Almac Clinical Technologies goes with a PRO

Ireland-based company names as partner for electronic distribution of patient-reported outcomes

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YARDLEY, Pa.—Citing three principal reasons for partneringwith, Almac Clinical Technologies announced in December "a uniquepartnership for electronic distribution of FACIT's patient-reported-outcomes(PRO) and quality-of-life (QOL) assessments.

According to Dr. Joe Bedford, Almac's director of marketing, has several scales that are frequently used in oncology clinicalstudies, an area where Almac and its sister divisions, Clinical Services andDiagnostics, also have a great deal of experience.

"Another main reason," Bedford states, "is that they conductlanguage translations to validate studies worldwife, which we have beenoutsourcing."

Finally, FACIT proved to be very flexible about validatingtheir scales using Almac's electronic product. The partnership agreement empowersAlmac to use and validate leading FACT and FACIT assessments through any andall electronic modalities including phone, Web and handheld devices.

FACIT questionnaires, including the Functional Assessment ofCancer Therapy-General (FACT-G), have been used in hundreds of clinical trialsfor oncology and other therapy areas and indications. The FACT-G (now inVersion 4) is a compilation of general questions divided into four primary QOLdomains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being,and Functional Well-Being. It is used widely with any form of cancer, and hasalso been applied and validated in other chronic illness conditions, such asHIV/AIDS and multiple sclerosis.

Seth Brennan, IXR product manager at Almac, notes that thecompany's patented technology is a single database with an "input agnosticfront-end. The system can handle Web, phone, and texting as well as customhandheld devices. This allows us to collect better data because no one inputsolution can fit all the scenarios," he says. 

As an example, Brennan mentions the case where a patient maybe comparing a rash to a series of pictures in order to grade severity as asituation where not all input devices are equal. He also notes that mobilephones and PDAs are dominant in Asia, while the Web is the input devicepreferred by patients in the U.S. and Europe.

The Almac product consists of a number of core modules,Bedford relates, with major, prevalidated features and functionality that helpspeed building and deploying individual studies. Drug supply management isanother important component of the system. Study sponsors can look at druginventory and, at a glance, trigger shipments as needed. The software is alsoused during the patient screening process for inclusion or exclusion. Onceenrolled, patients are blinded or unblinded, randomized and assigned drugs orplacebo, all by the IXR. All input sources are used for patient-reportedoutcomes (PRO) and quality of life reporting.

"Making the system tech-friendly moves studies along andhelps keep patients in," says Bedford. "It also results in automatic timestamping of every event, unlike diaries which are not always accurate. The endresult is a lot less follow-up is necessary to analyze and validate the data." 

Founded as ICTI in 1995 (the name was changed to Almac twoyears ago), the company has conducted about 1,500 clinical trials in more than80 countries, a track record that Dr. Bedford says puts Almac in the "numberone or two spot." In 2010, the company will move to its new headquartersbuilding on a 40-acre site in Harleysville, Pa., in Lower Salford County, whichit will share with Almac Clinical Services.

Clinical Services packages, labels and blinds drugs used intrials and ships them to depots, then to trial sites. 

"We'll share access to information to more effectivelyintegrate our services," Bedford says. "It will be a real boon, because BigPharma is looking for bundled services, and the bigger the bundle, the better."

Almac Diagnostics expands bioinformatics facility

CRAIGAVON, Ireland—Almac also announced in December that ithas expanded its bioinformatics department, including the opening of a dedicatedbioinformatics facility in Manchester, England. Almac's bioinformatics groupspecializes in gene selection, disease characterization and classification.

According to Almac, the company has shown significant growthin the last year, with employee numbers growing by 15 percent in the U.K. and10 percent in the United States.

"With our commitment to the delivery of personalizedmedicine, we have extended our bioinformatics group to increase our expertisein companion diagnostic development, pharmacodynamic biomarkers, diseaseclassification and prognostic markers," says Prof. Paul Harkin, president andmanaging director of Almac Diagnostics. "Our extended expert bioinformaticscapability assists our dedication to the advancement of patient care throughtranslational genomic solutions."

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