designed to
emulate paper Case Report Forms
as demonstrated by this Screening
Visit page. Thus, making the
transition from paper or another
EDC system to Simplicity is easy
and intuitive.
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This design technique was fueled by
the understanding that all CRF
entries are divided into just two basic
categories:
Visits
and
Events
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Visits being the actual occurrence of
a subject’s on-site participation in a
clinical trial.
Events being anything that can
happen during such visits.
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An example Screening page from Simplicity.
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Another user-friendly, fool-proof
aspect of Simplicity is that it
prompts each individual user to
enter the correct information at each
stage of the documentation or
reporting process.
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Whenever a system entry or alert
message indicates that a special
form or additional information is
deemed necessary for purposes of
protocol compliance or adherence to
Good Clinical Practices, Simplicity
responds by prompting the user to
complete the appropriate form and
suggests a procedure to follow with
regard to submission of such forms.
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For example, if inclusion or
exclusion criteria are violated during
the screening process at a particular
site, then Simplicity automatically
alerts all users with access to that
site of the violation.
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Subsequently, the system prompts
the study coordinator to document
the protocol violation and complete a
protocol exemption request that,
when completed and submitted, is
forwarded to project management
for approval.
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An example Protocol Exemption Request page from Simplicity.
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Upon successful completion of
Screening, Simplicity’s patent,
fully-electronic Randomization Plus
feature avoids the typical IVRS
hassle of extraneous, lengthy
telephone calls and less than
optimal, non-comprehensive internet
applications…And, at no additional
cost.
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The application’s protocol-specific,
custom-generated algorithm enables
error-free, swift stratification of
subjects into appropriate
randomization arms. In doing so,
the system allocates the appropriate
investigational product to each
subject given the arm to which they
are randomized.
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Furthermore, the system maintains
an ongoing account of each
subject’s dispensed and return
investigational product while also
calculating their percentage of
compliance with the protocol.
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Lastly, all investigational product
inventory and tracking information
including: shipping invoices and
recipient records are maintained in
real time. Thus, all records are
instantly available to all users
24/7/365.
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An example Randomization page from Simplicity.
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During both scheduled and
unscheduled visits, responses that
require additional information to be
documented prompt the study
coordinator to document such
information on the appropriate form
in order to maintain GCPs and
adherence to protocol-specific CRF
Completion Guidelines.
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During the standard visit page pictured here, the user is prompted to
document a new AE due to recording a change in medical condition
that occurred during this visit.
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An example Visit page from Simplicity.
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When prompted by the system to
document a new AE, the study
coordinator may choose to:
Document the event at that precise
moment
- or -
Proceed without documenting the
event; which will cause the system
to generate an automatic query.
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The selection made in this example
was to record the adverse event. In
doing so, the event was also
documented as meeting serious
criteria.
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Such documentation further prompts
the study coordinator to complete
and submit an SAE report form to
Project Management and, if
parameters are set forth by a
specific client, to the site’s
Institutional Review Board.
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An example New AE page from Simplicity.
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The SAE report form generated by
Simplicity is completely proprietary
and was designed to exceed even
the most stringent requirements set
forth in the FDA Code of Federal
Regulations and ICH Guidelines.
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Additionally, the customizability of
Simplicity allows for any form, SAE
report or otherwise, to be adapted
and implemented into the system for
protocol-specific use by each
individual client.
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An example SAE Report page from Simplicity.
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Simplicity makes the usually
cumbersome task of Source
Document Verification efficient and
easy. Any new CRF page that is
being documented appears as a
new window and clearly pre-labels
each required entry.
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Items that require SDV for each
particular CRF page can be marked
off individually or collectively by
checking the “Select All” box as
shown here.
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In cases where a CRF page has been
partially documented, but not
completed, the page will appear as a
tabbed entry rather than in a new
window. Page editing is easily
accomplished in this scenario by
simply checking the appropriate
boxes pertaining to tasks recently
source verified and selecting the
“Update” button.
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In the interest of creating a historic
document for audit purposes, any and
all modifications to the SDV pages are
identified with the user’s name, as
well as the date and time of each
modification.
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An example SDV page from Simplicity.
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At each client’s discretion, Simplicity
can designate that certain items such
as: Protocol Exemption Requests,
Protocol Violations, Protocol
Deviations, AEs and SAEs are
officially acknowledged when
witnessed by users of the system with
appropriate permission levels.
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This applies to Investigators,
Monitors, and Project Management
alike. The determination of which
items should require
acknowledgement is protocol and
client-specific. The application is
custom-tailored to meet these
parameters.
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An example Monitor Acknowledgment page from Simplicity.
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Query generation and resolution has
been greatly uncomplicated by
Simplicity. All query-related data is
live and allows queries to be
generated, addressed, and resolved
in a matter of minutes from literally
any location in the world.
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The Query Resolution Summary page shown here allows the monitor to
view queries in the system by individual site or collectively for all sites to
which the monitor is assigned.
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This page also maintains a cumulative record of query resolution
efficiency for each site and each monitor.
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Since Simplicity was designed to be
a complete Clinical Trial Management
System, the optional Administration
module enables Sponsors to fully
manage a clinical trial with a single
application.
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Various aspects of this module
include access to the protocol from
any page within Simplicity, pre-
formatted, protocol-specific letters,
contact lists, and SOPs.
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It also includes a full Monitor
Reporting system that utilizes pre-
formatted, protocol-specific report
templates. These reports may be
completed by the monitor, submitted
to and reviewed by Project
Management all electronically and all
in real time.
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An example narrative page of a typical Interim Monitoring Visit Report page
from Simplicity.
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All report forms will be designed with in-depth aid and input by client or from
client-specific, proprietary forms.
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The CTMS feature of Simplicity also
incorporates a complete Regulatory
Tracking module. Regulatory
documents can be reviewed,
documented and tracked for individual
sites or for an entire clinical trial in
real time.
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All document categories are clearly
displayed on tabs that emulate hard
copy regulatory binders. In addition
to categories, documents are
identified by name and ICH code.
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An example Regulatory Tracking page from Simplicity.
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To exceed the most stringent
requirements set forth in the FDA
Code of Federal Regulations and ICH
Guidelines, Simplicity uses a
proprietary “Page Versioning” feature.
This feature allows a user to track
changes made to every CRF page
and report form within the system.
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Any page or report form that is altered
generates a brand new page with the
newly input information while
simultaneously preserving the original
page as an un-editable document.
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Page version numbers are assigned
to the newly incremented pages and
can be easily reviewed by scrolling
through these historical documents.
In short, once a document has been
changed, it can never be changed
again. It’s easy, fool-proof, and
unbreakable.
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Thank you for your time and attention to this overview presentation of
Simplicity . For more detailed information or to schedule a face-to-
face or WebEx demonstration of Simplicity , please visit our website:
www.software-dyanamics.net