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Almac Clinical Technologies goes with a PRO
YARDLEY, Pa.—Citing three principal reasons for partnering with FACIT.org, Almac Clinical Technologies announced in December "a unique partnership 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, FACIT.org has several scales that are frequently used in oncology clinical studies, an area where Almac and its sister divisions, Clinical Services and Diagnostics, also have a great deal of experience.
"Another main reason," Bedford states, "is that they conduct language translations to validate studies worldwife, which we have been outsourcing."
Finally, FACIT proved to be very flexible about validating their scales using Almac's electronic product. The partnership agreement empowers Almac to use and validate leading FACT and FACIT assessments through any and all electronic modalities including phone, Web and handheld devices.
FACIT questionnaires, including the Functional Assessment of Cancer Therapy-General (FACT-G), have been used in hundreds of clinical trials for oncology and other therapy areas and indications. The FACT-G (now in Version 4) is a compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is used widely with any form of cancer, and has also been applied and validated in other chronic illness conditions, such as HIV/AIDS and multiple sclerosis.
Seth Brennan, IXR product manager at Almac, notes that the company's patented technology is a single database with an "input agnostic front-end. The system can handle Web, phone, and texting as well as custom handheld devices. This allows us to collect better data because no one input solution can fit all the scenarios," he says.
As an example, Brennan mentions the case where a patient may be comparing a rash to a series of pictures in order to grade severity as a situation where not all input devices are equal. He also notes that mobile phones and PDAs are dominant in Asia, while the Web is the input device preferred 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 help speed building and deploying individual studies. Drug supply management is another important component of the system. Study sponsors can look at drug inventory and, at a glance, trigger shipments as needed. The software is also used during the patient screening process for inclusion or exclusion. Once enrolled, patients are blinded or unblinded, randomized and assigned drugs or placebo, all by the IXR. All input sources are used for patient-reported outcomes (PRO) and quality of life reporting.
"Making the system tech-friendly moves studies along and helps keep patients in," says Bedford. "It also results in automatic time stamping of every event, unlike diaries which are not always accurate. The end result 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 two years ago), the company has conducted about 1,500 clinical trials in more than 80 countries, a track record that Dr. Bedford says puts Almac in the "number one or two spot." In 2010, the company will move to its new headquarters building on a 40-acre site in Harleysville, Pa., in Lower Salford County, which it will share with Almac Clinical Services.
Clinical Services packages, labels and blinds drugs used in trials and ships them to depots, then to trial sites.
"We'll share access to information to more effectively integrate our services," Bedford says. "It will be a real boon, because Big Pharma 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 it has expanded its bioinformatics department, including the opening of a dedicated bioinformatics facility in Manchester, England. Almac's bioinformatics group specializes in gene selection, disease characterization and classification.
According to Almac, the company has shown significant growth in the last year, with employee numbers growing by 15 percent in the U.K. and 10 percent in the United States.
"With our commitment to the delivery of personalized medicine, we have extended our bioinformatics group to increase our expertise in companion diagnostic development, pharmacodynamic biomarkers, disease classification and prognostic markers," says Prof. Paul Harkin, president and managing director of Almac Diagnostics. "Our extended expert bioinformatics capability assists our dedication to the advancement of patient care through translational genomic solutions."