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)
25 Fretz Road
Souderton, PA 18964
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.
Clinical labeling of biological products, operating within ultra-low temperatures can present unique challenges. Read this case study to find out how one biotechnology company built an effective strategy to label temperature sensitive clinical trial material.
When a drug is required for both commercial and extended clinical trial use, this may cause strain on supply and demand operations. Discover how Almac Clinical Services used a pooled inventory strategy and Just In Time labelling (JTL) approach to maximize drug supply and minimize wastage.
Expiry date updates are a common aspect of clinical supply chain management. Discover how Almac coordinated expiry update labelling of investigative drug at numerous depots around the world.
Find out how adopting a ‘one team’ approach and utilizing a LEAN methodology enabled a clinical services provider to deliver when it mattered most.
It is critical that you understand the changing product landscape, the benefits of blinding, common trial designs and blinding methods, to ensure that you are not faced with any obstacles throughout your clinical study.
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
In the world of clinical trials and GxP activities, without documented evidence of an event, you cannot confirm what really happened. Learn how one large pharmaceutical customer, at risk of non-compliance to GDP due to a downturn in temperature data, improved their monitor compliance upload rate.
Direction from a solution provider with expertise in forecasting, packaging, labeling and distribution along with services of an IRT provider solves drug shortage challenge.
This informative eBook discusses supply vs. demand led planning, physical and digital clinical supply landscape, technology and drug conservation, key variables affecting clinical supply and much more.
How blinding benefits both the patient and the investigator and drug encapsulation is an effective blinding method.
Over-encapsulation is a widely accepted blinding mechanism used throughout the clinical supplies industry, and while the process itself may appear relatively straightforward, packaging for clinical supplies is a complex process that is strictly controlled by Good Manufacturing Practices (GMP).
The advantages of biologics over their small molecule predecessors are not without their costs. This e-book addresses the challenges that need to be factored into the biologic drug development process and managing the biologic supply chain.