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Monday, August 16 2010 00:00 |
 Spaulding Clinical to Commemorate Completion of 2nd Floor Renovation with West Bend Chamber of Commerce on Tuesday, August 24th
Additional space expected to bring more jobs, business to the West Bend areaAugust 16, 2010 - WEST BEND, WI - Spaulding Clinical Research, a Phase 1 Clinical Pharmacology Research Unit and Core ECG Lab, announced today that renovation of the clinic's second floor will be completed on Aug. 20. The newly-remodeled floor will make an additional 16,700 square footage of space available for use in future clinical studies. The opening will be celebrated at a ribbon-cutting ceremony with the West Bend Area Chamber of Commerce at 2 p.m. on Aug. 24 at Spaulding Clinical's facility in West Bend. Spaulding Clinical currently conducts its centralized cardiac safety studies on the third floor of its facility, which consists of 48 fully functional telemetry beds. The opening of the second floor will increase Spaulding's telemetry capacity to 96 beds, making the company the largest telemetry site in the world. The company's overall operational capacity will increase to 105 beds. "Since we opened our doors in 2008 we have had plans to expand our operations to the second floor of our facility," said Randy Spaulding, founder and CEO of Spaulding Clinical. "This renovation doubles our capacity for conducting safe, effective clinical trials that are supported by the best technology available. Ultimately, the renovation will help us continue to fulfill our mission, which is empowering the development of safe drugs that will save lives." The increase in operating capacity at Spaulding Clinical will help the company continue to attract additional major pharmaceutical companies to West Bend for their clinical trial needs, which will bring thousands of study volunteers to the local area. Through a partnership with the West Bend Area Chamber of Commerce and various local businesses, study volunteers will leave Spaulding Clinical with a packet of coupons - along with their significant stipends - that can be used at local establishments before they leave town. Spaulding Clinical estimates that volunteer stipends will reach $2 million for 2010. The opening of the second floor will bring dozens of new jobs to the West Bend community. "In the past two years, our company has grown from four employees to 92," said Daniel Selness, vice president of clinical operations at Spaulding Clinical. "With the addition of the second floor into our business operations, the number will only continue to grow as we will be able to open at least 25 new positions in the coming months. These positions will be made available to highly-trained, qualified individuals within the West Bend community and its neighboring communities." Kristine M. Deiss, mayor of the city of West Bend believes Spaulding Clinical is establishing itself as a major company and sees good things coming from its expansion. "I am thrilled to see that Spaulding Clinical has reached the point that they are able to expand their business," said Deiss. "This certainly bodes well for the community by increasing job opportunities and introducing more and more study volunteers to the amenities West Bend has to offer." Speaking for the local angel investors providing the seed capital for the venture, John Torinus Jr. said, "This is exactly the kind of growth we were hoping for when we wrote our checks. Actually, Spaulding is exceeding our expectations." In addition to the ribbon cutting, an open house of the second floor will be held at the company's facility on Saturday, Aug. 28, from 10 a.m. to 1 p.m. The open house will be for the public to learn more about Spaulding Clinical. Additionally, Spaulding will have a memory book set up for West Bend residents to share any and all memories of the old hospital. All of the work for the second floor renovation will be completed by local contractors from the West Bend community. The second floor renovation project has been financed by the M&I Bank of Milwaukee. For a free video tour of Spaulding Clinical, please visit http://www.spauldingclinical.com/overview/. About Spaulding Clinical
Spaulding Clinical ( www.spauldingclinical.com) is a Phase 1 Clinical Pharmacology Research Unit and Electrocardiography Core Lab located in West Bend, Wisconsin offering a full range of services. The company has extensive experience conducting TQT studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, and food effect studies. Spaulding Clinical also offers a full suite of Electrocardiography Core Lab and over-reading services with state-of-the-art technology, equipment and cardiac safety expertise. Spaulding Clinical Contact:
Amanda Baltz Sr. Director, Business Operations and Development 262.306.3324
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Monday, June 14 2010 00:00 |
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June 14, 2010 - WEST BEND, WI. – Spaulding Clinical Research, a Phase I Unit and Core ECG Lab announced today that it has been awarded its first Phase III centralized cardiac safety studies from an international biotech company. The award includes two studies with approximately 100 sites in multiple countries. Both studies require immediate start-up of ECG services.
Spaulding Clinical began conducting Phase I studies in 2009, and to date has managed numerous studies in their Phase I Unit that include centralized cardiac safety, but these are the first two studies that encompass a late stage, multi-site service offering.
Dr. Jay Mason, Spaulding Clinical CMO, stated, “Spaulding was awarded these Phase III contracts very shortly after its announcement of Phase III Core ECG Lab capabilities, because of the ability to respond to an unusually urgent time line at a unusually competitive price – both the result of our system’s simplicity and efficiency, and byproducts of the advanced, integrative technology we are using. Because FDA and Pharma are focusing progressively greater attention on the cardiac safety of new drugs, the role of electocardiography has increased substantially, and, along with it, the need for ECG information systems that cost less, are easier to use and provide more data of higher quality. The Spaulding ECG Core Laboratory is a novel ECG information system that has fully discarded the expensive, inefficient methods in use today and replaced them with a purpose-built solution that is naturally economical, simple to deploy and much more informative.”
Spaulding Clinical is launching its new business unit, ECG Information Solutions at the DIA meeting June 13 -16. Utilizing a novel approach, Spaulding Clinical will educate the industry on the methodology behind its new business unit, which is driven by a proprietary palm-sized ECG acquisition device, over the coming months.
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 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.
About Spaulding Clinical
Spaulding Clinical (www.spauldingclinical.com) is a Phase I Clinical Research Unit and Electrocardiography Core Lab located in West Bend, Wisconsin offering a full range of services including 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.
Spaulding Clinical Contact:
Amanda Baltz
Sr. Director, Business Operations and Development
262.306.3324
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
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Thursday, June 10 2010 00:00 |
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Offers Automatic Transfers of Spaulding Clinical Phase I Data into Medidata Rave EDC/CDM System
NEW YORK, N.Y. and WEST BEND, WI. – June 10, 2010 – Leading SaaS-based clinical technology solutions provider Medidata Solutions (NASDAQ: MDSO), and leading-edge Phase I and Cardiac Core Lab provider Spaulding Clinical Research today announced the availability of a data integration between Spaulding Clinical’s Phase I unit and the Medidata Rave® system for electronic data capture, management and reporting for all phases of clinical trials. Leveraging the Medidata Rave Web Services API (application programming interface), the solution enables data collected in Spaulding’s Phase I unit, including clinical data, laboratory data and data collected via electronic monitoring devices, to be automatically transferred into Medidata Rave.
Sponsors of clinical research using both Medidata Rave for electronic data capture (EDC) and clinical data management (CDM) and Spaulding Clinical’s Phase I unit benefit from automatic, real-time data transfers into Rave, eliminating the need to reconcile mismatched data that has been entered into multiple systems and providing up-to-the-minute views of trial progress and results.
“In working with our joint customers, it has become quite evident to us that an enormous value-add would be to provide automatic data transfers of comprehensive Phase I data into Medidata Rave, so that sponsors can view, manage and report on their data in the platform they have already chosen for EDC/CDM: Medidata Rave,” said Brock Heinz, Systems Integration Engineer at Spaulding Clinical. “We are excited to partner with Medidata Solutions to offer customers the ability to streamline Phase I trials by using their chosen platform in Phase I as well, so that they can manage and report on all their trials with the same optimized business processes.”
“We are excited to offer customers this innovative integration, which leverages industry standards to expedite data sharing across clinical technologies,” said Anne Zielinski, vice president of Alliances, Medidata Solutions. ”Spaulding Clinical has an innovative and technologically savvy approach to conducting Phase I trials, and our joint integration goes a long way to help customers realize the value of using market- leading technologies in Phase I trials.”
The Medidata–Spaulding Clinical integration also marks Spaulding Clinical’s membership into the Medidata Technology Partner Program, which recognizes technology providers, contract research organizations and other organizations that have clinical solutions integrated with Medidata products. Since its introduction in June of 2009, the Medidata Technology Partner Program has grown to include nine organizations that offer solutions supporting data sharing with Medidata products in order to streamline and enhance the end-to-end e-Clinical process.
About Spaulding Clinical
Spaulding Clinical (www.spauldingclinical.com) is a Phase I Clinical Research Unit and Electrocardiography Core Lab located in West Bend, Wisconsin offering a full range of services including 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.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical technology solutions that enhance the efficiency of customers’ clinical development processes and optimize their research and development investments. Medidata products and services allow customers to achieve clinical results more efficiently and effectively by streamlining the design, planning and management of key aspects of the clinical development process, including protocol development (Medidata Designer®), investigator benchmarking and budgeting (Medidata Grants Manager®), contract research organization (CRO) benchmarking and budgeting (Medidata CRO Contractor®), and the capture, management, analysis and reporting of clinical trial data (Medidata Rave®). Medidata’s diverse customer base spans pharmaceutical, biotechnology and medical device companies, academic institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies.
Spaulding Clinical Contact:
Amanda Baltz
Sr. Director, Business Operations and Development
262.306.3324
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
Medidata Contact:
Susan McCarron Lois
Paul & Partners
781.782.5767
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
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Monday, March 08 2010 00:00 |
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West Bend, WI, March 8, 2010 - Spaulding Clinical Research, a new Phase I Unit designed for all types of pharmaceutical trials, including the most complex cardiac safety studies, announced today that it will serve as both the Phase I clinical site and the Core ECG Laboratory for an upcoming Thorough QTc (TQT) study from one of the world’s largest pharmaceutical companies. This Sponsor has already completed clinical pharmacology work with Spaulding Clinical and has deemed Spaulding more than capable of executing complex studies.
Spaulding Clinical has now successfully completed several TQT and less complex pharmacokinetic studies. Many of these studies included both Phase I Clinical Pharmacology and centralized cardiac safety services.
Spaulding Clinical CEO and Founder, Randy Spaulding said, “We are extremely proud of this award because it demonstrates the ultimate customer compliment: repeat business. Indeed, our study quality has proven to significantly exceed Sponsor expectations. Spaulding Clinical is truly redefining the quality standards for Phase I and centralized ECG services.”
Spaulding Clinical Chief Medical Officer, Dr. Jay Mason, added, “Our new unit has attracted attention not only because we can provide both a the full array of CRU servies and centralized ECG services, but in large part because all of our services are highly integrated electronically, resulting in efficiencies and error reduction that translate to more rapid study completion at a lower cost.”
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 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 spauldingclinical.com |
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Tuesday, January 19 2010 00:00 |
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West Bend, WI, January 19, 2010 -
Spaulding Clinical Research, a newly designed Phase I Clinical Research Unit designed for all types of pharmaceutical trials including the most complex cardiac safety studies, announces that Mr. Kevin Geno has joined Spaulding Clinical as the Vice President of Sales.
Kevin has over 11 years of sales experience working with Covance, Inc., calling on the pharmaceutical industry in both the Cardiac Safety and Clinical Pharmacology business arenas. For the past two years Kevin was a Strategic Partnership Director and previous to that was a Senior Director Business Development at Covance.
Kevin will be responsible for continuing to establish, maintain and grow sales of Phase I/Core ECG Lab services, along with managing and growing the sales team.
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 spauldingclinical.com
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