ACM Global Laborataries
Meeting Diverse Testing Needs Worldwide

Unforeseen issues often punctuate the course of a clinical trial program. At a time when the global COVID-19 pandemic has slowed clinical trials, these research initiatives remain riven with pain points, with pressure mounting to execute early and mid-phase clinical trials, deliver high-quality and timely results. Set against these unprecedented challenges, clinical trials demand agile, forward-thinking scientific and industry expertise to glean actionable clinical insights leading to successful therapies and treatments. In doing so, they must combine the highest level of guidance with a personal approach to fast-track processes and achieve better and actionable results quickly and efficiently.

This is where ACM Global Laboratories is in a class by itself.

As a recognized leader in global clinical trial testing and central laboratory services, ACM Global Laboratories is nimble and ready to tackle any clinical trial and associated challenges—regardless of the trial size or complexity—while maintaining the ability to expedite and fast track various studies. The company’s strength emanates from its wholly-owned facilities and network of partner labs that allow supporting clinical trials in more than 7,000 sites across 65 countries worldwide, including the U.S., UK, India, and Singapore. Committed to delivering high-quality laboratory testing and diagnostic lab services in support of clinical trials research, toxicology, and individual patient care, ACM performs more than 30 million laboratory tests each year. “ACM was founded on the principle that research partnerships depend on unmatched expertise and an unwavering dedication to customer service and shared goals. Our experts have long-standing histories in patient care, allowing us to meet our customer goals with a vision of how they’ll impact patient lives for the better,” begins Thomas Mueller, Chief Commercial Officer, ACM Global Laboratories. “We bring in harmonization of a big lab with the adaptive and proactive approach of a smaller lab. Our central lab services include bioanalytical, advanced PK/PD, nicotine and research, cannabinoid testing, novel drug delivery, controlled substances, delayed release mechanisms, to name a few, along with flow cytometry, routine safety, testing pathology, biomarker testing, and also infectious disease like COVID-19 research.”

As the clinical trial landscape evolves, ACM prides itself on managing trials with increasing complexity, including studies with new and unique biomarkers, hybrid studies, and adaptive designs. The company provides scientific expertise and process management across the breadth of development, including end-to-end lab service solutions, kit creation, and delivery, sample tracking, chain of custody, logistics, and commitment to quality.

Over the years, with the aid of strategic alliances and global lab partnerships and support, ACM Global Laboratories has worked its way up to become one of the largest independent central labs in the industry specializing in high-quality central laboratory testing, toxicology, and diagnostic lab services. Apart from the expert bioanalytical services, unsurpassed central lab services, and reliable toxicology services, ACM’s uniqueness stems from its four winning differentiators: agility, flexibility, personalized service, and proven global expertise. Keeping pace with the recent trends and transformations, ACM remains agile— from supplies to services—to meet its clients’ diverse needs in a way that other companies cannot. The company’s global footprint and decades of successful clinical trial and rescue study experience have been instrumental in supporting diverse clinical trials programs worldwide. With this unsurpassed global service to customers in more than 65 countries, ACM has built a strong network that enables flexibility in executing clinical trials and extends beyond ACM Global facilities to include well-established relationships with trusted reference laboratories should the clients’ studies require additional support. As such, with wholly-owned laboratories and long-standing relationships with multiple, carefully selected partner laboratories, ACM seamlessly navigates the complexities of transporting samples and supplies globally by validating compliance with local regulations, managing couriers and shipments and providing shipping options that optimize cost, efficiency and reliability.

ACM also understands the importance of the standardization of laboratory tests in global clinical trials. According to Mueller, accurate and consistent data is key to ensuring the safe treatment of patients enrolled in trials and being essential to providing reliable statistical analysis of lab test results to provide robust, successful trial outcomes.

To ensure quality control and harmonization of lab results, ACM’s global laboratory teams perform global correlation studies on applicable tests to ensure comparability of results from all its laboratory locations. The teams also participate in independent proficiency analysis to verify continued performance and compare those results globally. Through this global management structure, ACM’s laboratory experts continually implement harmonized procedures and best practices to ensure inter-laboratory standardized testing practices and operating procedures for each of its sites.

Flexibility at its Best

ACM marks its prominence in the global clinical trials space with the quintessential flexibility and problem-solving skills coupled with its indomitable ‘can-do’ spirit to meet and exceed customer expectations. ACM acknowledges the fact that every clinical trial program needs to address unique specifications and challenges. To that end, the company partners with its clients to develop the fitting complement of technical and product management strategies that optimize their unique clinical development projects. ACM introduces a personalized touch to custom-tailored solutions from specimen collection and management, routine safety testing, global logistics to specialized laboratory services. At the outset, a typical client engagement at ACM begins with an in-depth consultative discussion with either the CRO or the sponsor running the study. Through this comprehensive discussion, ACM understands the specific therapeutic area the study deals in, the demographic, regions and sites it looks to target, the type of tests required to be run, the clinical test lit needed, and much more. “Once we understand the overall study design and protocol, we can deliver and execute on almost any proposal that we put forward. This consultative discussion right from the beginning of our engagement with the client ensures that our expertise and capabilities are aligned with their objectives,” states Mueller. At the core, ACM primarily caters to small to medium-sized pharmaceutical and biotechnology companies globally. “We believe that there’s a patient at the end of each study and every sample is vitally important in creating therapies in vaccines of the future. With that in mind, we try to remain flexible with our customers’ needs and offer a tailored approach, understanding that a rigid one-size-fits-all model does not work. We collaborate with each of our customers from beginning to end to ensure that we deliver an open and transparent service,” he adds.

Touching upon the recent trends in the clinical trial space, Mueller highlights the push toward remote and hybrid trials. While this trend continues to accelerate in the wake of COVID-19, ACM encourages adopting hybrid trials and has successfully met this demand in many different ways. For one, ACM includes development and support for custom in-field kits, which can be bifurcated for remote clinical trials and the remote nursing companies that support them. “Kit development is one area of operational excellence and cost-cutting that if done early can equate to better usage, better operational efficiencies and overall economy of the budget. These comprehensive and customized kits being delivered to remote nursing companies have all of the extra supplies that are needed,” he adds. These kits from ACM look like a mobile suitcase—with each patient’s supplies available, ready, and mobile to help meet that demand around hybrid trials. Besides, ACM also takes a data-driven approach to help manage clinical trials, which equips its clients with data transparency and accessibility about their problems, their samples, and their stand in that sample journey. Taking this a step ahead, the company has designed a unique client portal that offers 24/7 and 365-days access to data and test results. Using this portal, clients can reorder kit supplies at the site level and have managerial approval for site reordering to keep costs controlled for each of their clinical studies.

ACM was founded on the principle that research partnerships depend on unmatched expertise and an unwavering dedication to customer service and shared goals

A Testimony of Excellence

Putting theory into practice demonstrates several successful examples of ACM’s expertise in action. In many instances, the company has been approached by clients to conduct “Warp-Speed” clinical trials, which involves developing kits and getting them onsite in a rapid fashion. “With our flexibility and customer focus, we were able to quickly get on the phone, ensure that we secure the right number of supplies for the entire study, and expedited set up times to get kits onsite. This has contributed significantly to accelerate therapies and vaccines coming to market and execute on tight trial timelines,” informs Mueller. ACM leverages its rigorous supply chain process before accepting any study to ensure that kits’ onsite delivery date and replenishment of supplies throughout the study will be met. The company abides by a set of core values that enable the team to execute on timelines and ensure that every task is fully supported through disciplined execution and logistics management.

In a similarly impressive feat, ACM Global Laboratories was once approached as a central lab for a Phase 3 clinical trial of a new therapy for primary generalized tonic-clonic seizures (PGTCS). The primary study objective was to demonstrate the efficacy of the new treatment versus placebo as adjunctive therapy for uncontrolled PGTCS, with the secondary goal being the assessment of the safety and tolerability of the treatment in subjects with idiopathic generalized epilepsy (IGE) with uncontrolled PGTCS.

The globally conducted double-blind study aimed at evaluating the efficacy and safety of the treatment as adjunctive therapy for uncontrolled PGTCS in subjects with IGE. To lift the customers out of the doldrums, ACM facilitated the investigators’ ability to monitor patient safety through custom programming. Test methods included standard safety panels, HIV, Thyroid panel, and PDILI (Potential Drug-Induced Liver Injury) testing kits. In essence, seamless clinical integration and customized solutions from ACM paved the way for success. ACM developed customized testing solutions drawn from its portfolio of laboratory support services that allowed its scientists to develop and transfer methods accurately and efficiently to meet the clients’ The results of this trial were encouraging and successful, and the treatment was proven to be generally tolerated in patients with both IGE and PGTCS. This has led the U.S. Food and Drug Administration to approve it for use in the U.S.—an exciting development for those to whom the treatment will ultimately be administered to and an accomplishment for ACM Global Laboratories, its clients, and extended team members.

All Eyes on the Future

Problem-solving and attention to detail form the DNA of ACM. With Mueller leading all commercial efforts, the team members are constantly driven to be accountable first to themselves, live core values, and embrace a positive culture of growth and innovation to solve any size problems. With such leadership ethos in place, ACM puts the patient first at every step of the process, knowing the life-changing potential of clinical trial outcomes. This dedication to being purposefully patient-driven is reflected in the high-quality work provided by the team members every day around the globe.

On its way to script more success stories for its clients, ACM recently invested in a new molecular diagnostics lab, explicitly focusing on infectious disease, which currently aims to address COVID-19 and other contagious diseases in the future. Moving ahead, the company will continue to invest and innovate in inter-laboratory standardized testing practices and operating procedures for each of its sites to increase efficiency, accuracy, and ease of sharing data with customers now and into the future. “We pride ourselves in operating through a set of core principles; people, integrity, transparency and challenging the status quo are our priority. Our future is embodied with those principles to continue to challenge the status quo for us to not only meet the challenges of today, but also in decades to come,” concludes Mueller.