The AMPS back-end trial
database solution
TrialPerfect
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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
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• 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
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• 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
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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
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(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
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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
Project Manager II
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Main view
Project Manager
Reader
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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
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Reader
Reviewer
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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
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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
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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
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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