Almac’s North Carolina Facility Continues Growth in Academically based Clinical Trials
May 5, 2010
Almac Clinical Services has seen continued growth from clients operating in the not- for-profit sector on academically based clinical trials. The site in Durham which recently doubled capacity and passed an FDA inspection, also operates as a licensed pharmacy. The unit was originally part of the Duke Clinical Research Institute from 1990-2000 when all of the studies handled were physician-led and academically based.
With its academic origins and many of their key Project Leaders fully qualified pharmacists it is not surprising that the site is seeing increased partnerships with academically led Clinical Trials. Staff experienced with this specific client type are aware of the deeper level of involvement required from the outset and have an understanding of the full clinical trial process –disease state knowledge, how patients move through the hospital and pharmacy best practice when working directly with investigators. Project Leaders are also involved with writing the CTM section of the clinical protocol through to reconciling drug returned from the clinical sites at close out.
Donna Christopher, VP of Operations at Almac Clinical Services, Durham Facility commented ‘As our business continues to evolve under the Almac brand we have stayed close to our roots in academically based clinical trials – an area where our expertise lies. Alongside our core contract services, we also advise many of our clients on how to conduct their trials. From the outset we provide information on clinical input, study materials required, efficient drug kits design as well as full supply chain management in addition to providing training and monitoring to sites. We work together with our Academic clients to ensure their clinical trials are run to maximum efficiency enabling them to focus solely on their trial results. . In recent months we have doubled our capacity to enable us to meet the increased demands for our services.”
Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.
The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters in PA started in July 08 and will be completed in 2010.