Noesys Data Launches a New Data Service to Identify and Classify Arrhythmias in Safety Pharmacology Studies at 10th Annual Safety Pharmacology Society Meeting

During the annual meeting of the Safety Pharmacology Society in Boston Noesys Data unveiled a service that reviews cardiac safety study data for the occurrence of arrhythmia. A panel of Board Certified veterinary cardiologists to provide expert review and customer reports.

Boston, MA, September 24, 2010 --(PR.com)-- During the annual meeting of the Safety Pharmacology Society in Boston Noesys Data unveiled a service for pharmaceutical development teams and CRO's performing safety pharmacology studies. The service takes the very large data sets generated during cardiac safety studies and reviews them for the occurrence of arrhythmia. The company has teamed up with a panel of Board Certified veterinary cardiologists to provide expert review and customer reports.

Tom Bennett, Director of New Business Development for Noesys Data states; “The new service is unique in that we review multiple 24 hour periods of data on a beat-by-beat basis. We will compile data for each subject in the research colony to determine the subject’s naturally occurring pattern of arrhythmia. From that documented frequency and characteristic of naturally occurring events in the subject a researcher can more precisely detect any cardiac effects a drug candidate may present."

Noesys Data is uniquely qualified to offer this service. It does this by using its Artios™ integrated database suite. Artios provides the platform to store and analyze these very large datasets one a subject-by-subject basis enabling Noesys Data to create baseline database.

Once the baseline database is established, any changes from that baseline can be attributed to an experimental treatment. Bennett adds; “This methodology is a significant improvement over current practices. Our customers are very excited about this service. The response from the attendees at the Safety Pharmacology Society annual meeting has be very positive and we are already discussing how we can help a significant number of its members get more information out of the data they are already collecting."

To perform the service, Noesys Data uses raw data files the customer is already generating. No new equipment or headcount are required to utilize the service.

Noesys Data’s trained data specialists will review full physiological data sets (telemetry, tethered, or anesthetized protocols) to identify irregularities in the recorded ECG. These portions of the ECG data set will subsequently be assessed to determine the following:
1) Does the detected irregularity represent a true abnormality or artifact
2) Identified true arrhythmia will be further characterized to include
a. the type of arrhythmia
b. timing (premature or late "escape" beats)
c. origin (supraventricular or ventricular),
d. morphology - consistent (monomorphic) or variable (polymorphic)
e. occurrence- singly, in pairs, or runs of abnormal beats
f. electrocardiographic features of torsade will be identified if observed

Reports will be generated, reviewed and issued by a Board Certified Veterinary Cardiologist (Diplomate ACVIM: Cardiology).

Data sets can include:
· Individual subject data – to determine the nature and frequency of irregular heartbeats in an single subject,
· Experiment data -– to compare drug effect is a group of subjects
· Study Data sets – to evaluate rising does effects such as in a Latin Square experimental design, and
· Colony data sets- to establish baseline occurrence of irregular heartbeats inherent in each member of the colony

The data will be incorporated into Artios, the whole animal database from Noesys Data, to establish normal baselines levels of cardiac irregularities on a subject by subject basis.

Statistical analysis of the observed characteristics is available.

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Noesys Data
Mark Vander Hoff
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www.noesysdata.com
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