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)

FEATURED SERVICES

Almac Adapt™ Just In Time Manufacturing Solution - Because Time Is Precious

Almac Adapt is a Just In Time Manufacturing solution which puts patients first and provides sponsors with a unique, adaptive supply strategy to ultimately meet the expanding challenges of clinical trials.

Next Generation Temperature Management Solutions Next Generation Temperature Management Solutions

Almac designed the innovative temperature management software TempEZ to ensure complete visibility of your drug’s temperature journey throughout the supply chain. TempEZ offers clients a single database to store temperature data from product manufacture to patient administration.

Almac ONE: One Unified Clinical Trial Supply Solution

Almac’s One Unified Clinical Trial Supply Solution has one objective to guarantee the study drug is with the patient at the right time while ensuring the complete chain of custody and minimising wastage of drug from production to destruction.

Clinical Supply Chain Management Clinical Supply Chain Management

With the increased globalization of clinical trials and development of biologics, the clinical supply chain can feel like uncharted territory.What if you were able to tap into the experience of thousands of clinical trials when designing your drug supply strategy? What if you could see different ideas in practice and understand what works and what doesn’t?

Global Clinical Trial Solutions For Your Clinical Trial Global Clinical Trial Solutions For Your Clinical Trial

Almac has over 30 years’ experience delivering a full range of innovative clinical trial supply and technology solutions to pharmaceutical and biotech companies worldwide. Our experts are able to understand client needs and deliver innovative solutions, in an evolving and ever-changing industry.

Next Generation Temperature Management Next Generation Temperature Management

With an increasing number of biologics and biosimilars in development, management of the complete supply chain for pharmaceutical products requires a complete solution.

Commercial Drug Procurement Commercial Drug Procurement

Sponsors require an end-to-end service that can provide comparators on a global scale. We understand that this requires a full supply chain solution to manage a clinical trial.

Supply Chain Management for Global Clinical Trials Supply Chain Management for Global Clinical Trials

Expertise in the blinding, packaging and global distribution of investigational products.

Blinding of Clinical Trial Supplies Blinding of Clinical Trial Supplies

Offered as part of our complete supply chain solution, masking or blinding of clinical trial supplies removes investigator and patient bias and limits a potential placebo effect.

Clinical Packaging (Primary) Clinical Packaging (Primary)

Flexible, global and automated clinical packaging solutions.

Clinical Packaging (Secondary) Clinical Packaging (Secondary)

Experts in packaging patient kits and labelling.

Clinical Storage & Distribution Clinical Storage & Distribution

The knowledge we’ve gained from handling millions of international clinical supply shipments has helped us to develop an expertly managed service.

CONTACT INFORMATION

Almac Group

25 Fretz Road

Souderton, PA 18964

UNITED STATES

Phone: 215-660-8500

FEATURED ARTICLES

  • Tailored Ultra-Low Temperature Labelling Environment Enables Trial Success
    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
    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. 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 Solution
    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
    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
    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
    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
    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.

  • Unpicking The Complexity Of Importer Of Record Processes In Globalized Clinical Supply Chains
    Unpicking The Complexity Of Importer Of Record Processes In Globalized Clinical Supply Chains

    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.

  • Overcoming Clinical Supply Chain Challenges In Investigator Initiated Studies
    Overcoming Clinical Supply Chain Challenges In Investigator Initiated Studies

    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 Group Publishes Comparison Report On Automated vs Paper Based Accountability & Reconciliation

    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.

  • Consolidating IRT And Clinical Supply Management To Save Time And Costs
    Consolidating IRT And Clinical Supply Management To Save Time And 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 ™ – A Unified Clinical Trial Supply Solution

    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.

  • Closed Loop Technology And Integrated Expertise Mitigates Risk
    Closed Loop Technology And Integrated Expertise Mitigates Risk

    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.

  • Protecting The Integrity Of Your Temperature Data In A Digital World
    Protecting The Integrity Of Your Temperature Data In A Digital World

    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.  

  • Using LEAN Supply Chain Best Practice To Reduce The Risk Of Inaccurate Forecasting
    Using LEAN Supply Chain Best Practice To Reduce The Risk Of Inaccurate Forecasting

    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.

  • A New Resupply Strategy Turns An Emergency Into An Opportunity
    A New Resupply Strategy Turns An Emergency Into An Opportunity

    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 Perfect Remedy For Clinical Trial Distribution
    The Perfect Remedy For Clinical Trial Distribution

    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.

  • Formulating The Blueprint For Effective Clinical Labelling In Ultra-Low Temperature Conditions
    Formulating The Blueprint For Effective Clinical Labelling In Ultra-Low Temperature Conditions

    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.

  • Pooled Inventory And Just In Time Labelling (JTL) Meets Demand For Multiple Channels
    Pooled Inventory And Just In Time Labelling (JTL) Meets Demand For Multiple Channels

    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.

  • Maintaining Uninterrupted Drug Supply In The Midst Of Product Relabeling
    Maintaining Uninterrupted Drug Supply In The Midst Of Product Relabeling

    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.