There is no cookie-cutter one-size-fits-all clinical trial. Each study protocol operates on an extensive blueprint, with a goal of researching and evaluating the risks and benefits of new drugs and other therapeutic treatments, utilizing a vast array of materials and resources. These elements can vary depending on the sponsor, therapeutic area and hypothesis, which is why enlisting experienced partners who offer end-to-end support in the clinical trial process is paramount to a successful trial, be it an exploratory FIH (first in human) initiative or pivotal trial.
Timeline, logistics, budget. Those are the three main factors in driving a clinical trial from inception to completion.
With the objective of gaining regulatory approval of a new drug, a trial must make its way through five complex “phases” - where each phase aims to answer a different set of questions.
Volunteer numbers and patient specimen collections increase in each phase of the trial progression, and a case is built to prove the experimental drug or treatment is effective and safe against the disease or condition it is intended to treat.
When navigating the clinical trial process, it’s imperative to choose a central lab partner with experience in overcoming a wide range of challenges during every phase of the clinical trials journey.
Thousands of patients, thousands of samples. The pharmaceutical industry is undoubtedly one of the most dynamic from an R&D perspective, with hundreds of new therapeutics entering the market every year, each undergoing a rigorous process and path to approval.
Whether the study requires a mix of routine safety, flow cytometry, microbiology, pathology or bioanalysis, a central laboratory like ACM is uniquely, and globally positioned to maximize investments and streamline projects.
Advancements in technology, expertise and dedication from countless organizations across the globe have changed the financial forecast of clinical trials over the course of a decade. The true cost of clinical trials will continue to be a contentious topic, so we dove into a few contrasting findings to get a better look at what CROs and sponsors might expect to invest.
Trial costs, timelines and logistics will also vary depending on the therapeutic area, as treatments vary from topicals to infusions, and other intensive treatments. The increased cost of goods and services will also undoubtedly continue to tax the industry, as well as ever-changing regulations. A study published by JAMA International Medicine in 2018 found that out of 138 pivotal trials assessing 59 new therapies that received FDA approval (between 2015 and 2016), there was a more than 100-fold difference in the cost of clinical trials.
The rise of consolidated CRO-giants has changed the market landscape, and because of this, sponsor companies need to be even more vigilant in their planning. It’s difficult to put a price tag on developing life-saving therapeutics to treat patients around the world, however, there are ways to mitigate surplus expenditures.
Knowing some of the key drivers of clinical trial complexity, the experienced team at ACM Global Laboratories can jump in to help support any study at any stage as the dedicated central lab. Execution matters, and we’re here to provide actionable clinical insights on a global scale.
Each clinical trial program must be customized to address unique specifications and challenges. By partnering with ACM Global Laboratories, our scientific experts, project managers, and other professionals are available to help our clients obtain the information needed to make data-driven decisions about any clinical trial program.
From the Request for Proposal (RFP) stage to results reporting on an approved therapeutic, partnering with a dedicated and experienced central lab can make all the difference in a smooth trial. At ACM Global Laboratories, we have almost four decades of experience supporting trials of all sizes and complexities and are often recruited to rescue studies in progress that have gone off-track.
ACM works as an extension of your team to understand the specific testing requirements and intricacies of your study. We'll help plan the optimal study and test menu design, anticipate an array of needs and respond quickly to requests. This approach provides complete transparency throughout the process, so clients are assured of the relevance, accuracy and timeliness of your testing data.
We offer the full range of central laboratory services, using the most up-to-date and appropriate testing options to ensure we deliver the assay endpoints your study requires. Our test menu features tests spanning nearly all medical disciplines, including routine safety testing, pathology, biomarker analysis, bioanalytical services, flow cytometry and immunoassays, toxicology and COVID-19 research.
Our laboratories are compliant with global GCP guidelines including but not limited to FDA, ICH, MHRA, MOH. We strive to produce the highest quality results for your trial and pride ourselves on continuous improvement to ensure global best practices for the industry. Our IT systems are 21CFR Part 11 compliant to ensure the utmost security for your data. If we partner with another laboratory to help you run additional esoteric testing, we ensure all of our partners adhere to the same quality practices we demand of ourselves. Through monitoring and internal and external auditing practices, you can be assured that ACM and its partners are here to deliver the highest quality results able to be obtained in the industry.
As part of ACM’s ongoing promise to clients to maintain transparency and never over-promise, a dedicated team oversees all logistical aspects of specimen collection delivery and storage. This team has put a host of measures into place, especially over the last year, to quickly and efficiently mitigate logistical delays.
One such measure is to train our client sites on how to properly pack shipments – especially those shipments that require dry ice. The team also monitors and tracks shipments on a daily basis, including all late shipments. Any shipment issues are immediately mitigated by working with the shipping service provider, such as FedEx.
Since 1975, ACM Global Laboratories has been a recognized leader in global clinical trial testing services. Through wholly-owned facilities and partner laboratories, we support clinical trials in more than 65 countries around the globe.
Learn more about how we can support your next trial and contact us today.