Clinical Services and Technologies
Meanwhile, Almac Clinical Services, which was established 20 years ago, is focused exclusively on clinical trial supplies and has now completed over 6,000 clinical protocols. “Innovation is one of our key drivers,” says Robert Dunlop, Ph.D., president and managing director, Almac Clinical Services.
This division has averaged over 20% growth each year for the last 10 years, working with all organization types. Besides the Craigavon facility, Almac Clinical Services also has a presence in the U.S. Services offered include: blinding, packaging, labeling, label generation, QP release, global distribution, depot network, analytical services, and project management. The company has pioneered a number of systems to meet client demand, including a web-based randomization and patient-management system, an automated vision label-verification system and inhaler blinding processing technology, according to Dr. Dunlop.
A suite of web services was launched in April that allows clients to approve their clinical labels online with an electronic signature. Another project involves the implementation of a global IT system that will allow for global management of all clinical trial activity.
Almac Clinical Technologies offers a number of technology and service solutions to increase the quality and efficiency of the clinical trial process, says Joe Cunningham, business development director. The core products are: interactive voice response systems (IVRS), IXRS™ (web- and phone-enabled IVRS), iDiary (ePRO—electronic patient reported outcomes), and iTrial EDC™ (electronic data capture). For sponsors with challenging timelines, less complex studies, and tighter budgets, Almac Clinical Technologies offers its Express line of services that include IVRS/IXRS Express and EDC Express.
IXRS is a cost-efficient technology for managing complex, global clinical trials covering study, patient, and drug management, adds Cunningham. The iDiary/ePRO solution is a cost-effective way to collect critical study data that helps clients retain their patients by making it easier to report health outcomes during clinical trials. The product fits well with recent FDA guidelines on electronic patient diaries. “Our system eliminates so-called parking-lot syndrome, where patients are forced to catch up on their entries at the last minute,” says Cunningham.
iTrial EDC is an integrated web-based data-capture system that allows clients to improve data quality, study timelines, and speed to market, Cunningham notes. “It gives us an advantage when integrated with our other tools, he adds. “For instance, there is no need for dual data entry.” Express is a tool involving prebuilt and tested solutions, it is of use to companies wanting to carry out less complex clinical trials. On Almac Clinical Technologies’ horizon is an expansion of the Express Suite and its integration with IXR, EDC, and ePRO.