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.

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.

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.

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.

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.

If desired, an additional

secondary server housed in a

secure, remote location can also

be included with any system

configuration.

Following initial password

authorization, Simplicity greets

each individual user with an Alerts

and Announcements page that

highlights any activity that might

require immediate attention.

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.

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.

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.

An example Schedule page from Simplicity.

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.

This design technique was fueled by

the understanding that all CRF

entries are divided into just two basic

categories:

Visits

and

Events

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.

An example Screening page from Simplicity.

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.

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.

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.

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.

An example Protocol Exemption Request page from Simplicity.

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.

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.

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.

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.

An example Randomization page from Simplicity.

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.

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.

An example Visit page from Simplicity.

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.

The selection made in this example

was to record the adverse event. In

doing so, the event was also

documented as meeting serious

criteria.

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.

An example New AE page from Simplicity.

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.

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.

An example SAE Report page from Simplicity.

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.

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.

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.

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.

An example SDV page from Simplicity.

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.

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.

An example Monitor Acknowledgment page from Simplicity.

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.

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.

This page also maintains a cumulative record of query resolution

efficiency for each site and each monitor.

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.

Various aspects of this module

include access to the protocol from

any page within Simplicity, pre-

formatted, protocol-specific letters,

contact lists, and SOPs.

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.

An example narrative page of a typical Interim Monitoring Visit Report page

from Simplicity.

All report forms will be designed with in-depth aid and input by client or from

client-specific, proprietary forms.

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.

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.

An example Regulatory Tracking page from Simplicity.

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.

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.

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.

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