clinical trial supply services
Transcription
clinical trial supply services
CLINICAL TRIAL SUPPLY SERVICES • • • • • • Commercial Product Sourcing & Blinding Packaging & Labelling QP & Analytical Support Services Global Distribution & Depot Network Supply Chain Management IXRS® (IVR/IWR) Technology GLOBAL CLINICAL TRIAL SOLUTIONS FOR YOUR PROTOCOL NEEDS Almac has over 25 years’ experience delivering a full range of innovative clinical trial supply and technology solutions to pharmaceutical and biotech companies worldwide. We are the most trusted and stable name in the clinical supply marketplace. North America USA Souderton, PA (HQ)* Durham, NC (Almac Facility) Canada Mexico Headquartered in Craigavon, Northern Ireland - with US operations based in Durham, North Carolina and Souderton, Pennsylvania, as well as our newly opened facility in Singapore Almac champions integrated clinical supply and technological excellence to make your clinical trials more effective and efficient. We pride ourselves on working with all types of company, from virtual and biotech, to multi-national pharmaceutical companies. Europe UK (HQ)* Austria Belarus Belgium Bulgaria Croatia Czech Rep. Denmark Finland France Germany Hungary Israel Italy Netherlands Norway Poland Romania Above all, we are differentiated by our exceptional client service powered by an experienced team of knowledge-based project management specialists. Continual investment in our staff, global facilities and the ongoing delivery of innovative services position us as the premium provider of clinical trial supply chain solutions worldwide. Russia Slovakia Spain Sweden Turkey Ukraine Our new facility in Singapore, as well as our support office in Japan, allow Almac to offer a full clinical trial service to our Asia Pacific customers, supported by a regional team of Almac experts. Asia China Hong Kong India Japan Philippines Singapore South Korea Taiwan Thailand Central America Guatemala Panama South America Argentina Brazil Chile Colombia Peru ● Global Headquarters* Africa South Africa ● Depot Australia ● Regional depot with ability to ship to countries outside of the depot country NOT JUST EXPERIENCE. FORESIGHT. WE TURN EXPERIENCE INTO FORESIGHT AND ANTICIPATE THE NEEDS, CHALLENGES, AND OPPORTUNITIES IN THE EVOLVING AND EVER-CHANGING INDUSTRY OF GLOBAL CLINICAL TRIALS. COMPARATOR SOURCING & BLINDING • Global sourcing of comparator products for clinical trials. • Over-encapsulation services - from single tablet to complex fills. • Many novel approaches to product blinding including inhaler device blinding. • Clinical trial manufacture – via Almac Pharma Services. PACKAGING & LABELLING • Huge global capacity and effective use of automation. • Range of blistering, bottling and carding/ walleting lines to suit study demands. • Flexibility to cope with small scale requirements through to mega-trials. IMPs for use in clinical studies. Our QPs are widely known and respected within the industry, providing invaluable consultancy services to our client base. GLOBAL DISTRIBUTION & DEPOT NETWORK • Experience in shipping thousands of kits to existing and new trial destinations. • Global capacity and growing depot network. • Specialists in cold-chain, controlled drug and controlled ambient shipping. • STEMS (Shipping Temperature Electronic Monitoring System) - automatic upload of USB temperature monitors on-site. • Range of qualified shipper and monitor solutions. • Direct to Patient services available in the US, Canada and EU (subject to criteria). • Returns, accountability and destruction services. • High output blistering and in-line walleting to cope with large program volumes. • Pack design and format advice for optimum processing and study fit. • Label printing, on-line label approval and automated label verification. ANALYTICAL SERVICES Delivering comprehensive analytical solutions to support your drug substance (API) and drug product development programmes. We can also provide analytical and microbiological testing solutions for clinical / commercial drug product supply. EU QUALIFIED PERSON SERVICES (QP) We have a comprehensive team of experienced QPs who are able to assist clients with the importation of materials into the EU - as well as the release of SUPPLY CHAIN MANAGEMENT Almac’s Supply Chain Management experts offer years of experience, flexibility to fit our clients’ needs and a dedicated focus on the patient. • Dedicated Supply Chain Management Team to plan, build and manage your clinical supply chain. • Integrated technology for the forecasting, planning and global oversight of clinical inventory. • IXRS® (IVR/IWR) solutions to manage randomisation and supply. • WebEZTM - a configurable web-based randomisation system, ideal for smaller trials. • Temperature Surveillance – end-to-end monitoring to eliminate excursions and manage risk across the entire supply chain. • Pharmacy Services. www.almacgroup.com ALMAC GROUP ACROSS THE GLOBE Global Headquarters, UK Durham, USA US Headquarters Asia Pacific Headquarters All our clients have unique needs. That’s why we develop unique solutions. This is the GET IN TOUCH UK Almac Group (Global Headquarters) 9 Charlestown Road Seagoe Industrial Estate Craigavon BT63 5PW United Kingdom US Almac Group (US Headquarters) 25 Fretz Road Souderton, PA 18964 United States of America ASIA PACIFIC Almac Pharmaceutical Services Pte. Ltd. (Asia Pacific Headquarters) 9 Changi South Street 3 #01-01 Singapore 486361 clinicalservices@almacgroup.com +44 28 3836 2436 clinicalservices@almacgroup.com +1 215 660 8500 clinicalservices@almacgroup.com +65 6309 0720 AM5103