Almac’s Clinical Services Business Unit is here to help the biopharmaceutical industry bring new therapies to those in need by empowering trial sponsors to proactively manage sites, patients, and clinical supplies through our industry-leading technology and expert consultancy.
The solutions we offer facilitate more than simplifying patient and trial material management – they engineer quality into the clinical trial process. Our technology provides sponsors and CROs with the visibility and control needed to make data-driven decisions by leveraging advanced supply management functionality coupled with real-time site and patient data in a closed-loop environment.
Almac Clinical Services is part of the Almac Group. The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 3,900 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo)
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Almac Group, the global contract pharmaceutical development and manufacturing organisation, has been awarded $200,000 by the Bill & Melinda Gates Foundation (BMGF) to develop novel biosynthetic routes with the aim of substantially lowering the cost of selected steroidal Active Pharmaceutical Ingredients (APIs) and enable their use in developing world aid programs.
Operating biologics-based clinical trials presents several unique challenges and the cost involved in developing these pioneering drugs leaves little margin for error. Download this case study to learn how Almac’s supply chain experts helped one sponsor deliver operational efficiencies and cost-effective medication management for a global Phase III trial.
Encountering unforeseen problems when sourcing a comparator for an investigational product can severely impact the success of a clinical trial. Download this case study to learn how Almac Clinical Services helped one sponsor overcome late stage design issues through successful sourcing and procurement of a suitable alternative comparator.
Clinical labelling is a function that has the potential to make or break a study, depending upon design and execution. Incredibly specific and complex handling requirements associated with new medicines and biologics amplifies the challenge of compliantly packaging and labelling clinical supply. In our latest case study, we look at the complexities involved in labelling and kit assembly of an IP with very rigid, ultra-low storage and stability conditions.
Some clinical trials face numerous and critical complexities which increase pressure and risk for the success of the trial. This case study, highlights the complexities faced by one sponsor that were compounded by rigid timeframes, comparator sourcing availability, sensitized drug product and intricate kit design. By partnering with Almac, the sponsor was able to harness Almac’s expertise in project management and comparator sourcing to deliver multiple shipments to sites and depots on time and within specified conditions.
Almac Adapt™ Just in Time Manufacturing enables full late stage customization of your clinical supplies by postponing packaging and labelling until the site or patient need arises. This solution ensures finished patient kits are packaged, labeled and shipped only when needed, resulting in reduced timelines, wastage and product shortages to ensure budgetary and protocol efficiencies.
The most successful clinical trials have one thing in common: sponsors never stop looking for ways to improve processes that support the core objective of delivering safe, compliant investigational product to patients, when and where they need it. Read Almac’s latest case study to learn how they helped one sponsor effectively manage a drug formulation change mid-trial without study interruptions or patient impact.
Read Almac’s latest article that explores the cold chain journey, from production line to patient, to learn how you can overcome challenges within your temperature controlled supply chain. By exploring end-to-end requirements at the earliest opportunity and adjusting manufacturing strategies accordingly, safe, agile, and optimized cold chain operations can be created for your clinical trial.
Clinical labelling is a function that has the potential to make or break a study, depending upon design and execution. A function that was once seemingly on the periphery of clinical trial management has now taken on a new level of significance with increasingly complex labelling requirements. This case study highlights the complexities involved in label design and execution and how Almac worked with one sponsor to identify and rectify a flawed design to ensure a seamless trial, an improved patient experience and enhanced overall trial performance.
Investigator Initiated Trials (IITs) play an important role in helping sponsor companies better understand their drugs. However, managing these studies presents unique and complex clinical supply chain challenges. Download the case study to find out how Almac Clinical Services helped one biotechnology company effectively manage drug supply for multiple IIT programs.
A competent Importer of Record is a prerequisite to any successful global clinical trial. The role is vast and the remit wide, covering everything from ensuring imported goods comply with local law and regulations, payment of import duties, tariffs and fees; to risk mitigation and maximizing opportunities to ensure the right drug, gets to the right patient at the right time.
Investigator Initiated Studies (IIS) offer pharmaceutical sponsor companies the benefit of increasing product knowledge and expanding the medical use of their drug. However, managing these studies presents unique clinical supply chain challenges and can become a very complex process. In this webinar, Almac’s clinical supply experts address these challenges and provide insight into how to best manage investigator initiated clinical studies.
Almac Clinical Technologies, a member of the Almac Group, has recently published a report which finds that the use of an automated chain-of-custody system can save a minimum of $1,300,000 per clinical trial in operating costs.
It is difficult to quantify the soft costs of managing a clinical trial. One factor guilty of contributing to spiraling soft costs is time. Download Almac’s case study that demonstrates how Almac’s One Clinical Trial Supply Solution helped a pharmaceutical company streamline its clinical trial operations, resulting in time and cost savings.
Almac Group announces Almac One™ - providing the first unified Clinical Trial Supply solution. This solution redefines the Clinical Supply Chain experience, creating a responsive end-to-end process that enhances visibility and accuracy throughout the lifecycle of a clinical study.
Discover how Almac helped one pharmaceutical company streamline processes and remove risk from their multiple clinical trial applications while maintaining data integrity with One Unified Clinical Trial Supply Solution.
Watch Almac’s on-demand webinar to gain an understanding of data integrity regulations and key considerations when utilizing a computerized system to manage temperature data during clinical trials. This webinar will demonstrate how a secure, validated system is key in ensuring effective collection and management of accurate temperature data from the entire clinical supply chain.
When one pharmaceutical sponsor was faced with unreliable demand forecasts, Almac Clinical Services helped implement a LEAN supply chain approach to ensure clinical sites received the right drug quantities needed to support all patients in a global Phase III trial.
Successful clinical trials require accurate demand forecasting, efficient distribution channels and a secure supply chain strategy. Find out how Almac Clinical Services helped one sponsor implement an optimized clinical supply strategy that resulted in an uninterrupted clinical trial and reduced costs.
The distribution of Investigational Medicinal Products (IMPs) has become an increasingly complex part of the clinical supply chain. Download our white paper to understand why an effective distribution strategy is essential to a clinical trial’s success.