June 25, 2013 – West Bend and Milwaukee, Wisconsin, USA –Spaulding Clinical Research, a change agent in the clinical research and medical device industries, announced it be will be partnering with Aurora Health Care to open a clinical research unit specifically for conducting early stage clinical trials. Aurora Health Care is the leading provider of health care services in Wisconsin and treats 1.2 million unique patients annually. The Aurora Research InstituteTMfocuses on research that transforms new discoveries into practical ways to improve patient outcomes.
The new research unit will be comprised of up to 18 patient rooms, treatment spaces, and a nursing station within one of Aurora’s teaching hospitals. The intentions of Spaulding and Aurora are to conduct Phase I and Phase II clinical studies. These studies, which may involve 10 to 100 volunteers, evaluate whether a new drug or device has the desired clinical activity. Such studies require careful management of participants and the use of high-precision pharmacokinetic measures.The Spaulding webECG™ mHealth solution leverages mobile off-the-shelf technology with customized applications to address protocol-driven care. The simplified design of the Spaulding Electrocardiograph makes use in the least expensive areas of treatment, with less skilled users and even patients, possible without sacrificing the diagnostic data that has become the standard for cardiovascular care, the 12-lead ECG. With an Open Systems architecture, interfaces to Electronic Health Records (EHRs), such as our Allscripts interface, are easily accomplished streamlining communication to the care team.
This partnership illustrates Spaulding Clinical’s on-going commitment to expanding its service offering, to better serve the pharmaceutical industry for the advancement of science and of medicine, and the Aurora Research Institute’sTMcommitment to improving patient care through advancing technologies. The collaboration is currently in the feasibility stage of acquiring an upcoming diabetes study with a top-five pharmaceutical company.
“Patient studies, especially those requiring an isolated clinical unit and a high degree of precision, are becoming increasingly important to determine the early efficacy of a new drug or device,” said Daniel Selness, general manager and senior vice president of operations at Spaulding Clinical. “Our ability to couple Spaulding’s industry-leading study execution with Aurora’s vast clinical expertise and extensive patient population make this a strong collaboration. Spaulding is pleased to be able to provide this added service for our study sponsors.”
Randall Lambrecht, PhD,Aurora’s senior vice president of research, said, “We focus on innovative research that improves patients’ quality of life. Our relationship with Spaulding is one more way Aurora is working to speed the development of new innovations to improve patient care.”
Spaulding Clinical selected Aurora for this collaboration due to Aurora’s proven outcomes with innovative clinical research and its commitment to providing high-quality health care. The Aurora Research InstituteTMincorporates leading-edge research, and evidence-based best practice into high-quality patient care. Aurora has a strong history of partnering with pharmaceutical companies, device manufacturers, contract research organizations, and government agencies and has more than 700 open research trials.
About Aurora Health Care
Aurora Health Care is a leading integrated not-for-profit health care provider in the Midwest United States serving communities throughout eastern Wisconsin and northern Illinois across its network of 15 hospitals and 172 clinics. Aurora cares for over 1.2 million unique patients annually with more than 1,500 employed physicians and 3,000 affiliated physicians. The Aurora Research InstituteTMcentralizes existing research endeavors at Aurora and opens the door for more studies, partnerships and collaborations. The institute houses research that transforms new discoveries into practical ways to improve patient outcomes. Aurora offers 700 clinical research projects, including over 400 clinical trials, more than any other organization in Wisconsin. Through this patient-centered research, Aurora gives patients access to more new drugs and devices than any other health care system in the state.
About Spaulding Clinical Research, LLC
Spaulding Clinical Research, LLC, a change agent in the clinical research and medical device industries, is focused on driving perpetual value for their clients through technology and process innovation that delivers speed, unprecedented quality and lower costs.
Spaulding Clinical Research operates a 105-bed clinical pharmacology unit with 96, 12-lead ECG, telemetry beds in West Bend, Wisconsin, USA. The facility is paperless, using a customized Phase I Electronic Data Capture system with bi-directional interfaces to clinical lab, bedside devices and telemetry. Spaulding Biometrics provides full-service biostatistics, data management and medical writing services.
As a Phase I-IV centralized cardiac safety provider, Spaulding Clinical offers project management, expert cardiologist ECG over-read and a complete suite of state-of-the-art equipment provisioning, including the cloud-based Spaulding webECG™ Management Solution with the purpose-built Spaulding Model 1000iQ Electrocardiograph.
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Aurora Health Care Media Contact
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