The AMPS back-end trial

database solution

TrialPerfect

TrialPerfect is the AMPS back-end

database that completes the well-know

CalECG product, the AMPS on-screen

measurement tool, providing a complete

solution for you clinical trials. TrialPerfect is

21 CFR Part 11 compliant.

TrialPerfect Introduction

• TrialPerfect is web-based.

• It combines a centralized relational database and

allows to integrate the CalECG measurement tool.

• Data (ECG or annotations) is never stored on the

user's workstation.

• The management of the annotations is completely

handled by the TrialPerfect back-end and includes a

complete audit trail.

• TrialPerfect can support all file formats supported

by CalECG, such as Mortara E-Scribe XML, Muse

transactional XML, HL7 XML…

TrialPerfect Introduction II

• The ECG files are stored on the server in study

specific folders. Files found in the study specific

folder will be considered as candidates for entering

into the TrialPerfect system.

• Demographic data may be hidden (blinded) to the

Reader. This feature (among others) can be

configured by the administrator at the Study level.

• TrialPerfect can automatically create HL7 XML FDA

that can be directly submitted to the FDA Warehouse.

• The system allows for intra-reader and inter-reader

variability assessment for quality purpose.

TrialPerfect Details

TrialPerfect can handle five types of roles (Actors)

whom take part in the whole Clinical Trial process:

• Application Administrator

• Project Manager

• Reader

• Reviewer

• Monitor

All actors access TrialPerfect via login/password

TrialPerfect Roles

Application Administrator

(Administrator) manages:

• The creation of TrialPerfect system users, logins and default

system user permissions

• Initial study creation

• Definition of the study specific folders where the ECG files

are to be placed

• Assigning a Project Manager to the study

Application Administrator

manages:

• Basic Study configuration

• Study name, study priority, study start and end date, ... and

much more

• User configuration

• Associates Readers, Reviewers and Monitors to a study

• Sets User Permissions on a per study basis

• Assignment of ECGs to a study

• ECGs may be assigned to Readers manually

• Auto assignment rules (based on ECG demographics) may

be configured into the system

• Configuration of the ECG measuring protocol

• List of desired/required measurements (ex. QT, RR, PR,

etc.)

• Ability to specify that measurements should be done on

either rhythm data or representative beats as well as

specifying particular leads

Project Manager

Project Manager II

Main view

Project Manager

Reader

Reader (initial annotator) is a user that can generate

and save annotations

• A Reader logs-in into the process from a local workstation,

and the ECGs assigned to the Reader are automatically

dispatched by TrialPerfect

• TrialPerfect guides the reader through the measurement

process, using the AMPS CalECG measuring tool, making

sure at all times that only the required-by-protocol

annotations are measured

• Reader permissions may be configured on a study by study

basis and on a Reader by Reader basis.

Reader II

Reader

Reviewer

Reviewer: reviews the ECGs annotated by a Reader

• Reviewer has the possibility to visualize the ECG with

previous annotation and make adjustments if needed.

• Once again the system creates a complete audit trail of all

actions on undertaken on any one ECG

Monitor

Monitor: oversees the status of a study from the

Sponsor side

• Study status

• Number of ECGs read, number of ECG received, time to

expected delivery date, etc.

• May view annotations of any one ECG

TrialPerfect version 1.0.0 complies with the rulings

described in 21 CFR Part 11 and the Guidance for

Industry: Computerized Systems Used in Clinical

Investigations (May 2007).

21 CFR Part 11 Compliancy

For questions, additional information, or a price proposition

please contact:

E-mail: Marketing@amps-llc.com

Web: www.amps-llc.com

418 Central Park West suite 21 - 10025 - New York - New York

Via Paolo VI, 34 - 25018 - Montichiari (BS) - Italy

127 rue de la Glaciere - 75013 - Paris - France

AMPS LLC