Almac, PHT Form Clinical Trial Quality Alliance

Almac Clinical Technologies and PHT Corp. have entered an alliance to improve clinical trial productivity through various education initiatives and data integration efforts aimed at reducing trial site problems and improving data collection and reporting.

PHT and Almac will provide consultation with clinical trial sponsors on the appropriate technology for studies involving electronic patient-reported outcomes (ePRO). According to the companies, sponsors currently face challenges with choosing a system to capture ePRO data in trials. PHT and Almac will also conduct several workshops and panel sessions on this topic at industry events in 2009-10.

The first joint data initiative involves integration of Almac’s patient screening and randomization data with PHT’s handheld devices for ePRO studies. Sponsors who choose to work with the alliance will have access to real-time data feeds from Almac’s IVR/IWR technology directly into PHT’s handheld ePRO product suite, the LogPad and SitePad Systems. According to the companies, this integration eliminates the need for sites to manually enter the same information twice. Future efforts will include seamless integration between Almac’s study data with that collected by PHT and EDC vendors. Both Almac and PHT’s offerings integrate with other systems using CDISC standards.

Philip Lee, chief executive officer of PHT, remarked, “Our customers are constantly looking for ways to integrate multiple streams of eClinical data and reduce the data entry burden on sites. Our partnership with Almac offers added value for both sponsors and sites with one less data source to reconcile and the removal of a manual data entry step. Together, PHT and Almac are helping sponsors and sites remove time-consuming data cleaning tasks to focus on what they care about most, the health and safety of patients and conducting rigorous scientific research.”