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Solutions Platform OverviewFor Clinical Research SponsorsFor Clinical Research Sites Company AboutLeadershipPress ReleasesIn the NewsEventsCareers Blog Sign in Contact SLOPE SUPPORT Get help directly in the Slope app — just click the button on the bottom right ✕ SUPPLY CHAIN MANAGEMENT For Clinical Trials Take the chaos out of your clinical trial operations with the Slope eClinical Supply Chain Management platform For Sponsors & CROs Clinical Supply Chain Coordination & Orchestration FREE for Research Sites Clinical Supply Inventory Management TODAY’S CLINICAL TRIALS ARE INCREASINGLY COMPLEX Many dynamic, moving parts go into the execution of a clinical trial—the protocol, amendments, patient visit schedules, different procedures at different timepoints, Investigation Product (IP), lab kits, clinical supplies, biological samples, and shippers—creating logistical challenges that reduce productivity, increase costs, cause subject attrition, and threaten the overall success of the clinical trial. 70% more procedures 60% more research sites 85% more endpoints 2.3 amendments per protocol 88% more data points collected 6.9 protocol changes per amendment MANY PLAYERS CONTRIBUTE TO CLINICAL TRIALS There are many contributors to a successful clinical trial that keep everything moving—each with its own processes, hours of operation, systems, best practices, goals, and priorities. Keeping everyone working together effectively so that subjects have a positive experience takes a lot of coordination and communication—and it's difficult to prevent balls from dropping. Clinical Operations Team Clinical Research Sites Clinical Supply Vendors IP Suppliers Labs Biorepositories Couriers Auditors Introducing the Industry's First ECLINICAL SUPPLY CHAIN MANAGEMENT (ECSCM) PLATFORM FOR COMPLEX, SAMPLE‑INTENSIVE, EARLY‑STAGE STUDIES Slope provides a collaborative workspace, configured specifically for your protocol with predefined workflows and processes for supply procurement and shipping, inventory management, subject procedures, and biological sample collection and processing. Slope then uses clinical supply demand data captured at the patient level alongside real-time data and guided workflows to orchestrate the operational execution of complex study protocols. All actions taken are logged in a central source of truth for you, your investigators, and auditors. COLLABORATION & CONTROL Between all the collaborators—sponsors, sites, IP suppliers, supply vendors, labs, biorepositories, and couriers REAL-TIME VISIBILITY Into trial execution and the location and status of all clinical supplies and biological samples across all collaborators TRACEABLE CHAIN OF CUSTODY For all biological samples, investigational product, and clinical supplies whether stored or in transit between collaborators COMPLIANCE & ADHERENCE To the protocol, amendments, and federal regulations including Title 21 CFR Part 11 GCP, ALCOAC and Sunshine Act OPTIMIZE THE CLINICAL SUPPLY CHAIN FOR YOUR CLINICAL RESEARCH STUDY MINIMIZE RISK FOR YOUR CLINICAL TRIAL Take control of your clinical trial and know what is going on with your supplies, biological samples, subject procedures, and collaborators on a day-to-day basis, so there are no more surprises. Better Data Integrity Real-time Insights into Trial Execution Protocol and Amendment Adherence Regulatory Compliance Operational Coordination and Control REDUCE CLINICAL TRIAL COSTS Make the most of your budget by standardizing supply purchases and operationalizing lab kit reorders, so that every biological sample collected adheres to the protocol and counts. Increased Valid Samples Reduced Supply Waste Cost-effective Supply Orders Improved Resource Planning IMPROVE PRODUCTIVITY Get your collaborators on the same page and working consistently, correctly, and efficiently with best-practice workflows and processes that you define, control, and track. Streamlined Workflows Stakeholder Coordination Standard Processes Streamlined Communications INCREASE SUBJECT RETENTION Keep your valuable clinical trial subjects participating by making sure research sites are prepared for every visit, have the right lab kit for each procedure, and ship samples so they don’t get lost or spoil. Sites Have What They Need When They Need It Sites Prepared for Every Visit Reduction in Lost Biological Samples Reduction in Spoiled Biological Samples Platform Overview RESEARCH STUDY SPONSORS Learn how to make your clinical trial boring → RESEARCH SITE COORDINATORS Learn how to make your days worry-free → START OPTIMIZING YOUR CLINICAL SUPPLY CHAIN MANAGEMENT TODAY Request a Meeting & Demo LATEST NEWS Read more → September 23, 2022 Compliance Requirements for an eClinical Supply Chain Management Platform Protocols are becoming increasingly complex, and many require multiple amendments, making protocol adherence more challenging for clinical trials. In addition, federal regulations and best-practice guidance are constantly being updated. Without automated support for communicating, coordinating, and controlling collaborator processes, sponsors cannot ensure that research sites and other collaborators are adhering to the protocol. This also applies to regulatory requirements and good clinical practice (GCP) guidance. As a result, required safety checks might be missed, biological samples might not be collected, handled, shipped, or processed according to the protocol, and regulatory requirements and guidance might not be followed. This can cause subjects to drop out due to negative experiences, or the elimination of subjects due to protocol deviations, which can risk the clinical trial’s overall success. September 22, 2022 Slope Listed as a Sample Vendor in Gartner® Hype Cycle™ for Life Science Clinical Development, 2022 for Clinical Trial Resource Management Slope, provider of the first eClinical Supply Chain Management (eCSCM) platform, announced that it has been identified as a Sample Vendor in the 2022 Gartner Hype Cycle for Life Science Clinical Development, 2022. Slope was named in the Clinical Trial Resource Management category. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, and early-phase clinical trials in areas such as oncology, gene therapy, and rare disease. August 26, 2022 Traceable Chain of Custody Requirements for an eClinical Supply Chain Management Platform Biological samples from subjects are the most valuable assets that travel across the clinical trial’s supply chain. Any gap in the knowledge in the biological sample's lifecycle can make the subject non-evaluable and jeopardize overall data integrity. If this happens too often, the overall clinical trial can be at risk. When shipping biological samples, clinical research sponsors must have the data they need to conduct biological sample reconciliation—meaning they have documentation to track a biological sample stored in a biorepository back to the lab that analyzed it, the courier that transported it, the research site that collected it, the lab kit that was used and its lot and serial number, and the lab kit’s supplier and manufacturer. This data allows the sponsor to prove that a biological sample is valid and has not been tainted anywhere along the way. As a result, an online platform must maintain an immutable record of all of the steps a biological sample takes throughout its journey from collection through storage, along with the steps taken by each collaborator, including sponsors, contract research organizations (CROs), research sites, suppliers, labs, and couriers. As a result, an eCSCM platform must be able to prove a traceable chain of custody for biological samples, lab kits, investigational product (IP), devices, and ancillary and other clinical supplies, whether in use, transit, or storage. SUBSCRIBE TO OUR BLOG AND GET THE LATEST NEWS IN YOUR INBOX. Email Address Thank you! Your subscription request has been sent! That didn't work Please try again Mailing Address Slope Supply Depot 548 Market Street, Suite 21103 San Francisco, CA 94104 11551 Nuckols Road, Suite M Glen Allen, VA 23059 Follow us on LinkedIn Platform Company Resources Get Started OverviewSponsorsSites AboutIn the NewsCareers Blog Support ContactSign in All Rights Reserved © 2022 Slope.io, Inc. Terms of ServicePrivacy Policy Cookies Notice We use cookies to improve your experience on this website and to measure website usage. By continuing to use this website, you consent to these cookies. For more information, please view our Privacy Policy. Accept