What We Do

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.

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.

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.