Perceptive Informatics' IMPACT Has Improved Global Capabilities
By Deborah Borfitz

Recent enhancements to IMPACT, the clinical trial management system (CTMS) of Perceptive Informatics, give study sponsors the flexibility they need to conduct increasingly larger, more global trials and introduce a new way for study monitors to get their job done.

A new online and offline Web-based site management and monitoring module, called MySites, is the most notable improvement to IMPACT (International Management Package for Administration of Clinical Trials), says Sina Adibi, vice president of software development and chief technology officer for Perceptive Informatics, Parexel's technology subsidiary. "Anything monitors can do when they're connected to the main database they can now do offline, at any time, from anywhere in the world. When they dock at MySites it automatically synchronizes everything they've entered offline into the online database. The integrity of the data is managed by the system for them."

Training is easier when users don't have to learn a separate set of instructions, depending on whether they are working online or offline, Adibi notes. The application offers a display of all sites for which a given user has responsibility. All information gathered at the time of a monitoring visit can be incorporated into an electronically-signed PDF, which can then be routed for review and approval.

IMPACT has also been given some new capabilities, says Adibi. These include the ability for more than one monitor to work on a trial visit simultaneously. For trial designers, there is now recognition of multiple visit arms. In addition, there is a "seamless interface" with Microsoft Project.

With the new features, sponsors can better leverage IMPACT's investigator management functionality, says Kate Trainor, vice president of Perceptive Informatics' integration services group. "Sponsors can measure investigator performance worldwide across studies."

Flexibility of the tool has also improved to accommodate the growing variety of clinical trials, says Adibi. IMPACT "allows customers to add new fields and adopt functionalities of the system, or turn off functionalities they don't think apply."

IMPACT, acquired by Parexel about four years ago, has been commercially available since 1998, says Adibi. With more than 26,000 users in 85 countries, it is the world's most widely used CTMS technology. The reason is that it "looks holistically across an enterprise at all trials study sponsors work on." Clinical trials are, and always have been, its core business.

Several customers have already migrated to the new MySites module, which was released August 9, says Trainor. "There's a lot of excitement about the application among our international user groups." The module will likely be a "big area of growth" for Perceptive Informatics, in part because Parexel is one of the key "customers" implementing it. Parexel works with the top 10 biotechnology companies, the top 20 pharmaceutical companies, and has clients throughout the world in the pharmaceutical, biotechnology, and medical device industries.

Sponsor companies that use IMPACT will be looking for clinical research organizations that use the same system, including MySites, says Trainor. "It will enable them to get better data faster."

Business Is Booming at Nextrials
By Deborah Borfitz

Nextrials saw stellar growth in both revenue and sales during the first half of 2007. The chief reason is that many existing customers - composed almost entirely of small to mid-size biotech companies, medical device firms, and smaller clinical research organizations (CROs) -- are expanding their clinical programs and transitioning from small Phase II to larger, global trials.

So says CEO James Rogers, adding that Nextrials has also just released software that should give it an inroad with bigger CROs and, eventually, big pharmaceutical companies. He's referring to a new study design tool for Prism, Nextrials' electronic data capture (EDC) product, which allows users to easily devise their own database and edit checks. Smaller companies typically don't have the staff to be do-it-yourselfers.

As it is, Nextrials' revenues in the first half of 2007 mushroomed 60 percent over the same period last year. Sales saw a double-digit increase. Six new clients and 18 new studies were acquired. Rogers says that Nextrials is benefiting both from growing industry-wide adoption of EDC and improvements to its own business development efforts.

New clients include EKOS Corp., a Bothell, WA-based medical device company that has selected Prism for an upcoming patient registry study of ultrasound-assisted, fluid infusion catheters in treating peripheral arterial and deep vein thrombosis blood clots.

Among the repeat customers is ArQule Inc., a biotechnology company based in Woburn, MA, that specializes in oncology. Due to the increasing scope of its clinical trials, ArQule's per-study budget has literally tripled since Nextrials began working with the company in the last half of 2006, says Rogers. "ArQule recently received a large investment from Kyowa, a Japanese pharmaceutical company, to expand the clinical trial program for one of its promising biologics. We've done a lot of studies with [ArQule], and more studies are planned before the end of the year."

Toward the end of 2007, Nextrials expects to start seeing revenues from its newly built patient recruitment module for automatic patient recruitment identification and randomization, says Rogers (see At Nextrials, It's All About Standards, eCliniqua, June 4, 2007). The module allows hospitals' electronic health record (EHR) systems to troll for subjects matching study protocol criteria. "We're working to find a partner to launch the pilot. We're talking to an EHR company and a not-for-profit health system now."

The patient recruitment module allows users to modify inclusion and exclusion criteria to see the affect it will have on patient recruitment, says Rogers. Further upstream, it will be used to predict enrollment based on protocol criteria.

Efforts by others to bring EHR and EDC together have been stymied by technical complications as well as the sheer number of players involved, says Rogers. "The biggest beneficiary and the most likely group to finance the development is the pharmaceutical industry, but success requires the cooperation of multiple parties with different priorities. Everyone is waiting for a solution to be put in place, but very few are stepping forward to actually make it happen. There have only been a couple of pilots in the U.S. and one in Germany that I've heard of. At this point, the hype is way ahead of any real progress."

Almac Aims to Speed Study Set-Up with IXR Express
By Catherine Varmazis

Almac Clinical Technologies has introduced the IXR Express interactive voice and Web response system for faster start-up times in simple to moderately complex clinical trials.

The IXR Express is designed to be flexible. It has a built-in menu of options so it can be used with many clinical protocols without customization. "We did research on hundreds of protocols and defined their common denominators and included them in the IXR Express," says Valarie Higgins, vice president of clinical project services at Almac.

Easier and faster to set up than Almac's IXRS system, the IXR Express does not require special configuration or complex coding. It can handle most kinds of randomization as well as any subsequent assignment change, such as crossover in treatment or a change of kit type.

An advantage of the IXR Express is that it captures both voice and Web data so they do not need to be replicated, says Joe Cunningham, director of business development. In addition, users do not have to predefine ahead of time which option - voice or Web - they want to use.  And they can switch between the two modes on the fly.

Higgins says the Web option is especially popular for administrative modules such as activating or deactivating a site. While many large pharmas have been slower than smaller users to move to Web-based data capture, their rate of adoption has been picking up speed in the last six months, she says.

According to Higgins, customer set-up time for the IXR Express is 75 percent faster than with the IXRS. The IXR Express is available now. Cost varies depending on the number of modules and other variables.

Cambridge Healthtech Institute and the Ontario Genomics Institute present the second annual:

Innovations in Clinical Trials: Implementation of Biomarkers
October 15-16, 2007 | Renaissance Hotel | Toronto, Ontario, Canada

Coverage includes:
-Addressing the Validation Bottleneck
-Biomarker Development from Validation to Clinical Implementation
-Bioimaging for Monitoring Response to Therapy, Dose Selection, Assessing Molecular Activity and Receptor Occupancy

For more information please visit: www.healthtech.com/2007/ctd/index.asp

Immediately followed by:

Putting Theory into Practice: Adaptive Clinical Trial Designs
October 16-17, 2007 | Renaissance Hotel | Toronto, Ontario, Canada

Coverage includes:
-Why and where adaptive trial designs should be used
-Adaptive designs as a portfolio management tool
-The use of Bayesian analysis in early decision-making
-Case studies from trials which used flexible designs
           -designs used
           -operational planning and logistical issues associated with implementation
           -lessons learned
-The perspective from government agencies
-Solutions to address issues raised by regulatory groups

For more information please visit: www.healthtech.com/2007/adt/index.asp

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