Member Contact: Helen Leiton
Position: Regional Support Manager
Industry: Biotech & Pharmaceuticals
Almac Clinical Services
As trials become truly global, sponsors require partners that can provide the physical means of packaging and distributing their supplies, as well as providing the data to facilitate planning and enable decision-making. Almac Clinical Services, part of the Almac Group – a leading contract development and manufacturing organisation has over 30 years’ experience delivering a full range of innovative clinical trial supply and technology solutions to pharmaceutical and biotech companies worldwide. They are the most trusted and stable name in the clinical supply marketplace.
Headquartered in Craigavon, Northern Ireland - with US operations based in Durham, North Carolina and Souderton, Pennsylvania, in addition to a facility in Singapore and Japan – Clinical Services champions integrated clinical supply and technological excellence to make their customers’ clinical trials more effective and efficient. They work with all types of companies, from virtual and biotech, to multi-national pharmaceutical companies. Almac provide the physical resources and supportive technologies that ensure your clinical supply chain continually delivers across the globe.
Products and Services
• Global Clinical Supply Chain Management – Almac has experienced consultants who can guide sponsors to make smart clinical supply chain decisions. Leveraging their experience with thousands of clinical trials, global physical infrastructure, and innovative technology solutions, Almac’s experts can assume ownership and decision making for the clinical supply chain from end to end, or complement the customer’s existing supply chain resources, making it a nice fit for just about any company.
• Global Packaging & Distribution Facilities – Almac offer flexible packaging and distribution facilities across the Globe. Almac offer an extensive range of primary and secondary clinical supply packaging solutions and deliver the most compliant and effective packaging design for your study. With every element of packaging follows distribution, Almac manage the shipping of Investigational Products (IP) through their global depot network, and expertise in biological, controlled and ambient product delivery.
• Next Generation Temperature Management – Almac understand your temperature control challenges and so their experts have developed an end to end regulatory compliant solution that gives full visibility of your temperature data from any stakeholder within your supply chain. Almac’s TempEZ™ platform offers clients a single database to store temperature data from product manufacture through to patient administration, as well as providing a platform to ensure compliance to cGXP and GDP regulations. TempEZ™ is part of Almac’s Next Generation Temperature Management portfolio and is supported by an industry leading temperature services team, to support the monitoring and compliance of your temperature controlled shipments. The portfolio also includes the company’s phase change shipper, the Almac Pod™, as well as a range of temperature monitors for easy integration with TempEZ™.
• Commercial Drug Procurement – Almac understands that sponsors require an end-to-end service that can provide comparators on a global scale, so with vast experience in this area, Almac are able to source comparator products across all clinical markets, assuring supply for thousands of clinical studies.
• Almac ONE™ – Only ONE Unified Clinical Trial Supply Solution has redefined the supply chain experience to create a responsive end-to-end process that bridges the physical and digital connect. The result – enhanced visibility and accuracy throughout the lifecycle of a sponsor’s study. Combining cross functional expertise and leading technology applications: IRT (IXRS®) + ERP (COSMOS) + Temperature Management (TempEZ™) + Forecasting (SupplyWise™), Almac ONE™ has the combined expertise to securely and accurately collect and share pre-validated patient data helping to develop the solutions needed to solve the challenges sponsors face. This enables sponsors to streamline their studies providing a unified view of data achieving Almac ONE’s goal of creating optimised, efficient and patient-focused Clinical Supply operations.