Almac and PHT Announce Formal Alliance to Improve Clinical Trial Data Quality
April 23, 2009
Almac Clinical Technologies and PHT Corporation announced a formal alliance today to improve clinical trial productivity through a variety of education initiatives and data integration efforts that will reduce clinical trial site burdens while improving study data collection and reporting.
As part of their alliance activities, PHT and Almac have agreed to provide consultation with clinical trial sponsors on the difficult question of choosing the appropriate technology for studies involving electronic patient-reported outcomes (ePRO). Currently, sponsors face challenges relating to choice of using either a handheld device or an interactive voice or Web response system to capture ePRO data in their trials. To help clients better understand this issue, PHT and Almac will offer joint consultation with clients upon request and 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 both Almac and PHT will be afforded the opportunity to have real-time data feeds from Almac’s industry-leading integrated IVR/IWR technology directly into PHT’s market-leading handheld ePRO product suite, The LogPad® and SitePad™ Systems. Almac will send PHT real-time automated feeds whenever a patient is screened and randomized, improving data quality for sponsors and increasing clinical trial sites’ productivity. The integration will remove the need for sites to manually enter in the same information provided by the Almac IVR system into the LogPad thereby reducing the opportunity for costly and time-consuming data entry errors. Future efforts will involve deeper data integration, including seamless integration between Almac’s study data with that collected by PHT and EDC vendors. Both Almac and PHT’s advanced technology offerings consistently integrate with other systems using CDISC standards.
Philip Lee, CEO of PHT comments about the benefits that the alliance will provide to clients.
“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.”
Almac Clinical Technologies’ President Jim Murphy believes that deeper integration of data between best-of-breed technology vendors offers tremendous benefits for sponsors.
“Obtaining the highest quality data from vendors and sites is the primary need of pharmaceutical study sponsors. This alliance satisfies that need by integrating data from the highest quality clinical technology companies. The Almac/PHT alliance offers sponsors an opportunity to resist compromising data quality and trading off high quality technology or customer service to work with one vendor who offers all technologies for data collection, but is not best-of-breed in all or any of them.”
PHT and Almac plan to launch their integrated offering by mid-2009. Further details about the alliance and joint initiatives are available by contacting either PHT or Almac Clinical Technologies.
Both Almac and PHT will be exhibiting at next week’s Partnerships with CRO’s Conference, come visit them for more information at Booth’s 317 and 520.
T: (001) 267-685-4284
PHT is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in more than 390 clinical trials by 100 biopharmaceutical clients. The proven LogPad® System and revolutionary SitePad™ Tablet deliver the voice of the patient, in 80 languages, from homes and sites in 60 countries around the world. By capturing high-quality and time-stamped assessments with minimal respondent burden, trial sponsors are able to run smaller and more conclusive clinical research programs resulting in significant R&D cost savings. Real-time study management through PHT StudyWorks™ features eClinical data integration, standard and custom data summaries for compliance and enrollment, SafetyPRO™ email alerts, and the industry’s premier study archive. Patient experiences captured firsthand by PHT’s ePRO Product Suite have been used successfully in at least 11 NDA submissions and seven approvals to date. For more information, review interactive product demonstrations at the award-winning www.phtcorp.com
About Almac Clinical Technologies
Almac Clinical Technologies is a division of the Almac Group that specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Our solutions include Interactive Voice and Web Response Systems (IXRS™) for patient randomization, tracking and clinical supply management; EDC for electronic case report form data collection; electronic patient reported outcomes data collection; and Web drug reconciliation. Almac’s technologies have been deployed in over 1300 clinical trials, incorporating over 1.5 million patients in over 80 countries and more than 60 languages.
About Almac Group
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.
The company employs over 2,400 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.