The Slope eClinical Supply Chain Management (eCSCM) platform provides a collaborative workspace to define protocol-specific workflows and processes to guide supply procurement, inventory management, and biological sample collection, shipping, routing, and tracking.
Slope uses these guided workflows alongside real-time demand data at the research site and patient level to orchestrate the operational execution of complex study protocols. All actions are logged in a central source of truth to provide complete audit trials.
Using spreadsheets, emails, phone calls, and written protocol manuals to coordinate and communicate with sponsors, sites, investigational product (IP) suppliers, lab kit and ancillary supply vendors, labs, biorepositories, and couriers is time-consuming and prone to error. No wonder 70% of clinical trial supplies expire or go unused, wasting precious clinical study budgets.
Communicate and coordinate activities between sponsors, research sites, vendors, labs, biorepositories, and couriers in a central, online space
Enable demand-driven supply orders and shipments based on the timepoint procedures scheduled at each research site and the clinical supplies needed
Standardize purchasing processes and orders for IP, lab kit components, devices, biospecimen shippers, PPE, and ancillary supplies
Define clinical supply and biological sample shipping processes for all collaborators, and automatically print shipping labels and manifests
Make sure IP and biological samples are shipped in the correct shipper, packaged properly, and sent to the correct destination at the right time for receiving
Automatically notify sponsors that shipments went out, notify sites that supplies are coming, and notify labs and biorepositories that biospecimen samples are on their way
Track shipments from within Slope—pulling data from carrier tracking services—and share data with clinical trial data management and trial management systems
Everyone works with information received after the fact through a data transcription process from spreadsheet to spreadsheet or from system to system—a process that introduces errors.
As a result, sponsors lack insight into what is going on across collaborators on any given day or coming week, and don’t know where their IP and biospecimen samples are. Research sites don’t know what supplies they have, where they are, or how they got there. And no one trusts the resulting data.
Manage research site supply inventory, storage locations, expiration and recalibration dates, lot & serial numbers, use, disposal, loss, and returns
Know when resupply orders are needed, the exact quantity needed based on scheduled subject procedures, and who placed the resupply order when
See past, present, and future subject procedure schedules, drug dispensing and reclamation, lab kits used, and biological samples collected & shipped
Recieve auto-alerts when IP, lab kit, and supply inventory need to be replenished, when orders are placed, biological samples and supplies shipped, and any delays
Maintain a single version of truth across collaborators for lab kit, IP, and ancillary supply, inventories, and biological samples collected, shipped, and stored
View persona-based dashboards and reports at any time, with up-to-the-minute data for the activities and items each collaborator cares about
Stay up to date and keep activity logs up to date by accessing all Slope capabilities from your computer, laptop, mobile phone, or tablet—at anytime, anywhere
Valid biological samples are critical for clinical trial outcomes, yet the manual, paper-driven processes used to track lab kits and biospecimens through the different stages of their lifecycle create significant risk for the trial outcome.
Without proper biological sample management from stage to stage, biospecimens can be lost or deemed invalid for use. Without proper biological sample management, the integrity of clinical trial data can be questionable, resulting in compliance issues.
Always know when a new biospecimen sample is collected, registered, shipped, routed, received by a lab—and its condition upon arrival
Prevent precious biological from samples from spoiling on a loading dock when no one is there to receive them, with automatic notifications to labs that samples are incoming
Simply scan to log lab kit use and biological sample shipment, receipt, and storage, with barcode labels that make traceable chain of custody easy
Track the routing, storage, handling, and consumption of investigational product—and document IP administration, reclamation, and destruction
Automatically create audit trails that document and attest to the chain of custody for IP, biological specimens, lab kits, and ancillary supplies throughout their lifecycle
Research sites, labs, and suppliers have different methods of defining workflows that support each protocol and the collection and reporting of relevant data, leaving the sponsor with little or no control. The fact that amendments go live at different research sites at different times complicates things further.
Deviations are bound to occur without standard, protocol-based workflows with guardrails that ensure protocol and regulatory compliance across research sites.
Leaving each site to interpret and determine how they drive protocol adherence and regulatory compliance makes preparing materials for a time-intensive effort that occurs after the fact and results in data that may not be complete or correct.
Embed the lab, pharmacy, and operations manuals and any amendments into the Slope eCSCM platform so that processes and expectations are clear
Define standard processes for lab kit design, configuration, and fulfillment; each timepoint sample collection, processing, shipping, and storage; and IP dispensing
Run different amendments at different research sites concurrently for harmonious amendment management across research sites
Ensure the integrity of your data with different access privileges for clinical operations, research sites, pharmacy staff, lab technicians, and inventory managers
Collect your data in the Slope Title 21 CFR Part 11-compliant platform to attest compliance with Good Clinical Practice, ALCOAC, and the Sunshine Act
Have audit trails and documentation at the ready for all actions taken, subject procedures conducted, biospecimens collected, and lab kit and sample chain of custody