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Thursday, November 05 2009 11:50 |
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West Bend, WI, November 2, 2009 - Spaulding Clinical Research, a newly designed Phase I
Unit provisioned for all types of pharmaceutical trials including the most complex cardiac
safety studies, announces the recent completion of an 11-week, 240 subject thorough QT
study (TQT). Results were available for 99.63% of the total 17,280 ECGs required for the
study in real time throughout the study, and there was no ECG data loss, 99.85% of pre-
scheduled ECGs being successfully captured with high quality.
Spaulding Clinical has integrated the newest technology to automate the collection and
storage of virtually all data in a way the industry has not seen before. Paper records and
manual data entry have been virtually eliminated which; also eliminates human errors and
data loss. As a result the Spaulding Clinical staff spends more time in direct care of the
subjects.
The integration of modern technology and the resulting availability of most data in real-time
allows earlier identification of adverse events and earlier delivery of high quality data to the
Sponsor.
One of Spaulding Clinical’s innovations is the electronic integration of multiple data sources
with the ALPHADAS (Logos Technologies’ clinical trial platform). Tanna Kreigh, from
Logos, who has over 30 years of clinical trial experience, said, “I am amazed at how
thoroughly Spaulding Clinical staff has integrated data sources with our ALPHADAS
platform. In other phase I units I’ve observed near chaos on study days. However the staff at
Spaulding Clinical are incredibly confident and very efficient in their work. Things were so
well organized and executed I would never have known that it was a study day until I looked
at the monitors to see data coming in.”
Spaulding Clinical has now successfully recruited large numbers of study subjects and
quickly and efficiently completed several TQT studies and less complex pharmacokinetic
studies.
About Spaulding Clinical
Based near Milwaukee, WI, Spaulding Clinical Research (www.SpauldingClinical.com) is a
Phase 1 Clinical Research Unit and Cardiac Core Lab, offering a range of services including definitive QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect, and PK/PD characterization. Spaulding Clinical also offers a full suite of Cardiac Core Lab and over-reading services with state-of-the-art technology and cardiac expertise.
Contact:
Spaulding Clinical
Amanda Baltz
262.306.3324
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
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Thursday, November 05 2009 11:45 |
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West Bend, WI, November 2, 2009 - Spaulding Clinical Research, a newly designed
Phase I Unit provisioned for all types of pharmaceutical trials including the most
complex cardiac safety studies, announces that Ms. Chéri Barta has joined as the Senior
Director, Core ECG Lab Services.
Chéri has over 14 years of experience in Project Management and Business Development
at Covance Cardiac Safety Services and eResearch Technologies. While at Covance she
was a recipient of the Covance Way Award on behalf of the business unit for exceptional
leadership and client satisfaction in 2006, having been nominated six times – a first in the
history of the Company.
Chéri will be responsible for the management, development and implementation of the
strategic plans for the conduct of clinical trials by the ECG Core Lab with an emphasis on
Project Management, Data Management, Logistics and Client Support.
Spaulding Clinical is a Phase I Clinical Research Unit and Electrocardiography Core Lab
located in West Bend, Wisconsin offering a full range of services including thorough
QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and
bioequivalence, drug interaction, food effect studies, PK/PD characterization, and data
collection and management. Spaulding Clinical also offers a full suite of
Electrocardiography Core Lab and over-reading services with state-of-the-art technology
and cardiac expertise. The company’s website is www.spauldingclinical.com
Contact:
Spaulding Clinical
Amanda Baltz
262.306.3324
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
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Wednesday, July 01 2009 08:00 |
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July 2, 2009 ‐ Milwaukee, WI Tiba Medical and Spaulding Clinical Research announced today an important collaboration for supporting Phase I cardiac safety clinical trials.
As part of this strategic agreement, Spaulding Clinical Research has integrated Tiba Medical’s Ambulo 2400 ambulatory blood pressure monitoring (ABPM) systems into its suite of offerings. In this way, clinical trials that need to review blood pressure as a cardiac safety biomarker can now obtain, acquire, analyze, and report findings seamlessly. The ambulatory device and related software will greatly simplify and improve the frequent acquisition of blood pressure data in varying activity states. The completed solution will allow pharmaceutical companies and their Clinical Research Organization (CRO) partners to accomplish the following objectives:
- Design and manage a stringent protocol for cardiac safety monitoring using a state-of-the-art Clinical Trial Management System
- Obtain, analyze, review, and report critical clinical safety biomarkers - including blood pressure—for each subject in a Phase I environment
- Correlate ECG data (e.g., ST segment shifts) with blood pressure data at perfectly synchronized time points
- Perform chronologically precise correlations of physiological parameters (e.g., electrocardiographic QTc or blood pressure) with plasma concentration for PK/PD modeling
- Warehouse all data and provide near real-time results for review by sponsors and safety experts, and
- Utilize a solution that is validated and complies with the FDA’s 21 CFR Part 11 criteria for electronic records
"In our continuing pursuit to move the science of cardiac safety studies into the 21st century, it is important to offer our clients the ability to collect blood pressure as an added cardiac safety biomarker," said Randy Spaulding, founder of Spaulding Clinical Research. "By incorporating Tiba Medical's ABPM systems, we are able to offer our clients a state-of-the-art solution that seamlessly integrates with our overall services."
"The FDA and other regulatory agencies are continually assessing various biomarkers and surrogates as part of the risk/benefit evaluation of new drugs. Changes in blood pressure induced by new drugs are now recognized as an important consideration for increased cardiovascular risk" said Merat Bagha, President and Chief Executive Officer of Tiba Medical. "We are pleased to partner with Spaulding Clinical Research to provide a seamless, integrated, and ready-to-go platform for better assessing cardiac safety" said Mr. Bagha.
The combined solution will be available directly from Spaulding Clinical Research to biopharmaceutical customers and their CRO partners in July 2009.
About Spaulding Clinical
Based near Milwaukee, WI, Spaulding Clinical Research (www.SpauldingClinical.com) Spaulding Clinical is Phase 1 Clinical Research Unit and Cardiac Core Lab and offer a range of services including definitive QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect, PK/PD characterization and data collection and management. Spaulding Clinical also offers a full suite of Cardiac Core Lab and Over-reading services with state-of-the-art technology and cardiac expertise.
About Tiba Medical
Based in Portland, Oregon, Tiba Medical offers innovative and affordable hypertension diagnostics solutions. Tiba Medical is an FDA-registered establishment and certified to be compliant with the ISO 13485:2003, acknowledging that Tiba Medical meets quality system requirements that are recognized across the world. For more information about Tiba Medical and its products please visit their web site at www.tibamedical.com.
Contacts
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Wednesday, March 18 2009 00:00 |
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Collaboration Includes Development and Validation of Automatic ECG Analysis Tools for use in Clinical Trials
Milwaukee, WI - March 9, 2009 —Spaulding Clinical Research, a next generation Clinical Research Unit designed from the ground up for Cardiac Safety studies, announced today a strategic agreement with Mortara Instrument. As part of the agreement, both companies shall collaborate on the design, implementation and verification of new ECG acquisition, analysis and report generating technologies for clinical testing of new drugs.
Major elements of this cooperation include:
- Full system integration of electrocardiographic data and its analysis
- Clinical testing and validation of new 12-lead wireless ECG technologies
- Collaboration with Mortara engineers on new automatic ECG analysis algorithms
- Detailed clinical workflow analysis during execution of a drug study
- ECG Data management technologies for smooth transition of data to sponsors
- Secure web reporting techniques for near real-time results review
- Collaboration on promising new biomarkers for cardiac risk
"Our collaboration with Mortara helps us achieve the goal for which Spaulding Clinical Research was founded: to move the science of Phase I Cardiac Safety studies into the 21st century," said Randy Spaulding, founder of Spaulding Clinical Research. "Phase I Clinical Research Units have a profound responsibility to the Sponsors of new drugs and, ultimately, to the general public to provide extremely accurate and reliable assessment of cardiac risk. This requires better technologies. The technical and clinical ECG experience of Mortara Instrument and Spaulding Clinical Research is collectively in the hundreds of years. Why not combine the best minds in the industry for the benefit of cardiac safety?"
Spaulding is uniquely specialized to conduct Cardiac Safety Testing for new drugs in development. Spaulding provides the highest in quality clinical trial conduct, using the most efficient processes in the industry.
Justin L. Mortara, Ph.D., CEO of Mortara Instrument commented, "Working closely with Spaulding Clinical Research provides Mortara with an excellent Phase I environment to further enhance and develop our new ideas in ECG acquisition and automated workflow. Coupling our premier digital ECG collection platform with Spaulding Clinical’s hands on knowledge and experience is a promising combination."
About Spaulding Clinical
Based near Milwaukee, WI, Spaulding Clinical Research (www.SpauldingClinical.com) Spaulding Clinical is Phase 1 Clinical Research Unit and Cardiac Core Lab and offer a range of services including definitive QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect, PK/PD characterization and data collection and management. Spaulding Clinical also offers a full suite of Cardiac Core Lab and Over-reading services with state-of-the-art technology and cardiac expertise.
About Mortara Instrument
Based in Milwaukee, WI, Mortara Instrument, Inc. 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, data warehousing solutions, and cardiology monitoring systems. The company’s website is www.mortara.com.
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Tuesday, March 17 2009 00:00 |
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Washington DC, - March 18, 2009 — At the 110th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Spaulding Clinical and MMS Holdings Inc. announced a strategic partnership to promote an integrated suite of advanced technologies and services to optimize Phase 1 study support.
This alliance will facilitate comprehensive study design, synopsis/protocol authoring, study execution, data management, statistical programming and analysis, and Clinical Study Report interpretation and writing – all integrated in one seamless electronic data flow. This means that Sponsors do not have to pay for costly and error-prone data transfers but instead work with one vendor and one source of study data for all their study needs. Additionally, this fully integrated approach enables Spaulding to analyze study data in real-time, providing invaluable quality control feedback for immediate correction - while the subjects are still being monitored.
Spaulding Clinical is a Phase 1 clinical trial facility with state-of-the-art services utilizing the most advanced technologies available to monitor, record, analyze and report trial data. With our unique specialization in cardiac safety testing for new drugs in development, Spaulding Clinical provides the highest quality clinical trial conduct—using the most efficient processes in the industry—resulting in the most accurate data possible.
“We are very excited to add MMS Holding’s Inc. capabilities to our comprehensive list of Phase 1 services,” noted Daniel Selness, Vice President of Operations, Spaulding Clinical. “As a robust clinical service provider, MMS Holdings Inc. is built on a strong foundation of science and quality and has a proven track record of delivering strong results for their clients. They are uniquely positioned to support Sponsors in data analyses, medical writing and overall development. Their expertise in regulatory requirements and submissions creates a high value to this partnership, keeping in mind the end-goal of a successful regulatory submission for our clients.”
“This partnership represents a significant milestone for us,” said Uma Sharma, Chief Scientific Officer for MMS Holdings Inc. “Spaulding Clinical shares our commitment to scientific excellence and innovative solutions. Well-planned and well-conducted phase 1 trials, especially in the area of cardiac safety, are of great importance to our clients and to regulators, and Spaulding Clinical provides the necessary scientific, operational and technological expertise in this area. We are very impressed with the Spaulding team and our combined strengths will bring increased value and high quality results to our clients; who in turn can deliver promising medications to patients who need them.”
About Spaulding Clinical
Spaulding Clinical is Phase 1 Clinical Research Unit and Cardiac Core Lab located in West Bend Wisconsin. Spaulding Clinical offers a range of services including definitive QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect, PK/PD characterization and data collection and management. Spaulding Clinical also offers a full suite of Cardiac Core Lab and Over-reading services with state-of-the-art technology and cardiac expertise.
Contact:
Spaulding Clinical
Amanda Baltz
262.306.3324
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
Spaulding Clinical
525 S. Silverbrook Drive
West Bend, WI 53095
USA
www.spauldingclinical.com
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001 certified for all services and maintains detailed quality metrics for every project.
Contact:
MMS Holdings Inc
Kelly J. Hill
734.245.0344
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
MMS Holdings Inc
6880 Commerce Boulevard
Canton, MI 48187
USA
www.mmsholdings.com
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