OR WAIT 15 SECS
24 February 2009, Yardley, PA.
Almac Clinical Technologies announced today that it has completed its first paperless client audit. As a part of Almac’s effort to move towards a paperless environment, this is a major milestone that offers clients opportunities to greatly enhance the rigor and quality of auditing vendors as well as reduce the time and costs associated with traditional paper audits.
The process of auditing a vendor can be very time-consuming for a sponsor. Typically, days are spent searching binders and file folders for documents and SOPs. In a paperless audit, clients are presented with an electronic file of all system documentation up front for them to review. Clients spend their time more efficiently by having the ability to search key words, documents and SOPs electronically. They can drill down into specific areas of the system development lifecycle (SDLC) that most interest them.
Dr. James Huang, Director of Quality Assurance and Validation, explains “Our ability to perform our paperless audits will bring many benefits to clients. The efficiencies created for clients such as time-savings and easier searching mechanisms make for a more quality-driven audit process. In the near future, we’re hoping to enable clients to audit us remotely via online, saving them travel expenses.”
Dr. Joseph Bedford, Director of Marketing, comments on the firm’s commitment to protection of the environment. “Almac is committed to reducing paper across its businesses, and our paperless audit is another step in that direction. Our employees are passionate about environmental conservation and a pollution-free community, and have demonstrated remarkable leadership and discipline in our paperless efforts.”
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; iTrial EDC for electronic case report form data collection; electronic patient reported outcome 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 50 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/EDC), to commercial-scale manufacture. Almac provides services to over 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 $100m North American Headquarters started in July 08 and is expected to be completed 2010.