ABOUT ALMAC GROUP
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)
Seven Reasons To Consider A Just In Time Manufacturing Approach For Your Clinical Trial Supplies
Evaluating the potential that modern drug production methods offer, in terms of increased supply chain optimization and agility, is essential for sponsors. Read Almac’s article to find out how Just in Time Manufacturing can help deliver a flexible, continuous, and cost-effective clinical supply chain operation.
Almac Delivers Same Day Compassionate Use Shipment For COVID-19 Patients
The COVID-19 pandemic is placing sharp focus on a sponsor’s ability to meet pressing clinical supply chain timelines. Read Almac’s latest case study to learn how in one urgent situation, patients fighting COVID-19 were given fast access to potentially life-saving treatment.
Unified IRT And Clinical Supply Aligns Processes To Meet Timeline
Unified IRT and clinical supply aligns processes to meet aggressive drug delivery timeline. Unifying the physical and digital aspects of clinical supply chain management with a single vendor has been proven to significantly reduce errors, demand less time and resource from sponsors, deliver process automation to drive efficiency, and offer a holistic view of data that facilitates smart decision making and continuous improvement. Download Almac’s case study to find out how one sponsor was able to meet ambitious study milestones, thanks to the Almac ONE service.
Creating Patient-Centric Supply Chains With Just In Time Manufacturing
As sponsors adapt to the rapidly developing COVID-19 landscape, there is a need to ensure patients remain at the heart of supply chain operations. Learn how Just in Time Manufacturing is one way sponsors can embrace patient centricity, while effectively redesigning supply chains to respond to the additional challenges presented by the ongoing global pandemic.
Increasing Volume Of Essential Clinical Supplies To Patients In Their Homes As Part Of Ongoing Response To COVID-19
COVID-19 poses an unprecedented threat to the continuity of supply of vital medications to patients enrolled in clinical trials around the world. Providing a range of distribution options tailored to sponsors safeguards patients and maintains vital study timelines.
Adopting Label Change Best Practice To Promote Clarity And Compliance
Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.
Almac’s Webinar Series: Clinical Trial Supply And Technology
Download Almac’s on demand webinar series that discusses the multitude of efficiencies gained when harmonizing the clinical supply chain and tips for simplified supply planning. Follow the life cycle of the physical clinical supply chain from bulk manufacture to destruction, demonstrating the effective use of integrated digital systems for site, drug and patient management.
LEAN Packaging Process Supports Pfizer’s Urgent Mission To Dose Child With Life Enhancing Gene Therapy
Download this case study to discover how Almac’s LEAN packaging process supported Pfizer’s urgent mission to dose a child diagnosed with Duchenne Muscular Dystrophy (DMD), with a life enhancing gene therapy.
Comparator Sourcing: The Challenge Of Compliantly And Cost-Effectively Navigating Global Supply Chains
The challenge of compliantly and cost-effectively navigating global supply chains, often involving high-value, temperature-sensitive products, has never been greater. This eBook explores the growing significance of comparator product use, typical sourcing models and the common pitfalls sponsors should look to avoid.
Almac’s W5 STEM Program Scoops ‘Innovation In Sponsorship’ Award
Almac Group is delighted to announce Almac has won the “Innovation in Sponsorship” award during this year’s Irish Sponsorship Awards ceremony in Dublin.
Almac Scientists To Develop Novel Manufacturing Process For Essential Medicine
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.
Maximizing Efficiencies With Effective Biologics Supply Chain Management
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.
Agility And Expertise Combine To Overcome Late Stage Design Issues In Comparator Study
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.
Tailored Ultra-Low Temperature Labelling Environment Enables Trial Success
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.
Expert Project Management And An Effective Comparator Sourcing Strategy Streamlines Sponsor’s Complex Global Trial
Some clinical trials face numerous and critical complexities which increase pressure and risk for the success of the trial. By partnering with Almac, a drug 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 Solution
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.
Harnessing Effective Cold Chain Capability To Absorb The Impact Of Mid-Study Protocol Changes
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.
The Journey From Production Line To Patient: Exploring The End-To-End Requirements Of A Successful Cold Chain Operation
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.
Customized Labelling Solution Delivers Seamless 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.
Putting Patients First By Introducing Supply Chain Visibility And Efficiency To Investigator Initiated Trials
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.