A Medical Device Daily

eResearchTechnology (ERT; Philadelphia) and Integrium (Tustin, California) reported their alliance to provide integrated Cardiac Safety and Ambulatory Blood Pressure Monitoring centralized core laboratory services to clinical trial sponsors and managers worldwide.

ERT provides centralized electrocardiographic, eClinical technology, ePRO, and other services to the biopharmaceutical, medical device, and related industries. Integrium is a cardiovascular and metabolic focused clinical research organization offering clinical development services, including Ambulatory Blood Pressure Monitoring (ABPM) centralized core laboratory services.

"This alliance addresses a growing need in clinical research to offer comprehensive, best in class services in these two closely related areas of clinical study," said Michael McKelvey, president/CEO of ERT. "While many sponsors recognize and source each company for its respective area of expertise, customers increasingly seek consolidation and streamlining in all phases of a clinical trial. ERT and Integrium approach the market in the same way – focusing on scientific excellence, providing a quality product, and client satisfaction. We are both metrics driven and process oriented to ensure on-time, on-budget, reliable data delivery on a global scale."

ERT and Integrium will deliver a combined solution to meet the increased demand for centralized cardiac safety and ABPM services during clinical trials. The partnership will offer integrated services from project planning and set-up through study conduct, management, and data delivery for primary and secondary cardiac clinical trial endpoints.

Integrium said it would provide a full range of ABPM supporting services to include robust and reliable equipment, analysis software, global on-demand 24/7 attended call center and scientific leadership. ERT will perform digital collection, measurement, interpretation, review, and distribution of cardiac safety data through its EXPERT 2.0 workflow-enabled data management system.

"Clinical trial sponsors have a strategic need to deliver accurate, cost-effective results in less time. They need therapeutic specialists with expertise they can trust. This partnership leverages the world's most advanced cardiovascular specific technologies and clinical research specific services from each company into one unified source, reducing costs and accelerating time to market for our Sponsors," said David Smith, MD, co-founder and chief medical officer of Integrium.

In other agreements/contracts news:

• First Coast Service Options (FCSO; Jacksonville, Florida), a fee-for-service Medicare administrator, said it is prepared to implement the first two phases of the new Medicare administrative contract the company was awarded by the Centers for Medicare and Medicaid Services last September. The Florida Part B segment of FCSO's new contract was implemented on Sunday and the Florida Part A segment will be implemented on Feb. 13. The remaining phases of the contract involve Puerto Rico and the U.S. Virgin Islands and will be implemented on March 1.

With these initial implementations, FCSO will be responsible for processing Florida Medicare Part A and B claims and performing other claim-related administrative services.

According to FCSO, since it has served as the primary fee-for-service Medicare contractor in Florida for over a decade, these implementations will largely mean "business as usual" for Florida's health care providers.

There are, however, several transition-related changes, primarily concerning payment policies and electronic claim filing procedures and formats, which will be implemented as part of the new contract. FCSO said it has communicated these changes extensively, using a variety of outreach and educational processes, to ensure Florida's provider community understands them and is ready. FCSO's contact information will remain the same for providers following these February cutover dates.

• Affiliated Computer Services (ACS; Dallas) said it has renewed its information technology (IT) outsourcing contract, valued at $26 million over three years, with the Queen's Health System (Honolulu).

Since 2001, ACS has been providing a range of IT application and technology infrastructure services to the Queen's Medical Center (also Honolulu), which is the largest private hospital in Hawaii and an affiliate of The Queen's Health System. ACS will continue IT support services for the medical center and other Queen's Health System affiliates.

ACS' healthcare provider IT outsourcing team provides help desk, desktop management and data center services, which encompass network, midrange and mainframe computer services. ACS is also providing security services to assist Queen's in meeting stringent regulatory and business requirements.

• Click Commerce (Beaverton, Oregon), an ITW company, reported that the University of South Florida (USF; Tampa) will use its eResearch Portal to fully automate Institutional Review Board (IRB) processes for human subject research. The goal is to deliver a seamless e-research administration environment encompassing a wide range of research funding and compliance processes by 2011, Click said.

• i2Telecom International (Atlanta), a developer of mobile applications and services, said it has agreed to host DiamondPhone's Internet telephony application, which is targeted towards the medical office community.

DiamondPhone connects single- and multi-office business users to a highly robust feature set that is tailored to medical office users. According to the company, one of the primary value drivers for DiamondPhone involves the ability to execute phone-based prescriptions between physician offices and pharmacies, thereby eliminating the need for traditional paper prescriptions.

• Norton Healthcare (Louisville, Kentucky) and Unibased Systems Architecture (USA; Chesterfield, Missouri) have finalized an enterprise-wide agreement for pre-visit access management, scheduling, physician portal, healthcare consumer portal and business intelligence software system and services referred to as ForSite2020. The contract includes Norton's five hospitals totaling 1,857 licensed beds in Kentucky.

• Premier Purchasing Partners (San Diego) reported new agreements for perfusion products have been awarded to Edwards Lifesciences (Irvine, California); Sorin Group USA (Arvada, Colorado); and Terumo Cardiovascular Systems (Ann Arbor, Michigan).

Effective Feb. 1, the 36-month agreements are available to acute care and continuum of care members of the Premier healthcare alliance.

Premier also reported new agreements for magnetic MRI compatible monitoring devices have been awarded to Invivo (Orlando, Florida), and Medrad (Warrendale, Pennsylvania).

Effective Jan. 1, the 36-month agreements are available to acute and continuum of care members of the Premier healthcare alliance.

• Mirna Therapeutics (Austin, Texas), a subsidiary of Asuragen, and the University of Texas M. D. Anderson Cancer Center Science Park Research Center (Smithville, Texas) have entered a collaboration to investigate microRNAs in human prostate cancer. The principal investigators for the study are Dean Tang, MD, PhD, associate professor in the division of carcinogenesis and adjunct associate professor in the College of Pharmacy, The University of Texas and David Brown, PhD, director of discovery, from Mirna.

According to Mrina, Tang has been a pioneer in identifying and characterizing prostate cancer stem cells and evaluating their role in the initiation, progression, and metastasis of human prostate cancer. Tang is actively pursuing therapeutic strategies for inducing senescence and apoptosis in prostate cancer stem cells.

Brown brings several years' experience developing technologies for the isolation, detection, and functional characterization of small RNA including microRNAs (miRNAs), the company noted. He has been applying these technologies at Mirna and Asuragen to identify miRNAs as diagnostic and therapeutic targets in human diseases, particularly cancer.

Asuragen is a diagnostic company and molecular biology service provider, focused on molecular oncology and genetic diseases, with emphasis on miRNA.

• WaveMark (Littleton, Massachusetts), a provider of real-time inventory management (RTIM) solutions for high value medical products, said its clinical inventory management solution, WaveMark CIMS, has been awarded a contract by MedAssets Supply Chain Systems (Alpharetta, Georgia), a group purchasing organization, as a solution for customer hospitals and hospital networks to manage high value, specialty inventory.

• Omnicell (Mountain View, California), a provider of system solutions to acute healthcare facilities, said it has been awarded five-year contracts by Duke University Health System (Durham, North Carolina) and Emory Healthcare (Atlanta) for Omnicell medication point-of-use and central pharmacy automation solutions.

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