Slope Resources

As precision medicine demands more complex study designs, static lab manuals and traditional methods for biospecimen management introduce serious risks. This white paper sheds light on the lab manual’s current role in sample management, the inherent pitfalls of traditional approaches, and the ways in which sponsors can leverage technological innovations to standardize research site practices and optimize compliance across all of their trials.

Oncology clinical trial participants are required to contribute various biological samples — such as blood, saliva, and tissue — to demonstrate how a study drug could potentially affect their disease.

Clinical research sites are at the heart of clinical trials, however technology designed to support trial operations has overlooked a fundamental problem at the site-level: 75% of clinical research sites still manage their clinical inventory on paper and spreadsheets. Research sites lack visibility and control over the supplies sent to them, leading to a labor-intensive process that prevents clinicians from spending more time with their patients, or on activities that could enable them to be reimbursed. This white paper explains why real-time inventory management should be everyone’s objective.

A site-centric clinical trial execution platform for managing inventory and biospecimens can dramatically improve compliance, efficiency, and visibility to the entire sample journey. This white paper sheds light on the lab manual’s current role in sample management, the inherent risks and challenges with traditional approaches, and the ways in which research sites can leverage technological innovations to completely revamp their operations across all of their studies.

As clinical researchers, your first responsibility is running your clinic and treating your patients. You care that supplies are available for your patients and that critical safety, efficacy, and exploratory lab samples get where they need to be. You understand the impact of lost or invalid samples on the patient and the repercussions improper sample management has on the safety and efficacy data and the overall integrity of your study. We’ve created this guide to help you better manage your samples and gain control over your supply chain while focusing on your core responsibilities around your clinic and your patients.

As a sponsor, you face numerous obligations when executing clinical trials, with the primary goal of gathering sufficient data to demonstrate the safety and efficacy of investigational products or devices. The data you collect must be defensible and complete, and biological samples represent a critical source of that data. Therefore, to successfully execute a clinical trial, the sample management process also needs to be defensible and complete. It is crucial to have visibility into the entire sample journey, as it demonstrates protocol compliance and sample traceability. Lost or mishandled samples can significantly impact research sites, patients, data integrity, and study timelines.

Upgrading from disparate manual processes to a unified digital platform for managing inventory, Gabrail Cancer Center was able to reclaim hours of staff time each week, reduce lab kit waste by more than 20% across all of its studies, and enhance its collaboration with study stakeholders.

As an epicenter for clinical research in the Mid-Atlantic, this large, world-renowned academic medical center (AMC) is a bustling hub for lab kits and other supplies. The dilemma, however, was that they did not have an efficient logistical infrastructure to support the high volume of inventory that was circulating through their disease centers. Leveraging a centralized, comprehensive inventory management platform translated to better accountability of lab kits, waste prevention, and more informed decision-making.

This emerging biotech was facing operational difficulties within its Phase 1 Oncology programs because of its complicated designs and sample requirements. Each study had an intricate network of clinical sites, a detailed clinical sample schema, multiple external sample destinations, and required shipping conditions. This was compounded by economic pressures and supply chain inefficiencies during the COVID pandemic. Read the case study to learn how this organization saved over $300k by leveraging Slope's clinical trial execution platform.

Sponsors who are at the helm of clinical trial operations are responsible for crafting a robust monitoring strategy for every clinical trial. Part of their mission is to implement plans and solutions that safeguard patient well-being, ensure the accuracy and completeness of trial data, and facilitate compliance with both currently approved study documents and regulatory requirements.The reality is that the modern landscape of clinical research makes monitoring a daunting task. This e-book explores the ways in which you can optimize your clinical trial monitoring strategy to boost research site compliance.

Sponsors recognize that successful end-to-end sample management is crucial to developing new therapies, but the growth in clinical research — combined with increasing complexity of study designs — has exacerbated inconsistent and outdated approaches to sample management.

Slope transforms study execution by connecting systems and study stakeholders to direct site operations and drive real-time, traceable, and operational clinical data. By syncing information across vendors and eClinical systems including EDC, IRT, LIMS, shippers, and other systems, critical data surrounding inventory and sample management becomes accessible and actionable anytime — strengthening data integrity, empowering decision-making, and accelerating clinical research timelines.

Matt Smith, Slope’s VP of Research Site Development, recently presented at #FOB2023 on the topic of value-based study planning as a way to improve site and sponsor experiences. The presentation sparked an energized conversation around the high value we place on study start-up, while other important focus areas that directly impact a trial’s success further downstream remain overlooked.

Clinical trials are operationally burdensome. Regulatory requirements are expected, but unclear. The importance of biospecimens is increasing, and regulatory risk grows with biospecimen importance. In this presentation, Slope's Chief Clinical Officer, Hope Meely, explains the many hidden regulatory risks in biospecimen management, and shares key strategies to achieve proactive regulatory risk-proofing.

Slope's inaugural State of Clinical Inventory and Sample Management survey gathered insights from 146 biopharma professionals on the impacts of inefficient, manual processes for managing clinical supply — lab kits, devices, ancillary supplies, and investigational product (IP) — and samples on budgets, timelines, data integrity, and patients. Download the survey report to learn more about these surprising findings.

Alex Yant is a Solutions Engineer for Slope, the industry’s first Clinical Trial Execution platform. He works to add order, trust, and predictability to your clinical research trials, so they end on-time and on-budget. Alex has four years of healthcare experience, as both clinical research professional and a direct service provider. He holds a bachelor’s degree from the University of Wisconsin-Madison, and a Master of Science in Occupational Therapy from the University of Illinois at Chicago. In this episode we discuss the significance of diversity of experience in clinical trials, the role of sites in clinical trial inefficiency, and the complexity of managing site lab inventory.

Ethan Seville is a clinical research professional who has worked in a wide range of indications across various roles such as patient recruitment, coordinating, quality assurance, management, and regulatory. Ethan is now the Manger of Customer Engagement and Strategic Solutions for Slope.io, which helps researchers by ensuring their network of clinical trial patients get the exact medical supplies their care requires on time, on schedule and on budget. In this episode, Ethan interviews Brad.