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Query Log is real time online application designed specifically to handle all the issues associated with query generation and resolution. Based on the proven and highly successful Simplicity CTMS/EDC clinical trial software, Query Log establishes a live communication network between Monitors and Study Coordinators so that issues dealing with trial documentation can be quickly and effectively resolved in real time from any location in the world. Additionally, Query Log can host multiple studies simultaneously, so queries from many studies can all be managed from a single place.

Query Log is 1. Fully encrypted and has security standards equivalent to an Internet Bank 2. Exceeds all the requirements of CFR21 Part 11 and HIPAA for Electronic Medical Records3. Costs LESS to deploy than the retail price of its individual components4. Includes a complete technical support system.

Monitoring a clinical trial is all about quality assurance and compliance. Queries are an integral part of clinical trial management and Queries are one of the most valuable tools used by Monitors to achieve these end goals. However, due to the distances between sites and brevity of visits, Query generation and resolution is one of the most time consuming aspects associated with the management and operation of clinical trials. Ranking number three in visit time consumption behind source document verification and regulatory document management, query resolution actually costs more in real dollars than both the number one and number two time areas combined. Since the methodology involved with queries continues after a Monitor leaves a site, it eventually and often takes the form of a Federal Express vehicle, resulting in ancillary expenses that can be astounding.

Query Log - Overview

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System Architecture

Software-Dynamics channels all access to the application through our encrypted secure website, even though no actual patient information is ever revealed.

The Query Log primary application server and primary database server are hosted at the Los Angeles NOC, directly on the primary backbone of the Internet. The server connections consist of full gigabyte bandwidth. The primary on site backups are also located at the center. Back ups to CD media are done regularly and the data is stored offsite at our office location in Lancaster, California.

Each of the application and database servers in the group are equipped with Raid 5 hard drive arrays of the hot swap type, making any data loss, or even downtime, nearly impossible. When requested, a secondary cyber center clone can be installed at our alternate base hub in Palo Alto, California. The 300 miles between locations is designed to insure that even an ‘Act of God” event will not affect the uptime of the online application.

Standby Backup

This is how the automatic reroute of the offsite Standby Backup system is designed to work, in the event of a dual onsite failure of a catastrophic event.

Software-Dynamics uses Dell and HP multiple processor rack mounted servers exclusively. Contrary to an industry that that overuses the term “Virtual” and uses a single server to host information for multiple clients and thereby relies on software for client separation, each Query Log client is hosted on a unique physical server. Although each unit has the capability and associated software to host hundreds of applications, there is never an overlap of clients from different sponsors. If you host multiple studies, all your applications will be hosted in a unique single location. Even clients that are hosting a single study are afforded the same structural architecture.

Dell Power Edge Server HP Pro Reliant Server

At the conclusion of a study, the hard drives are backed up to disk or tape media and the actual hard drive(s) and media are given to the client to assure a permanent and secure record.

Included Hardware

Software-Dynamics uses both Oracle and Microsoft databases for back end data storage. Full licensing for unlimited use of these applications are all inclusive with each installed version of Query Log.

Included Database Software Applications

When we discuss pricing later in this presentation, you will be pleased to discover that, due to our special relationship with these companies, Software-Dynamics is able to deploy the complete Query Log system to our clients for less than the Enterprise Solution cost of an Oracle database system alone.

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System Security

Query Log data transfer is fully protected using a 256 bit SSL encryption system.

Access to the live network requires a user-unique electronic signature accompanied by a constantly changing encrypted pass code. Such strict measures secure Query Log to the extent equivalent to that of a virtually impenetrable global internet banking system.

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Query Resolution Logic

The logic of Query Resolution is an industry standard that has been developed over the course of the history of clinical trials. With minor enhancements, Query Log follows this familiar and well established pattern, making the application easy and intuitive to use. Here is how it works.

1. A Monitor issues a query.2. A Coordinator proposes a resolution

to the query.3. The Monitor now responds to the

proposed resolution accordingly in one of three ways.

a) The Monitor can REJECT the resolution and return it to the system. The Coordinator must now propose a new resolution.

b) The Monitor can accept the new resolution PENDING. The query is tagged accordingly and when the actual changes have been made, the query is returned as being ready to be resolved.

c) If the Coordinator has proposed and made the changes, the Monitor, upon verification, ACCEPTS the proposed resolution and closes the query, which creates a historical and un editable document.

Query Log greatly simplifies query resolution. Once a Query is generated, all a monitor has to look for is a proposed resolution and address it accordingly. A Coordinator checks for newly issued queries and responds to them with a resolution; then follows them up according to their entered status of Rejected or accepted Pending. Any queries that are initially responded to with an acceptable action are immediately closed and historically filed.

Query Log documents each proposal and records the progress and history each step along the way using a secure live network. Changes that are entered into the system are all done in real time and are instantly accessible from any location in the world over a secure network.

It’s Simple. It’s Fast. It’s Secure.

It’s Accurate!!

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Getting Started

Users get easy but secure access to the application at a specially prepared home page. Although no actual patient information is ever revealed using the Query Log application, this initial stop over allows Software-Dynamics to channel all access to the application through our encrypted secure system. This design serves the following additional functions:

• It provides a unique path for qualified system users. • It adds a redundant security layer to the application.

• It gives users immediate knowledge of changes and updates to the application, prior to official log in.

All current drug studies are listed in the drop down list on the Log In page. All user names are unique and are only associated with the study drug that they are assigned to. Selecting a drug study that is not associated with the users unique log in name will result in a failed entry attempt.

Query Log features fast and secure password assistance features to make error handling easy and painless. The system’s secure internal notification system ably assists users so that more time is spent working and less time is spent “remembering” the entry point requirements.

Finding Your Study

After initial log in qualification, the user is transported to a unique Alerts and Announcement page. Since communication is key to query resolution, Query Log incorporates several proprietary communication venues. A proprietary Message System is used for instant online communication between all system users and a Callback Request System is also alerted from this page. Additionally, announcements to particular “groups” of users, such as monitors, coordinators, and managers are also displayed here.

To further enhance security, and prior to access to the actual database, Query Log users make use of an electronic signature to proceed into the application. This additional layer of security assures that the user is fully qualified prior to being able to access the stored information.

Alerts and Announcements

Prior to entry, each user must accept the responsibility for the information that has been given to them via the Alert and Announcement page. This assures the messages, announcements and required actions that are communicated from the sponsor have been read, understood, and will be acted upon in due course. Permanent records of all log ins and log in attempts are kept by the system administrator and can be reviewed for accuracy in the event that required actions are not attended to in the desired way.

User Tracking

The main page of the Query Log application was designed to be simple to use and easy to navigate while affording the user access to a variety of features. The application’s “intelligent” technology sets up the page accessibility options based on the information stored about the user. Area’s of inaccessibility become apparent if a user attempts to access an area that is not within the range of their defined scope. The top of the page identifies the Sponsor, study drug and phase of the project. If the user is a Monitor or has Monitor privileges, a site selection menu is visible. If not, Coordinators will see their site assignment labeled. Completing the header bar is the date, the user’s name and their title.

Main Page

Query Log was designed to pass along stored or selected information and to limit choices about entry whenever possible, minimizing errors that could normally occur from transcription, indecision, or lack of knowledge about specific content. This will become more apparent as individual aspects of the application are explored.

The Alerts and Announcement page can be revisited by selecting the first tab on the menu bar. This makes it easier to review the announcements and take any necessary action without having to exit the application.

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Creating and Resolving Queries

Selecting the Query Summary tab from the menu bar loads the Query Summary Page. If the user is a Monitor, all sites that are referenced by use for that monitor that have any Queries assigned to it will be listed in the summary page. The Monitor can limit viewed queries to any particular site by selecting a site from the drop down list and then reselecting the Query Summary tab. To revert back to the full list, simply select the “Show All” link on the page.

The summary page shown here displays the previous selection made from the menu, however, this time the results are limited to queries at Site IT102.

To view a query in its entirety, click on the select button for the line number of the query you wish to view. This will load the complete query history file to the screen.

Here, Query ID # 145 has been selected for viewing. The Query headings show the following information; Status, Page Id, Page Number if applicable, the Query Id Number, Site Id, and the Screening Number of the patient. Also shown is the issue date and the issuer’s Id and Title.

In this case, the Monitor has reviewed the query, found the proposed resolution acceptable, verified that the changes have been made, and has answered the query by selecting the “Resolution Accepted” option from the selection list, This query has now been closed. Please note that the Coordinators Proposed Resolution checkbox has been deactivated and cannot be selected by the Monitor.

Once a Query has been closed, it becomes a historical document and can never be written to again. However, it can be viewed in it's entirety at any time by selecting it from the list on the Query Summary page. Note that the query above is fully accessible, however, the ability to write to it, edit it, or to select any change of status has been annulled, as indicated by the grayed out boxes and buttons.

Creating a new query for a subject could not be easier or faster. Once you have identified the site from the site selector list, select the ‘New Query’ tab from the menu bar. All the information that you need to complete a query, except for the query issue itself, is automatically pre loaded into the “Add a Query” document. All entered screening numbers for the selected site will appear in the drop down list marked ‘Screen #’. Any page that is allowed to have a query posted to it will also appear in the drop down list marked ‘Page’. If there are multiple pages for a particular document, such as a Visit, the number box will be activated.

Submitting this document will place it in the query summary page where it can be responded to immediately by anyone with the correct authorization from any location in the world….24/7.

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The Message System

Resolving queries quickly and accurately is all about communication. Query Log makes several additional tools available to enable Monitors and Coordinators to resolve document issues quickly and accurately. The Query Log message system is a proprietary device which can be used to assist in query resolution. The information and recommendations that can be exchanged here can greatly reduce the time and banter that inherently come with query resolution. Queries can be simultaneously reviewed and answered without ever leaving the system, and Messages can be created, stored or deleted with ease. Shown here is the main message page of Query Log. Messages are clearly marked as opened and/or read. Alerts let users know if there are unread messages and all messages are hosted on a secure server that cannot be accessed by any internet system.

Clicking the select link on the main message page loads the message in a new window where it can be acted upon. Once deleted, a message can never be recovered by a system user, however, the Query Log database maintains a record of every submission and a system administrator can retrieve any communication if were ever needed.

Creating a new message is just as easy. Additionally, Query log only allows messages to be sent to available recipients as defined by the site selection menu. To send a message, simply select the site for the person that you want to contact and the list box on the mail page will be customized just for that site. Message sending errors are eliminated and messages to the wrong party or transcription errors are impossible. Message delivery is literally instantaneous, working as quickly as an instant message system in cyberspace, and internal value encryption make all communications 100% secure.

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Statisitcs

Statistical analysis of query resolution by site and by the Monitor or Coordinator is instantly available to each Query Log user. Monitors can view a live analysis that combines all their assigned sites records collectively or they can view their current resolution statistics at any given site by selecting that site from the drop down list. When selected, both collective and individual site values are displayed side by side. Coordinators will be shown the same values, but will only be able to view the site that they are assigned to. All values are instantly updated anytime a page is reloaded.

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Site Administration

The Query Log Administration panel is a permission only page. This is where system users, subjects, and user information is defined, edited, and stored. The permission level can be adjusted as per the desire of the Sponsor. The default setting is for use by a system administrator, however, it can be set to allow for monitor access (as a group) as well. Additionally, announcement page content is created and edited here and the Query Log Callback feature, if installed, is also monitored from this page.

Adding users into the application is a fast and easy process. The basic information can be inserted in just a few minutes and user access to the system is immediate after completion of an entry. In order to preserve historical documentation, once a user is in the system, that user can never be completely removed. However, any user can be deactivated at any time, which prevents them from ever accessing the system again..

Editing a users information is also quick and easy. Non editable fields are back colored in gray. All other fields are editable. Changed information is immediate upon submission, therefore, changing a users status from “Active” to “Inactive” immediately negates that users ability to access the system. All changes, including the date, time, and person who made the edits are permanently recorded and can be reviewed at any time.

A complete list of all users assigned to the study, with their basic contact information, is available from the View Users screen. Users are automatically sorted from A to Z by the users last name for easy location.

Any subject that is to be referenced for a query must first be added to the system. The basic information, as to Site and Study ID, is automatically entered by the system based on the Site selection dropdown list and the users Study Id assignment. Simply enter the subjects Screening Number to complete the process. Query documentation for an entered subject is immediate upon submission. If a subject is already in the system, an alert will inform you of their previous submission and their name will appear in the drop down list of the Add Query page.

A complete list of all queries entered for the study is available by selecting the Query History link on the Administration page. The entire list can be sorted in 5 different ways; by Screen Number, Status, User, Date, or Site.

Software-Dynamics is a customer service oriented company that believes in constant product improvement. We highly value the opinions of the professionals that use our applications and are always interested in new ideas regarding the collection, inclusion and display of information. We have therefore supplied a direct contact page in Query Log where any system user can comment about any of the program’s features or request information from any of our departments. When a reply is requested, we do our best to supply an answer within 24 hours.

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Assistance Messages

Whenever an event or action is improperly introduced or additional information is required to complete a request, Query Log will alert the user with an assistance message to help the user with completion of a task. The warnings or suggestions are clear and concise and will usually allow the user to quickly complete the required action. In the example above, a Monitor attempted to generate a new query without first making a site selection. Since the available list of subjects is dependant on the site selected, Query Log alerted the user to select a site from the drop down menu.

Following are few examples of typical Help or Alert Messages that might be encountered using Query Log.

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Deployment

A Query Log application, with your choice of selected features, can be ready to use as soon as 5 working days from the time that your request is filed.

Because Query Log is not specifically dependant upon user or subject history, existing studies can benefit from the use of Query Log. Large scale studies that are already underway can have their Query Management quickly and easily brought up to speed, greatly enhancing data management ‘s ability to get to data lock and final drug evaluation.

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Pricing

A Query Log application for the entire length of a drug study, including all hardware, software, unlimited users and technical support, costs less than the purchase price you would pay for the actual hardware (Servers), supporting software (Databases and Operating Systems) and hosting.

Because Query Log can include, at your request, additional optional services, each installation is priced accordingly. We would be pleased to reply to your request for an exact quote, based on your study, immediately upon receipt of your study parameters. Software-Dynamics also applies discounting to every study run concurrently with the initial study, so sign them all up and manage queries from all your trials in a single place!

For an Exact Quote on One or Mores Studies:

Please visit our website at www.software-dynamics.net and select Query Log from the menu.1. Enter your study Parameters.2. Select “Get Price Quote”

A representative will contact you …WITH THE QUOTE … within 24 hours!

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Live Demonstration

Software-Dynamics will be happy to provide you with a live demonstration, either at your facility or through an online event. Please contact us at admin@software-dynamics.net

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In addition to Query Log:1. We also host Simplicity©, the most complete CTMS/EDC system in the industry today.2. We can create a custom proprietary Electronic Medical Record system for any hospital or medical agency.

Thank You

Thank You … for taking the time to review the Query Log application. Software-Dynamics takes great pride in being at the forefront of Electronic Data Capture and Medical Records for the Pharmaceutical industry.

We look forward to hearing from you…