A Medical Device Daily

etrials Worldwide (Morrisville, North Carolina), a provider of eClinical solutions, and Ockham Development Group, a global contract and research and development organization and a subsidiary of ASG (both Cary, North Carolina), have entered into a five-year technology transfer agreement, which enables Ockham to provide its customers with etrials' Trial Intelligence electronic data capture (EDC) solutions.

Under etrials' CRO Partnership Solutions program, the five-year in-licensing agreement allows Ockham to offer its sponsor customers a more comprehensive suite of eClinical capabilities for aggregating, monitoring and analyzing data with the ability to develop and deploy studies on their own.

According to the organizations, Ockham will be self-sufficient in terms of developing and deploying studies using etrials' EDC solutions, and etrials will provide best practices, training, hosting, development, technical, as well as sales and marketing support.

"This joint venture further allows ASG and Ockham to expand our service capabilities and better serve sponsors," said Ockham President Dr. Joshua Baker, who leads clinical operations for the group. "The addition of etrials' adaptive solutions to Ockham's offering portfolio increases our ability to provide an even greater breadth of integrated solutions with a highly flexible, robust EDC system delivered directly from us."

"This agreement gives ASG and Ockham the opportunity to transfer etrials' knowledge of EDC design and deployment best practices and support and meet their sponsors' clinical trial development requirements more holistically," said Denis Connaghan, etrials' president/CEO. "At the same time, etrials' EDC solution will serve a wider sponsor base."

etrials provides eClinical software and services to pharmaceutical, biotechnology, and medical device companies, as well as contract research organizations, offering adaptive, Web-based tools that work together to coordinate data capture, logistics, patient interaction and trial management – turning data into intelligence and shortening the pathway to an actionable study endpoint.

ASG provides contract research, functional outsourcing, and specialty staffing services to CROs, pharmaceutical, biotech and medical device companies that require clinical operations, GCP, GLP or GMP auditing, data management, statistical programming, biostatistics and medical writing solutions. Ockham, a subsidiary of ASG, is a privately held contract drug development.

In other agreements/contracts:

• Toshiba America Medical Systems (Tustin, California) said it has launched the new InTouch Flex Service agreement, offering its customers "unparalleled flexibility, security and value." According to Toshiba, the agreement is considered the first of its kind in the diagnostic imaging industry, and allows customers to secure fixed price points for both the full service and partnership agreements at the point of purchase and after the warranty, convert the agreement back and forth between a full service security agreement and a partnership agreement, as needed. This flexible service approach enables customers to adapt service plans throughout the lifetime of the agreement to match real-time needs, Toshiba said.

As the service needs of hospitals, IDNs and imaging centers change over time, Toshiba's InTouch agreement enables these facilities to adjust their service agreement to meet these needs, the company noted. The agreement allows customers to switch between the following existing full service and partnership agreements: InTouch full security agreement, which provides full protection for imaging systems, risk-free and fixed-price support, customized service solutions and technical support; or InTouch partnership agreement, a shared-risk solution allowing the customer to adjust service levels to optimize patient care while controlling costs, according to Toshiba.

• PHNS (Dallas) reported that Legacy Hospital Partners (LHP; Plano, Texas) has entered into a 10-year agreement for PHNS to provide information technology (IT) services and to deploy system-wide clinical, electronic medical record and financial applications for LHP and its hospitals. LHP is a privately held hospital company that owns, operates and manages acute care hospitals in small cities and in select urban markets throughout the U.S. through joint ventures with not-for-profit hospitals. PHNS will begin providing IT and application implementation services to Portneuf Medical Center (Pocatello, Idaho), an acute care hospital with 250 licensed beds that is owned by a joint venture between LHP and the Portneuf Health Care Foundation, which owns and governs Portneuf Medical Center.

• Premier Purchasing Partners (San Diego) reported new agreements for patient bedside products have been awarded to Medical Action Industries (Hauppauge, New York); Medline Industries (Mundelein, Illinois); and Vernacare (Toronto).

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

• Agilent Technologies (Santa Clara, California) and Anderson Forschung Group (AFG; Washington) reported a collaboration to develop quantitative peptide assays to speed protein biomarker discovery and validation.

The collaboration will combine AFG's stable isotope standards and capture by anti-peptide antibodies (SISCAPA) technology with Agilent's 1200 Series HPLC-Chip and 6400 Series triple quadrupole mass spectrometers (MS), the companies said. The combination will be used to develop methods for measuring the amounts of large numbers of peptides in digests of complex samples such as plasma. The results will benefit both organizations, and financial details were not disclosed.

The SISCAPA method utilizes antibody-coated magnetic beads and a rotary magnetic bead trap device to capture target peptides, which are then measured using a nanoflow LC-MS/MS system. The goal is to accurately measure the quantities of very small amounts of peptides in sample digests, creating a useful research tool with potential uses in advanced diagnostics.

The Agilent 1200 Series HPLC-Chip/MS system is a microfluidic platform that integrates LC columns, connection capillaries, and nanospray emitter in a polymer chip, providing uncompromised chromatographic performance, even with small sample input amounts. The credit card-sized device is inserted into Agilent's HPLC-Chip Cube to interface with the MS. Chip loading, solvent and sample delivery, high pressure switching of flows, and chip positioning in the MS source are all automated.

The Agilent 6400 Series triple quadrupole LC/MS systems can provide femtogram-level sensitivity across a broad mass range. These instruments have earned a reputation for reliably quantitating trace organic compounds in complex matrices, such as drug metabolites, herbicide levels in food and contaminants in ground water.