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eclinical movements news in brief

By Emilie Reymond, 27-Feb-2007

Related topics: Clinical Development, Data management

Outsourcing-Pharma tracks the latest eClinical movements, featuring LifeTree eClinical, Medidata, Fast Track Systems, etrials and Cogiteq.

LifeTree eClinical, a provider of clinical electronic data capture (EDC) headquartered in California, has secured a third contract with Stereotaxis, a developer of instruments to enhance the treatment of coronary artery disease.

 

 

 

Under the terms of the deal, Missouri-based Stereostaxis will use LifeTree's EDC solution to record clinical data for a six-month study involving 100 patients at five sites.

 

 

 

Stereotaxis, which has been using LifeTree's system since 2005, said the technology has enabled it to maintain "a very lean organization while increasing clinical trial output, improving accuracy and keeping monitoring costs at a minimum."

 

 

Last week also saw Finnish pharma company Orion choose Medidata's EDC technology for its clinical studies throughout Europe.

 

 

 

Orion plans to use the Medidata's solution – Rave – to eliminate paper-based clinical processes and expects all of the company's trials to be managed by Rave within the next few years.

 

 

 

The company conducted a year-long evaluation of five leading EDC providers and Orion said the selection of Medidata Rave was due to "its flexible implementation and knowledge transfer process as well as the ability to analyze data in real-time."

 

 

 

It is the second contract Medidata has secured in less than a week for its Rave technology. The company announced last week its partnership with Fast Track Systems, a provider of clinical trial design software and services.

 

 

 

The two firms have entered into a multi-year agreement to integrate Medidata's EDC technology with Fast Track's TrialSpace Designer (TSD) study design software.

 

 

 

It could give the firms a competitive edge in a market where study design and EDC study build have been traditionally thought of as separate services.

 

 

 

"The combination of TSD and Rave integrates these two previously separate activities and creates a seamless flow of information from initial study design through electronic case report form (eCRF) build and beyond," said the two firms.

 

 

 

Fast Track added that the combined solution will reduce costly inefficiencies and expand execution capacity by automating complex processes.

 

 

 

Meanwhile, etrials is to partner with Microsoft to offer software solutions to that provide global reach for conducting clinical trials.

 

 

 

The eclinical services provider and the software giant will offer wireless electronic patient reported outcome (ePRO) solution to contract research organisations (CROs) and pharmaceutical companies that is standardised globally on Microsoft Windows Mobile-enables devices.

 

 

 

etrials has been standardised on Microsoft platforms since 1999 and has since seen its adoption rate climb exponentially year over year.

 

 

 

The level of adaptability with ePRO devices is higher using the Windows Mobile platform, as sponsors increasingly select eClinical tools based on how effectively the tool can accompany the abilities, competency and lifestyle of particular patient groups. The standardisation on Windows Mobile grants etrials the ability to offer worldwide pharmaceutical clients and CRO partners increased flexibility and functionality with its wireless (and wired) software that caters to the patient population's characteristics, preferences and demographics.

 

 

 

Compared to other operating systems that eClinical providers use, Windows Mobile software is designed to accommodate various screen dimensions, the firm claims. The platform also allows for multiple applications to run simultaneously, unlike other operating systems used for ePRO tools.

 

 

 

In other eclinical news, Boston-based ePRO solutions provider Symfo has entered into a partnership with Cogiteq, a CRO specialised in ePRO validation, to provide sponsors with a combined validation solution for their clinical trials.

 

 

 

"Regulatory authorities strongly recommend that sponsors provide evidence on the validity of the measurement properties of a patient self-report instrument for the specific study protocol and patient population," said Serge Bodart, Symfo's Chief CEO.

 

 

 

"Migrating a PRO instrument from paper to an electronic diary format is a serious change that falls under this recommendation."

 

 

The objective of the collaboration is to be able to recommend to sponsors the correct amount of validation needed for their specific study protocol, said Cogiteq.

 

 

 

Bodart added that Symfo and Cogiteq will consult with study sponsors to demonstrate the methodological appropriateness of an ePRO instrument for their specific clinical trial needs.

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