Randy Spaulding Announced As 2012 United Way Campaign Chair

April 27, 2012 – West Bend, Wisconsin, USA – Randy Spaulding, Founder and CEO of Spaulding Clinical Research, will lead the 2012 United Way of Washington County campaign this fall. Randy has been a member of the Board of Directors for the past four years and actively involved in many community partnerships.

“I strongly believe in the United Way mission, and I am most impressed with the accountability that United Way provides with its funded program oversight,” states Spaulding. “Over the next two months 24 community volunteers will review and rate funded programs based on outcomes and results. In order to receive United Way funding, programs must demonstrate that they make a measurable difference.”

“I was a fund distribution volunteer two years ago and learned so much about services and needs in our community,” continued Spaulding. “My volunteer experience inspired me to accept my new role as campaign chair. After seeing the needs in our county first-hand, I am committed to setting the bar high again for this year’s campaign so we can support those that need our help the most.”

“We are extremely grateful and excited that Randy Spaulding is serving as our campaign chairman this year,” said Kristin Brandner, Executive Director of the United Way of Washington County. “Randy is a passionate, determined supporter and leader of United Way who is truly dedicated to his role as campaign chairman. His entrepreneurial spirit has already been effective as we look at new and creative ways to improve our campaign and build awareness about United Way.”

As one awareness building initiative, United Way is rolling out a new theme called Live United. “Live United are two very powerful words – think what we can do when we come together/united for the common good of our community,” explains Spaulding. “This is a positive message we hope will resonate with others and encourage involvement through giving, advocating and volunteering.”

Visit United Way’s new website at unitedwayofwashingtoncounty.org to learn about Live United, a photo contest to highlight this new theme, and information about agency programs United Way supports. To learn more about Spaulding Clinical Research, visit their website at spauldingclinical.com.

About United Way of Washington County
United Way of Washington County is an independent non-profit organization that raises funds for health and human service needs and responsibly distributes those funds to improve the quality of life in Washington County.

About Spaulding Clinical Research, LLC
Spaulding Clinical Research, LLC provides Clinical Pharmacology, Cardiac Core Lab clinical research services, and is a medical device manufacturer. Spaulding Clinical operates a 155-bed clinical pharmacology unit with 96-beds of telemetry in West Bend, Wisconsin, USA. The facility is paperless, with a Phase I Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry. As a Phase I-IV Core ECG Laboratory provider, Spaulding Clinical offers the complete suite of equipment provisioning and electrocardiograph over-reading services with state-of-the-art technologies, including the proprietary Spaulding iQ Electrocardiograph, and expertly-cardiologists and project managers.

Spaulding Clinical Media Contact
Kathy Forde
Sr. Director of Marketing
Tel:  (414) 303-1912
Email:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

United Way of Washington County Media Contact
Kristin Brandner
Executive Director
Tel:  (262) 338-3821
Email:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

Spaulding Clinical Growth Plan Results in $850,000 in Tax Credits

March 28, 2012 – West Bend, Wisconsin, USA – Governor Scott Walker visited Spaulding Clinical Research, LLC today to announce the company is eligible for up to $850,000 in tax credits through the Wisconsin Economic Development Corporation (WEDC) to facilitate the creation of 183 new full-time positions. “This investment by Spaulding reinforces Wisconsin as one of the leading states in the country in medical innovation,” said Governor Walker. “I am pleased to announce this support for Spaulding for the creation of quality jobs for Wisconsin workers.”

In Governor Walker’s announcement, which was made to a room full of state and local legislators, Spaulding Clinical investors and employees, as well as local media, he described Spaulding Clinical as “a beacon of medical technology.” He went on to highlight the significant investment Spaulding Clinical is making, which he recognized would have not only a local, but global impact.

Spaulding Clinical Research, LLC was established in 2007 by Founder and CEO, Randy Spaulding, to create a next generation clinical research organization, providing pharmaceutical sponsors higher quality data without sacrificing cost or timelines. Last year, he extended his vision with the launch of the Spaulding iQTM Electrocardiograph, a hand-held, mobile device designed for large global pharmaceutical clinical studies where cardiac safety assessments are required. This disruptive technology weighs only 3 ounces, records up to 5 minutes of ECG data compared to just 10 seconds from competitive products, and uses voice biometrics to identify the patient. “We are blessed to have a creative, dedicated and expert workforce at Spaulding Clinical and look forward to executing our growth plans which will provide more opportunities for quality jobs in Wisconsin,” states Randy Spaulding.

The employees who will be hired as a result of the tax credits will vary from skilled professionals in the medical industry to sales staff. Since January of this year, Spaulding has added 5 full-time hires and 10 part-time clinical staff. Spaulding Clinical projects that within three years they will surpass the 183 positions.

Spaulding Clinical received assistance from Economic Development Washington County (EDWC) in applying for WEDC tax credits. “We are a great example of the important role economic development plays to support small business growth and job creation. Our ability to move forward with our plans and deliver in a narrow market window is critical for us,” states Randy Spaulding. “The support from EDWC in coordination with WEDC allowed me to keep my focus on the business, which is so important to achieving our goals.”

Christian Tscheschlok, Executive Director of EDWC, says that support of Spaulding Clinical’s project has been a priority because it represents such a strong fit with EDWC’s focused strategy to fuel quality jobs and wealth. “Medical-technology is not just a buzz word for Washington County; rather, it represents an emerging industry with globally recognized companies growing right here,” Tscheschlok notes, “which is why EDWC not only collaborated with Spaulding and the State to secure State tax credits, but is also partnering with the city of West Bend to develop new financial tools to further accelerate Spaulding’s growth and success.”

Spaulding Clinical was ranked #3 in its space for Wisconsin’s Top 100 Places to Work in 2011. Additionally, Spaulding Clinical was ranked #1 in the space of “Direction” among all companies in the state of Wisconsin. Employees are fueled by the vision of the company and the core values which drive its performance. The key management team comes with over 200 years of collective experience in clinical research and healthcare.

About Economic Development Washington County
Economic Development Washington County (EDWC) is an independent economic development organization fueling growth businesses and industries for the creation of quality jobs and wealth in Washington County. EDWC accomplishes this through a focus on existing business development consulting; engaging in driver-industry business attraction; supporting qualified start-up enterprises and serving as a central voice on economic development issues.

About Spaulding Clinical Research, LLC
Spaulding Clinical Research, LLC (spauldingclinical.com) provides Clinical Pharmacology, Cardiac Core Lab clinical research services, and is a medical device manufacturer. Spaulding Clinical operates a 155-bed clinical pharmacology unit with 96-beds of telemetry in West Bend, Wisconsin, USA. The facility is paperless, with a Phase I Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry. As a Phase I-IV Core ECG Laboratory provider, Spaulding Clinical offers the complete suite of equipment provisioning and electrocardiograph over-reading services with state-of-the-art technologies, including the proprietary Spaulding iQ Electrocardiograph, and expertly-cardiologists and project managers.

Spaulding Clinical Media Contact
Kathy Forde
Sr. Director of Marketing
Tel:  (414) 303-1912
Email:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

EDWC Media Contact
Christian Tscheschlok
Executive Director, EDWC
Tel:  (262) 335-5769
Email:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

Spaulding Clinical Selects BioQT for use with the Spaulding IQ ECG System and Phase I Clinical Pharmacology Unit

March 15, 2012 – Abingdon, Oxfordshire, UK – OBS Medical Ltd., a patient monitoring and cardiac safety solutions developer, announced today that it has signed an agreement with Spaulding Clinical Research, LLC, based in West Bend, WI, USA, licensing the use of BioQTTM. Spaulding Clinical is the first Phase I Clinic and Cardiac Core Lab with the BioQTTM software suite installed onsite. BioQTTM has also been integrated as an option for use with the Spaulding IQTM electrocardiograph system to support Phase I through IV studies managed by Spaulding Clinical’s ECG Core Laboratory.

OBS Medical Ltd‘s installation of BioQTTM alongside the Spaulding IQTM System has delivered greater opportunities for pharmaceutical Sponsors to have access to fast and efficient data with accuracy and confidence that is synonymous with the BioQTTM product.

Spaulding Clinical selected BioQTTM after an assessment of other algorithms and believes it to be the best highly automated ECG analysis product available on the market today. During evaluation BioQTTM demonstrated the required accuracy, speed of analysis, cost savings and risk reduction that Spaulding Clinical customers require. OBS Medical’s Chief Executive Officer, Peter Leyland reported, “Spaulding Clinical is a leader in cardiac safety studies and has designed their service offering to deliver precise ECG data for clients assessing the cardiac safety profile of their molecule. The BioQT software enables even further analysis for their clients.” Spaulding Clinical’s General Manager and Senior Vice President of Operations Daniel Selness stated that “having the BioQT solution fully integrated into our ECG data collection and analysis stream, allows for our Cardiologists to detect the earliest possible T-wave morphology change or other electrophysiologic changes.”

OBS Medical’s BioQTTM software has led the way in highly automated ECG analysis for 12 Lead ECG recording devices and is the only analysis system that is trained to Cardiologist annotations. BioQTTM has been validated to demonstrate the ability to provide fast, accurate results for cardiac safety in accordance with ICH E14 Guidance for Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential and Non-Antiarrhythmic Drugs.

About BioQTTM Technology
BioQTTM is a patented innovative product which performs interval analysis of ECG waveforms in clinical trials, using Hidden Markov Models (HMM). The ECG waveforms are then divided into segments using the HMM, corresponding to the physiological events of the heart that are analysed. Through the use of HMM, BioQTTM can produce a confidence level on a beat by beat basis ensuring only good quality data is included in the analysis, thereby presenting highly accurate cardiac safety data while reducing the size of the studies required.

About OBS Medical Ltd.
OBS Medical (www.obsmedical.com) is a company which provides medical devices, clinical data analysis solutions and telehealth systems. The clinical products are BioQTTM, for ECG waveform analysis during drug development and mPRO, a mobile-phone based electronic patient reported outcome (ePRO) solution. Both products are committed to the improvement of drug development through the, minimising of risk, cost reduction and maximising efficiency.

About Spaulding Clinical
Spaulding Clinical Research, LLC (www.spauldingclinical.com) provides Clinical Pharmacology, Cardiac Core Lab clinical research services and is a medical device manufacturer. Spaulding Clinical operates a 155-bed clinical pharmacology unit with 96-beds of Mortara telemetry in West Bend, Wisconsin. The facility is paperless with a phase I Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry. As a Phase I-IV Core ECG Laboratory provider, Spaulding Clinical offers the complete suite of equipment provisioning and electrocardiograph over-reading services with state-of-the-art technologies, including the proprietary Spaulding iQTM Electrocardiograph, and expertly trained cardiologists and project managers.

Spaulding Clinical Media Contact
Kathy Forde
Sr. Director of Marketing
Tel:  (414) 303-1912
Email:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

Spaulding Clinical Announces Partnership with clinicalRSVP

March 12, 2012 – West Bend, Wisconsin, USA – Spaulding Clinical Research, LLC, a US-based leading-edge clinical pharmacology unit, cardiac core lab and medical device manufacturer, announced it be will be partnering with clinicalRSVP (clinical Research Subject Verification Program), the leading provider of participant registry services. This partnership illustrates Spaulding Clinical’s ongoing commitment to subject safety and data integrity.

Spaulding Clinical will join participating clinical sites that utilize clinicalRSVP to check subject eligibility requirements before dosing commences. Spaulding Clinical is the first site in the Midwest to join clinicalRSVP’s network, which includes sites located along both coasts. The addition of Spaulding Clinical expands the reach of the clinicalRSVP site network, and greatly strengthens the relevance of the network for participating sites.

clinicalRSVP was chosen by Spaulding Clinical as its preferred provider of dual enrollment protection services due to clinicalRSVP’s expansive network, proven track record, ease of operational implementation, and regulatory compliance. clinicalRSVP has years of experience in providing registry services; the company has developed a network of sites that currently includes more than 25 percent of all Phase I beds in North America.

“Dual enrollment is becoming an incredibly hot topic in the clinical pharmacology circuit as sponsors are becoming very keen to ensure subjects are only in their studies,” commented Daniel Selness, general manager & senior vice president of operations at Spaulding Clinical. “Spaulding is pleased to be able to provide this added measure of diligence for our study sponsors.”

“The addition of Spaulding Clinical represents a terrific advancement for clinicalRSVP and for those who sponsor and conduct Phase I clinical trials across North America,” said Darran Boyer, president of clinicalRSVP. “We are pleased that the network now spans from coast to coast, including the Midwest and into Canada. We see the continued growth of this Phase I network as a positive sign of things to come.”

clinicalRSVP (idi.clinicalRSVP.com) is the North American network that prevents research volunteers from enrolling in multiple research studies concurrently. This blinded cooperative registry allows investigators to confidentially and securely verify subject eligibility requirements prior to subject enrollment in clinical trials, resulting in advances to clinical research data integrity and participant safety.

Spaulding Clinical Research, LLC (www.spauldingclinical.com) provides clinical pharmacology and cardiac core lab clinical research services, and is a medical device manufacturer. Spaulding Clinical operates a 105-bed clinical pharmacology unit with 96 beds of telemetry in West Bend, Wisconsin, USA. As a Phase I-IV core ECG laboratory provider, Spaulding Clinical offers the complete suite of equipment provisioning and electrocardiograph over-reading services.

clinicalRSVP Media Contact
Lisa Rehberger
Director, Business Development
Tel:  (954) 918-9365
Email:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

Spaulding Clinical Media Contact
Kathy Forde
Sr. Director of Marketing
Tel:  (414) 303-1912
Email:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

Spaulding Clinical Announces Expansion into Europe

January 9, 2012 – West Bend, Wisconsin, USA – Spaulding Clinical Research, LLC., a US-based leading-edge Clinical Pharmacology, Cardiac Core Lab, and Medical Device Manufacturer, announces it has expanded its presence into Europe with the appointment of Katie Wessel to the newly created position of Manager of Business Development – Europe.

“As we continue to grow and form strategic partnerships with drug research companies around the world, we want to continue to expand and fortify a global presence for Spaulding Clinical,” states Randol Spaulding, Founder and CEO of Spaulding Clinical Research.  “With the appointment of Katie to this dedicated position in Europe, Spaulding Clinical is taking the next step toward becoming a truly global company.”

Katie has been with Spaulding Clinical since the company’s inception in 2007.  Previously, Katie held an Associate Director position and over the past four years she has been involved in several areas of business operations, including Sales, Clinical Operations, and Recruitment.

“Katie has been a key part of Spaulding Clinical’s success and we are excited for her to take on this new role,” said Kevin Geno, Vice President of Global Sales at Spaulding Clinical.  “Katie brings a wealth of talents to this new position, including the successful management of critical departments at Spaulding Clinical, an understanding of the company’s core systems and processes, and an extreme focus on the customer.”

In her new role, Katie will be responsible for overseeing all of Spaulding Clinical’s business development activities in Europe.

Spaulding Clinical Research, LLC (www.spauldingclinical.com) provides Clinical Pharmacology, Cardiac Core Lab clinical research services, and is a medical device manufacturer. Spaulding Clinical operates a 105-bed clinical pharmacology unit with 96-beds of telemetry in West Bend, Wisconsin, USA. The facility is paperless, with a Phase I Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry. As a Phase I-IV Core ECG Laboratory provider, Spaulding Clinical offers the complete suite of equipment provisioning and electrocardiograph over-reading services with state-of-the-art technologies, including the proprietary Spaulding iQ Electrocardiograph, and expertly trained cardiologists and project managers.

 

Spaulding Clinical Media Contact

Kathy Forde

Sr. Director of Marketing

Tel:  (414) 303-1912

Email:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it.