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July 19, 2022

Slope Appoints Clinical Research Veteran Hope Meely as Slope Chief Clinical Officer

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Slope
Meely To Drive Digital Transformation of Clinical Supply Management for Complex Clinical Trials

San Francisco, CA — July 19, 2022 — Slope, provider of the first eClinical Supply Chain Management (eCSCM) platform, announced hiring the clinical research leader, Hope Meely, as Chief Clinical Officer. In her new role, Hope will be instrumental in educating the industry on the new eCSCM software as a service (SaaS) category. Hope will help clinical trial sponsors and research sites understand how replacing existing manual and paper-driven clinical supply chain processes with the Slope eCSCM platform will reduce clinical trial risk and costs, improve the productivity of clinical trial collaborators, and increase subject retention.

“One of the biggest challenges we face as an industry is ensuring that lab kits, investigational products (IP), devices, ancillary clinical supplies, and biological samples get to the right place, at the right time, in the proper condition,” said Hope. "While we have digitized other aspects of our clinical trial functions with EDCs [electronic data capture], CTMSs [clinical trial management systems], IRTs [interactive response technologies], and other systems, we have not had anything to proactively track and manage our clinical supply chain or reconcile our biological samples backward from biorepository storage, to laboratory, courier, research site, lab kit distributor and manufacturer. The Slope platform gives us all of that.”

“In addition to her decades of experience in various clinical research positions—from data manager to project manager, clinical trial leader, and vice president of clinical operations at companies large and small—she has spent the past 3 years as a Slope customer leading clinical operations,” said Rust Felix, Slope CEO and cofounder. “The depth and breadth of her expertise and knowledge, along with her continued interactions with the industry as a whole, will help inform our company and product direction to meet the critical need for better data-driven clinical supply chain management.”

More About Hope

Hope started her career as a data manager at GlaxoSmithKline. From there, she became a clinical trial leader and senior project manager for companies such as Johnson and Johnson, AstraZeneca, Sanofi, Takeda Pharmaceuticals, and Pharmaceutical Product Development, a clinical research organization. Hope has spent the last three years leading clinical operations for early-phase oncology clinical trials at Prelude Therapeutics. Throughout her career, she has demonstrated passion for adopting innovative technologies that make clinical trial programs and studies more efficient. Connect with Hope on LinkedIn.

You can hear Hope live as she participates in the industry panel “Solutions to Today's Clinical Data Challenges—Delayed Data and Its Impact On Your Clinical Trials: Insights and Analysis from the encapsia industry survey 2022” on July 28th at 11 AM EST. Register here.

For More Information

More About Slope

Slope is the first provider of an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-phase clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention. Through its Title 21 CFR Part 11-compliant platform and protocol-specific guided workflows, Slope fosters collaboration between sponsors, sites, vendors, labs, biorepositories, and couriers; provides real-time visibility into activities at research sites; ensures traceable chain-of-custody for supplies and samples in use, transit, and storage; and contributes to stronger compliance and protocol adherence. To date, Slope has managed over a million supplies for hundreds of studies across thousands of sites.

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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 distributor 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, distributors, 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.