AMPS-QT is a quarterly journal dedicated to all the people and organizations involved in the world of cardiac safety. Published by AMPS LLC, it covers all aspects of methodology and software technology related to clinical trials and Thorough QT studies.
All published AMPS QT can be downloaded from the AMPS QT page.
AMPS-QT is a quarterly journal dedicated to all the people and organizations involved in the world of cardiac safety. Published by AMPS LLC, it covers all aspects of methodology and software technology related to clinical trials and Thorough QT studies.
All published AMPS QT can be downloaded from the AMPS QT page.
AMPS is proud to announce the official release of FAT-QT (Fully Automatic Thorough-QT) the tool that combining the features of two successful and recently enhanced AMPS tools, namely CalECG v3 and the FDAEcg Suite v2, provide in one single tool the capability to perform a fully automated analysis of 12-lead ECGs.
Taking advantage of the much improved measurement algorithm of CalECG v3, as well as the enhanced filters recently developed for the AMPS FDAEcg Suite scoring module, FAT-QT has the capability to greatly reduce the amount of time needed to analyze ECG traces in the contest of Thorough-QT studies in particular, and in clinical trials in general, by pre-processing, measuring, and then sorting all the ECG traces in different sets.
With FAT-QT ECGs are at first automatically annotated with the new and improved algorithm of CalECGv3 and then, using different scoring metrics, the ECGs are sorted in categories, based on quality. Both the scoring metrics and the number of categories are configurable and selectable by the user. At the end of the process, minutes later, good quality classified ECGs would not require any further expert review, greatly reducing the need for manual review analysis on a small subset of ECGs for each study, and thus allowing safer, faster, and cheaper processing of large amount of ECG traces.
FAT-QT has proven to be so effective and reliable from the first development phase that several of the major AMPS customers had already requested to use it in beta-version and even licensed the product while still in the final validation phases, and are now receiving the first official production release.
About AMPS LLC: AMPS LLC, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring and is well known for the support given to the FDA for the establishment of the HL7 XML ECG standard and for providing FDA Officials with the famous AMPS XMLFDA Viewer tool. The company’s website is www.amps-llc.com.
AMPS LLC is pleased to announce the release of version 3 of CalECG, the popular AMPS application for the on-screen measurement of ECG signals in the context of pharmaceutical trials, capable to handle digital ECGs, and seamlessly interfaced with several types of formats including the FDA HL7 xml.
CalECG v3 represent a major step forward compared to previous versions of the tool, as it provides a totally redesigned and more ergonomic graphical interface, including display of ECG signals in predefined format, such as 3 X 4, 6 X 2. Thanks to the feedback from customers and intense research work much care has also been put in enhancing the automatic algorithm for annotation measurements with abnormal beat classification. Last but not least CalECG v3 also includes, as an optional, a diagnostic algorithm, which has been integrated thanks to the cooperation between AMPS and the University of Glasgow.
About AMPS LLC: AMPS LLC, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring and is well known for the support given to the FDA for the establishment of the HL7 XML ECG standard and for providing FDA Officials with the famous AMPS XMLFDA Viewer tool. The company’s website is www.amps-llc.com.
AMPS-QT is a quarterly journal dedicated to all the people and organizations involved in the world of cardiac safety. Published by AMPS LLC, it covers all aspects of methodology and software technology related to clinical trials and Thorough QT studies.
All published AMPS QT can be downloaded from the AMPS QT page.
AMPS-QT is a quarterly journal dedicated to all the people and organizations involved in the world of cardiac safety. Published by AMPS LLC, it covers all aspects of methodology and software technology related to clinical trials and Thorough QT studies.
All published AMPS QT can be downloaded from the AMPS QT page.
AMPS-QT is a quarterly journal dedicated to all the people and organizations involved in the world of cardiac safety. Published by AMPS LLC, it covers all aspects of methodology and software technology related to clinical trials and Thorough QT studies.
All published AMPS QT can be downloaded from the AMPS QT page.
AMPS LLC is pleased to announce the release of ViewECG, the tool capable of rendering/displaying on the MS Windows platforms annotated ECG HL7 XML files (the XML format endorsed by the FDA), as well as the majority of ECG formats of the industry (E.g.: Ishne, Mortara EScribe and HScribeXML, GE Muse and Cardiosoft XML, Philips Sierra XML v.1.03 and v.1.04, and Schiller RST).
Based on the well known AMPS FDAEcg Suite platform, ViewECG provides the functionality of a general-purpose MS windows ECG trace viewer and it’s the ideal solution for Core Labs, Hospitals, Research laboratories and anybody in the need to view ECGs traces generated with machines from different manufacturers, as well as the standard FDA HL7 XML file format, via just one common interface.
ViewECG has been successfully integrated into commercial Data/Patient Database hospital platforms allowing physicians to gain access and view ECG traces in their original formats both via the hospitals local area networks and the Internet.
About AMPS LLC: AMPS LLC, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring and is well known for the support given to the FDA for the establishment of the HL7 XML ECG standard and for providing FDA Officials with the famous AMPS XMLFDA Viewer tool. The company’s website is www.amps-llc.com.
Over one year ago AMPS announced the sunset of the well known XMLFDA Viewer product and the release of the AMPS FDAEcg Suite, the modular AMPS solution for the HL7 xml format ECGs, which included an extensive set of qualitative and quantitative tools ranging from ECG quality scoring to HL7 XML validation at different level.
The success of the AMPS FDAEcg Suite proved that, beyond the increased functionality, the new graphical interface and the redesigned menus struck a responsive chord.
AMPS LLC is now pleased to announce the release of the AMPS Viewer Light. This new product is replacing the old XMLFDA Viewer Light and it provides the much improved graphical interface of the AMPS FDAEcg Suite, as it is based on the same code. Similarly to the old Light product the new AMPS Viewer Light provides a way to display and validate one HL7 xml ECG file at a time.
In the last few years the XMLFDA Viewer Light has been widely adopted by the healthcare industry, ranging from pharmaceutical companies, Core labs, and private clinical practices. The new AMPS Viewer Light can be licensed from AMPS, like its predecessor, via a one-time charge. AMPS customers already owning a license of the XMLFDA Viewer light will be able to upgrade to the new product at a discounted fee.
About AMPS LLC: AMPS LLC, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring and is well known for the support given to the FDA for the establishment of the HL7 XML ECG standard and for providing FDA Officials with the famous AMPS XMLFDA Viewer tool. The company’s website is www.amps-llc.com.
The Telemetric and Holter ECG Warehouse (THEW) is a cardiac research initiative developed by the University of Rochester Medical Center (URMC) in partnership with the Food and Drug Administration (FDA).
Today,AMPS and the THEW announce an agreementaround the sharing of a number of key software programs needed to convert the data uploaded to the THEW repository into a common standard format.
"We are delighted to contribute with our technology to the THEW program," said Fabio Badilini PhD, Chief Scientist at AMPS. He continued, "Our company is a leader in developing software tools which are compatible with almost every existing ECG format on the market and we therefore were in the best position to help and provide tools that would allow the conversion of all the data submitted to the warehouse into a unique seamless standard”.
AMPS in particular provided, among other tools, Antares, a powerful software tool dedicated to the Holter environment, capable to intelligently extract strips from most commercial holter recordings and produce standard output formats such as ISHNE and FDA HL7 xml.
The THEW director, Dr. Jean-Philippe Couderc, PhD commented, "We are glad to have AMPS LLC as a member and a contributor toour initiative. The THEW has received large sets of ECG data from pharmaceutical companies that were recorded using different equipments. Our effort has been directed toward the conversion of these data into a common format in order to ensure consistency across databases within the THEW. The technologies provided by AMPS LLC have greatly facilitated these tasks and, today, the warehouse hosts these databases and their associated clinical information consisting in 800 Holters equivalent in size to ~6.9 million 12-lead standard ECGs."
About THEW: The Telemetric and Holter ECG Warehouse (THEW) is a not-profit organization hosted at the University of Rochester (UR) Medical Center (NY).The THEW is a research platform for sharing data, tools and expertise for the development of ECG-related technologies. The THEW benefits from the scientific and technical heritage of the Heart Research Follow-UP program which has more than 20 years of research experience in quantitative analysis of ventricular repolarization involving animals, normal subjects, patients with genetic (Long QT Syndrome) and acquired cardiac disorders.
Striving to advance the field of cardiac safety, the THEW initiative is developed under an agreement with the Food and Drug Administration for facilitating collaborative discussions between THEW members, and for leveraging resources to implement joint projects among FDA, UR, and other public and private stakeholders. The THEW is led by individuals from the UR, the Commissioner Office of the FDA, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. More information can be found at
www.thew-project.org.
About AMPS llc: AMPS LLC, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring and is well known for the support given to the FDA for the establishment of the HL7 XML ECG standard and for providing FDA Officials with the famous AMPS XML Viewer tool. The company’s website is www.amps-llc.com.
New York, NY (August 4, 2008) – Clinilabs, Inc., a specialty contract research organization (CRO), collaborated with AMPS, LLC to create TrialPerfect version 1.0.0, AMPS back-end database system that completes the well-know CalECG product, the AMPS on-screen measurement tool, providing a complete solution for clinical trials.
For the development of this innovative software, Clinilabs provided support to AMPS from clinical and core laboratory perspectives. Clinilabs’ collaboration with AMPS to produce TrialPerfect gives it a competitive advantage and assures sponsors of service that is incomparable to other vendors of ECG Core Lab services.
“TrialPerfect enables us to efficiently handle ECG data obtained from single-center studies to large, multicenter clinical trials. This application, along with Clinilabs’ proprietary methods, allows us to offer exceptional service at competitively low cost to pharmaceutical and biotechnology companies that expect only the best,” stated Dr. Gary Zammit, Clinilabs’ President and CEO.
Fabio Badilini, Chief Scientist at AMPS commented, “We are very pleased with the fruitful cooperation we have developed with Clinilabs for the development of TrialPerfect. Nowadays AMPS has the capability to offer a full key-in-hand package to its customers.”
The first installation of TrialPerfect was conducted at Clinilabs. The combination of TrialPerfect and CalECG offer a safe client/server environment for the storage, analysis, interpretation, validation, and review of ECG traces in the context of clinical trials.
About Clinilabs, Inc.
Clinilabs is a specialty contract research organization (CRO) that provides a full portfolio of services to pharmaceutical, biotechnology, and medical device companies involved in the development of central nervous system (CNS) and cardiovascular (CV) therapeutics. The Company also provides early phase services in a wider range of therapeutic areas at its Phase I facility. Established in 2001, Clinilabs has provided services to more than one third of the world’s top 20 pharmaceutical companies, and has been involved in 7 successful New Drug Applications (NDAs) in central nervous system (CNS) and cardiovascular (CV) indications. For more information, please visit www.clinilabs.com.
About AMPS llc
AMPS LLC, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring. The company’s website is www.amps-llc.com.
Contact
AMPS, llc
418 Central Park West
New York, NY, 10025
Computers in Cardiology 2008 will be held in Bologna, Italy from September 14th to 17th.
The "Computers in Cardiology" conference provides an international forum for scientific presentations focusing on computer applications in clinical cardiology and cardiovascular research. The conference fosters interdisciplinary discussions and collaboration between physicians, engineers, physicists, biologists, computer scientists and others engaged in research in this area.
At Computers in Cardiology 2008, a new interactive exhibitor fair will be initiated, where AMPS will be present. This display opportunity is for those companies with innovative technology solutions in cardiology.
Different from a standard marketing exhibit, interactions between the developers of the software with all the conference participants are welcomed. Interactive displays will be available throughout the meeting with active interaction occurring during all breaks and poster sessions.
AMPS llc will also give its contribution to the Research Environment.
AMPS llc is pleased to announce the release of TrialPerfect version 1.0.0
TrialPerfect is the AMPS back-end database system that completes the well-know CalECG product, the AMPS on-screen measurement tool, providing a complete solution for your clinical trials.
The main characteristic of TrialPerfect and CalECG is to provide a professional, safe and user friendly client/server environment for the storage, analysis, interpretation, validation and review of ECG traces in the context of clinical trials. TrialPerfect is 21 CFR Part 11 compliant.
TrialPerfect offers a user-friendly Web interface whereby the management of the annotations is completely handled by the back-end process and includes a complete audit trail. The tool can support all file formats supported by CalECG, such as Mortara E-Scribe XML, Muse transactional XML, HL7 XML and many others.
TrialPerfect can handle five types of users whom take part in the whole Clinical Trial process, and in which the Program Manager (PM) holds the main role.
At study closure, TrialPerfect can automatically create HL7 XML FDA files. For a successful submission to the FDA Warehouse the HL7 XML files should be validated prior to the physical submission, using, for example, the AMPS FDA ECG Suite. The system allows also for intra-reader and inter-reader variability assessment for quality purpose.
The first Trial Perfect installation has been performed at Clinilabs Inc, New York, NY.
AMPS llc, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring. The company’s website is www.amps-llc.com.
For more information, please contact:
Fabio Badilini
Chief Scientist
AMPS, llc
418 Central Park West
New York, NY, 10025
AMPS llc is proud to announce that in the last few months, several leading Pharmaceutical corporations have acquired the AMPS FDAECG Suite for their ECG quality assessment. Among others AstraZeneca, Johnson & Johnson and Novartis have adopted the AMPS FDAECG Suite solution for the validation of HL7 files and noise quality assessment.
The AMPS FDAECG suite is the last product that has entered the AMPS portfolio, officially in October 2007.
The Suite is a new HL7 XML viewer that replaces and extends the previous XMLFDA Full Functional viewer from AMPS. Noteworthy extensions are the validation and scoring modules for the HL7 XML ECG traces. The validation module verifies that both the structure and content of the HL7 XML files meet the requirements embodied in the HL7 Schema and the HL7 Implementation Guide endorsed by the FDA. Thanks to the strategic alliance signed with Mortara Instruments Inc. in August 2006, the FDAECG Suite and the FDA ECG Warehouse produce a consistent set of syntactical warnings and error messages during the validation phase thus giving a consistent interpretation of the HL7 XML standard requirements.
The AMPS FDAECG suite scoring module measures the quality of the loaded ECGs. The Suite includes several predefined metrics that calculate the high and low frequency noise using non parametric algorithms, and in addition different user level metrics may be easily created by the customers using the SDK tool provided by AMPS with the product.
AMPS llc, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring. The company’s website is www.amps-llc.com.
Computers in Cardiology 2007 will be held in Durham, NC from September 30th to October 3rd.
The "Computers in Cardiology" conference provides an international forum for scientific presentations focusing on computer applications in clinical cardiology and cardiovascular research. The conference fosters interdisciplinary discussions and collaboration between physicians, engineers, physicists, biologists, computer scientists and others engaged in research in this area.
At Computers in Cardiology 2007, a new interactive exhibitor fair will be initiated, where AMPS will be present. This display opportunity is for those companies with innovative technology solutions in cardiology.
Different from a standard marketing exhibit, interactions between the developers of the software with all the conference participants are welcomed. Interactive displays will be available throughout the meeting with active interaction occurring during all breaks and poster sessions.
AMPS llc will also give its contribution to the Research Environment.
Martino Vaglio will be presenting A Fully Automatic Algorithm for the Analysis of Heart Rate Changes and Cardiac Recovery during Exercise in session S54: Computer Algorithms for Ischemia/Infarction on Tuesday October 2nd at 1 pm.
AMPS llc has announced the release of AMPS ECGScan version 3.0 and AMPS FDAECG Suite version 1.0.
AMPS ECGScan 3.0 is a tool used to convert paper ECG images to digital format. ECGScan 3.0 accepts as input scanned paper ECG images (several graphical formats are supported such as JPG, GIF and PNG), and through the application of several advanced wave detection algorithms, produces digitized ECGs in either AMPS digital format or HL7 XML (the format endorsed by the FDA). New to AMPS ECGScan 3.0 is the addition of several new image processing tools that both speed up the process of digitalization and enhance the accuracy of the waveform detection.
FDAECG Suite 1.0 is a new HL7 XML viewer that replaces and extends the previous XMLFDA Full Functional viewer. Noteworthy extensions are the validation and scoring modules for the HL7 XML ECG traces.
The validation module verifies that both the structure and content of the HL7 XML files meet the requirements embodied in the HL7 Schema and the HL7 Implementation Guide endorsed by the FDA. Thanks to the strategic alliance signed with Mortara Instruments Inc. in August 2006, the FDAECG Suite and the FDA ECG Warehouse produce a consistent set of syntactical warnings and error messages during the validation phase thus giving a consistent interpretation of the HL7 XML standard requirements.
The scoring module measures the quality of the loaded ECGs. The FDAECG Suite 1.0 ships with several predefined metrics that calculate the high and low frequency noise using non parametric algorithms, but new user level metrics may be created by using the SDK freely provided by AMPS.
AMPS llc, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring. The company’s website is www.amps-llc.com.
For more information, please contact:
Fabio Badilini
Chief Scientist
AMPS, llc
418 Central Park West New York, NY, 10025
AMPS LLC and Mortara Instrument, Inc. announce an agreement to align the HL7 XML validation process of the AMPS XMLFDA Viewer with the Mortara E-Scribe ECG Warehouse.
AMPS LLc and Mortara Instrument Inc agreed to cooperate in aligning the HL7 XML validation checks in a future version of the AMPS XMLFDA Viewer with those implemented by Mortara in the E-Scribe ECG Warehouse. The ECG Warehouse, currently in use by FDA for the import, storage, review and assessment of annotated electrocardiographic (ECG) studies, was developed by Mortara under a Cooperative Research and Development Agreement (CRADA) to support the Food and Drug Adminstration in assessing the cardiac safety of new compounds submitted for approval.
The E-Scribe ECG Warehouse requires all annotated datasets to meet the HL7 standard in order to be successfully imported into the warehouse. An import validation check is performed on each ECG upon upload. Any errors and warnings found in the import process are logged to report non-compliant elements and reasons for non-compliance.
The AMPS Viewer tool includes an independent HL7 syntax validation algorithm providing a verification of the annotated datasets at 4 different levels, addressing all issues related with the submission of the datasets into the FDA Warehouse.
By virtue of this agreement the two independent platforms will both produce, in the near future, a consistent set of syntactical warnings and error messages, during the validation phase prior to the submission to the FDA Warehouse. This software alignment will insure that all requirements embodied in the HL7 Schema and the HL7 Implementation Guide will be interpreted and flagged by the two products in the same fashion, thus giving a consistent interpretation of the HL7 annotated ECG standard requirements.
Justin L. Mortara, Ph.D., Vice President for Mortara Instrument commented, “Since the creation of the annotated ECG standard and the implementation of the ECG Warehouse in collaboration with the FDA, Mortara has worked closely with numerous Sponsors and ECG central laboratories to achieve consistent interpretation and implementation of the HL7 annotated ECG standard. The result today is that more than 250,000 annotated ECGs have been successfully imported into the ECG Warehouse, making them available for advanced web based review by both Sponsors and regulators using the Mortara VERITAS algorithm toolset. Alignment of the AMPS Viewer with the ECG Warehouse HL7 validation check will provide another mechanism for central laboratories and Sponsors to verify the syntax of their HL7 annotated ECG datasets prior to placement in the ECG Warehouse. This will further simplify the process of getting ECG datasets into the ECG Warehouse, which in turn will enable broader use of the Mortara ECG analysis and review tools developed under our CRADA with the FDA.”
Fabio Badilini, Chief Scientist at AMPS commented, “We are extremely happy of the fruitful cooperation we have developed with Mortara Instrument in the past years and this agreement confirms that both companies aim to enhance and facilitate the work to both FDA personnel throughout the review process and to sponsors who wish to enhance their cardiac safety assessment of new drugs”.
Mortara Instrument, Inc, based in Milwaukee, WI , is distinguished in the field of non-invasive cardiology for innovations that are the core of the company’s complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems and data warehousing solutions, and cardiology monitoring systems. The company’s website is www.mortara.com.
AMPS Llc, based in New York, NY, is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring. The company’s website is www.amps-llc.com.
AMPS-LLC is pleased to announce
the 4.3.0 version of the key product XMLFDA Viewer with the new
validation system. By using a plugin, XMLFDA Viewer 4.3.0 can validate
FDA XML files with various methods that range from the basic XML tests (well-formedness
and schema check) to the HL7 Implementation Guide conformity and a test
suite specifically designed to address all issues related to the FDA
Warehouse submission.
The XMLFDA Viewer is the product
that allows to display annotated ECGs saved in the FDA XML format.
XMLFDA Viewer 4.3.0 comes in two separate versions: a LIGHT version with
a number of basic functionalities, allowing to view and validate (well-formedness
and schema) one XML file at a time; and a complete FULL FUNCTIONAL
version with an extensive set of additional tools, allowing to view and
validate (FULL 4-LEVEL VALIDATION) multiple XML files at a time.
AMPS-LLC collaboration
with Daiichi Medical Research
AMPS-LLC and the
Translational medicine group from Daiichi Medical Research of Park
Ridge, NJ, USA (DMR) entered a research collaboration focusing on
methodological aspects of ECG quantitative analysis for detection of
drug-induced effects on cardiac repolarization. As part of this
collaboration, selected sets of reasting digital 12-lead ECG tracings
will be analyzed by AMPS on-screen measurement technology (CalECG) to
better understand the implication of different approaches to ECG
interval measurement on cardiac safety and on the quality of ECG
analysis. The first data to result from this collaboration were
authorized for use by Mortara Instrument of Milwaukee, WI, USA to
demonstrate the utility of the FDA Digital ECG Warehouse.
Dr. Fabio Badilini member
of the panel and presenter at the Think Tank Critical Path Initiative
In Bethesda MD, the FDA,
in collaboration with the Duke Clinical Research Institute, organized a
Cardiac safety and Critical Path Initiative Think Tank meeting aimed to
address key problematic issues related with drug safety, drug/device
combinations and implications of FDA ECG warehouse for therapeutic drug
development. Dr. Fabio Badilini, chief scientist of AMPS‑LLC, was part
of the discussing panel and an invited speaker to present provocative
aspects related to the role of device development and the FDA ECG
warehouse. His presentation slides in PDF format can be downloaded
here (please contact
marketing@amps-llc.com to
request the PowerPoint slides).
Version
1.6.2 of HeartScope is now available in the
download
area. New features include a new raw supported format, more in-depth
analysis, improved management of calibrated files and many other changes and fixes.
Implementing the HL7 XML Annotated ECG Waveform Standard
Bergamo,
Italy September 23rd, 2005
Building on the
success of last year, we will once again hold a workshop covering
the HL7 XML annotated ECG standard. New to this year’s program will
be a session covering recent developments with the FDA Warehouse,
including an in-depth review of its first release.
As of January 20th, 2004 the Annotated ECG (aECG) XML Waveform
Standard was finalized and formally adopted by the Health Level 7
(HL7) standards organization. HL7's adoption of the aECG XML
Waveform Standard was the culmination of an effort initiated in
November of 2001 by the US Food and Drug Administration (FDA) to
enable submission of digital aECGs to establish the cardiac safety
of new drugs. The final aECG Waveform Standard was authored through
an ad hoc group consisting of representatives from sponsor
organizations, ECG core laboratories, academic institutions and
medical device companies.
With the standard finalized, sponsors and ECG core laboratories are
moving quickly forward to implement compliant solutions.As expected,
through these implementation activities, several questions regarding
the proper utilization of the aECG Waveform Standard have surfaced
including:
What needs to be
included in the annotated ECG XML files?
What file
structure needs to be used for individual aECGs?
What duration
requirements are there for the aECGs?
What vocabulary
can be used for the annotations?
How to ensure
proper adherence to the standard?
When will the
FDA begin using the ECG Warehouse and how will they use it?
In order to provide
answers to such implementation questions and other related issues,
AMPS, LLC and Mortara Instrument, Inc. are organizing a workshop
designed for representatives from sponsor organizations and ECG core
laboratories who are responsible for compliance with the new aECG
XML standard.
This one day workshop will feature presentations from two primary
authors of the aECG XML standard, Fabio Badilini of AMPS and Barry
Brown of Mortara Instrument. Included in the workshop materials will
be a thorough implementation guide for the aECG XML standard and one
AMPS XMLFDA Viewer Light software license. Attendance will be
strictly limited to encourage open exchange and discussion between
presenters and participants.
Hereis the
complete Workshop Agenda (.pdf format).
Tutorial:
Implementing the HL7 XML Annotated ECG Waveform Standard
As of January 20th,
2004 the Annotated ECG (aECG) XML Waveform Standard was finalized
and formally adopted by the Health Level 7 (HL7) standards
organization. HL7's adoption of the aECG XML Waveform Standard was
the culmination of an effort initiated in November of 2001 by the US
Food and Drug Administration (FDA) to enable submission of digital
aECGs to establish the cardiac safety of new drugs. The final aECG
Waveform Standard was authored through an ad hoc group consisting of
representatives from sponsor organizations, ECG core laboratories,
academic institutions and medical device companies.
With the standard
finalized, sponsors and ECG core laboratories are moving quickly
forward to implement compliant solutions. As expected, through
these implementation activities, several questions regarding the
proper utilization of the aECG Waveform Standard have surfaced
including:
What needs to be
included in the annotated ECG XML files?
What file
structure needs to be used for individual aECGs?
What duration
requirements are there for the aECGs?
What vocabulary
can be used for the annotations?
How to ensure
proper adherence to the standard?
In order to provide
answers to such implementation questions and other related issues,
AMPS, LLC offers a tutorial designed for sponsor organizations and
ECG core laboratories who are responsible for compliance with the
new aECG XML standard.
This one day
tutorial features presentations from one of the primary authors of
the aECG XML standard, Dr. Fabio Badilini of AMPS, and can be held
within the premises of your own organization.
The agenda of the
tutorial:
Introduction
Background
What is the
problem?
What is the
FDA requesting? Why?
Typical digital
ECG process in compliance with FDA guidance
What is a
digital ECG?
Collect/Manage/Annotate digital ECGs
Submit
digital ECGs to agency for review
HL7 and V3
Information Modelling
What is HL7?
What is V3?
HL7
information models
HL7’s aECG
Information Model
Implementation
Topics
Waveforms
Annotations
What to submit
to the FDA
Summary and
Wrap-up
Interactive Q&A
Session
Included in the
workshop materials is a thorough implementation guide for the aECG
XML standard.
To receive a pricing
proposition for the tutorial as well as dates availability please
send e-mail to
marketing@amps-llc.com
Version
3 of XMLFDA Viewer (freeware) is now available in the download
area.Full
review of the application according to the finalized version of theFDA/HL7 V.3 "Annotated
ECG" XML format balloted in Dec 2003.Full
review of the internal vocabulary according to the last version of MDCvocabulary (5c, Aril
2004).See
release notes for more details.
Version
2.0.6 of XMLFDA Viewer (freeware) is now available in the download
area. New features include a "digital toolbar", improved
user control of the grid, a dialog interface with currently available MDC
Vocabulary, and new horizontal and vertical scrollbars in the waveform
display window. See release notes for more details.
Version
2.6.0 of MSNA and TsdrPSD are now available in the download
area. New features include BRS calculation, transfer function, DB
support (only for MSNA), and many other changes and fixes.
A.M.P.S. Receives Food and
Drug Administration's Commissioner's Special Citation Awards for Important
Contributions in the ECG Waveform Standards Development
The Standard Will
Provide for Regulatory Submission of Annotated ECG Data to Help Meet the
FDA's Need to Assess the Cardiac Safety of New Drugs
The Commissioner of the
Food and Drug Administration has awarded a Special Citation to key
scientists at A.M.P.S. llc, eResearchTechnology Inc. (eRT), Mortara
Instrument Inc., and others for providing invaluable assistance to the FDA
for the development of a format for regulatory submission of digital
annotated electrocardiograms (ECGs). The format will be used by the FDA to
determine the cardiac safety of new drugs. The three companies have worked
in close collaboration over the past 2 years to develop a seamless digital
ECG solution for both standard 12-lead resting and 12-lead ECGs obtained
by Holter monitoring. The digital solution is the backbone of the central
ECG services offered to sponsors of clinical research to define the
cardiac safety of their new products. In recognition of this effort (along
with other contributors), Fabio Badilini of AMPS, Barry Brown of Mortara
and Joel Morganroth, M.D. of eRT each received the Special Citation Award.
Fabio
Badilini, the
founder of AMPS, has been instrumental in providing a free XML wave form
viewer to allow anyone to image the ECG with the annotations placed by the
central ECG laboratory and has also developed a full version software
allowing for organization, identification and specialized analyses of the
large volume of ECGs from clinical trials that will be submitted to the
FDA.
Joseph Esposito,
President and CEO of eRT, commented, "Dr. Joel Morganroth, our Chief
Scientist, has guided the development of the company's technology and
services that enable digital collection, measurement, interpretation,
reporting and storing of the digital ECGs that are used to define new drug
effects. eRT's technology, global operations and digital services,
together with the technology developed by Fabio Badilini at AMPS and the
state-of-the-art equipment from Mortara, has enabled us to provide the
best of class services to the drug development industry. This combination
of science, technology and collaboration positions eRT to offer franchise
agreements such as the ones recently announced, that provide for capacity,
compliance, and cost efficiencies. We are proud that the FDA has chosen to
recognize our Chief Scientist, who is a respected international expert in
the design and interpretation of ECG trials, for his contributions in this
area."
"Mortara is pleased
that it could provide its ECG technology expertise to facilitate the
development of this standard," commented Justin L. Mortara, Ph.D.,
Vice president of Mortara Instrument. "Mortara's involvement from the
initial concept to balloting of the standard within the HL7 organization
resulted in an open standard that can be easily utilized by medical device
companies, core laboratories, sponsors and the FDA. We are honored that
Barry Brown, our Product Integration Manager, was recognized for his
leadership role as the primary participant from the medical device
industry. As a leader in the field of ECG technology, Mortara is
encouraged by the digital initiative within FDA and the impact it will
certainly have on the accumulation of significant databases which in turn
will help the world better understand the nature of cardiac repolarization
and the safety of new drugs.
A.M.P.S. Receives Food and
Drug Administration's Commissioner's Special Citation Awards for Important
Contributions in the ECG Waveform Standards Development