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Platform Overview

eClinical Supply Chain Management Platform

For collaboration, real-time visibility, traceable chain of custody, and compliance

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 trails.

The Slope eClinical Supply Chain Management platform fosters:
Collaboration between all collaborators including sponsors, CROs, sites, investigational product (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 collaborators
Traceable chain of custody for all biological samples, investigational products, and clinical supplies—whether stored or in transit
Compliance with the protocol, amendments, and federal regulations—including Title 21 CFR Part 11 GCP, ALCOAC, and Sunshine Act

Collaboration

Turn Your Clinical Trial Management into a Well-Oiled Machine

Manual processes make effective clinical trial management difficult for clinical operations (ClinOps) teams, clinical trial project managers, and research site coordinators.

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.

Using the Slope eClinical Supply Chain Management platform for your clinical supply chain management turns your clinical trial operations into a productive and effective machine.

  • Coordinates, orchestrates, and simplifies complex clinical trial protocols
  • Streamlines processes and communications across collaborators.
  • Puts operational coordination and control in the hands of clinical operations teams
  • Promotes cost-effective clinical supply orders across collaborators
  • Provides the data needed for improved resource planning for ClinOps, research sites, labs, biorepositories, and suppliers
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Collaborative Workspace

Communicate and coordinate activities between sponsors, research sites, vendors, labs, biorepositories, and couriers in a central, online space

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Subject Procedure Calendar

Enable demand-driven supply orders and shipments based on the timepoint procedures scheduled at each research site and the clinical supplies needed

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Procurement Management

Standardize purchasing processes and orders for IP, lab kit components, devices, biospecimen shippers, PPE, and ancillary supplies

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Shipping Management

Define clinical supply and biological sample shipping processes for all collaborators, and automatically print shipping labels and manifests

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Shipping Guardrails

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

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Shipping Notifications

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

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Data and System Integration

Track shipments from within Slope—pulling data from carrier tracking services—and share data with clinical trial data management and trial management systems

Real-time Visibility

Always Know What’s Happening with Your Clinical Trial and What To Do Next

No one knows how the clinical trial is progressing from site to site or lab to lab on any given day or week.

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.

By managing your clinical supply chain and clinical trial logistics through the Slope eClinical Supply Chain Management platform:

  • Sponsors have real-time insights into trial execution across locations with data they can trust
  • Research sites are prepared for every subject visit and always have what they need for the procedure at hand
  • More valid biological samples are collected using the right lab kits.
  • Resource needs across collaborators are forecasted for better planning and cost-effective clinical supply orders
  • Workflows and communications are streamlined across the clinical supply chain
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Clinical Trial Supply Management

Manage research site supply inventory, storage locations, expiration and recalibration dates, lot & serial numbers, use, disposal, loss, and returns

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Supply Order Tracking with Audit Trails

Know when resupply orders are needed, the exact quantity needed based on scheduled subject procedures, and who placed the resupply order when

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Site Activities Across Locations

See past, present, and future subject procedure schedules, drug dispensing and reclamation, lab kits used, and biological samples collected & shipped

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Replenishment and Shipment Alerts

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

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Single System of Record for One or More Studies

Maintain a single version of truth across collaborators for lab kit, IP, and ancillary supply, inventories, and biological samples collected, shipped, and stored

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Real-time Dashboards and Monitoring

View persona-based dashboards and reports at any time, with up-to-the-minute data for the activities and items each collaborator cares about

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Accessible Anywhere, Anytime, from Any Device

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

Traceable Chain of Custody

Maintain an Audit Trail for the Who, When, and Where of Possessed IP, Biological Specimens, and Clinical Supplies

Any knowledge gap in a biological specimen's lifecycle breaks its chain of custody, resulting in invalid or lost samples, questionable data integrity, and compliance challenges.

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.

The Slope eClinical Supply Chain Management platform maintains a “digital twin” for every physical item used in a clinical trial, which ensures traceable chain-of-custody for IP, biological specimens, lab kits, and ancillary supplies whether in use, in transit, or in storage—across vendors, sites, subjects, couriers, labs, and biorepositories, resulting in:

  • Fewer lost and spoiled biological samples
  • Trustworthy data that smooths the compliance process
  • Streamlined workflows for registering and tracking every item
  • Standard biological sample management processes across collaborators
  • Better communication and coordination while tracking IP, biological specimens, lab kits, and ancillary supplies
  • Increased protocol and amendment adherence
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Biological Sample Tracking

Always know when a new biospecimen sample is collected, registered, shipped, routed, received by a lab—and its condition upon arrival

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Automatic Lab Notifications

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

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Data-enabled Smart Lab Kits

Simply scan to log lab kit use and biological sample shipment, receipt, and storage, with barcode labels that make traceable chain of custody easy

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Drug Accountability

Track the routing, storage, handling, and consumption of investigational product—and document IP administration, reclamation, and destruction

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Audit Trails

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

Compliance

Assure Regulatory, Protocol, and Amendment Compliance throughout Your Clinical Trial

Dependence on collaborator personnel at different organizations to communicate, encourage, and institutionalize protocol and regulatory compliance introduces clinical trial risk.

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.

Slope eClinical Supply Chain Management platform delivers protocol, amendment, and regulatory adherence through structured workflows and audit trails that:

  • Put operational coordination and control in the hands of the clinical operations team across collaborators
  • Reduce protocol and amendment deviations that result in invalid samples for reasons such as using the wrong lab kit
  • Encourage good clinical practices and regulatory compliance across research sites and the clinical supply chain as a whole
  • Make it easy to generate the data and materials needed to pass an audit
  • Create data with integrity that auditors can trust
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Configured to Study Protocols

Embed the lab, pharmacy, and operations manuals and any amendments into the Slope eCSCM platform so that processes and expectations are clear

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Protocol-based Workflows

Define standard processes for lab kit design, configuration, and fulfillment; each timepoint sample collection, processing, shipping, and storage; and IP dispensing

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Multiple Live Amendments

Run different amendments at different research sites concurrently for harmonious amendment management across research sites

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Role-specific Privileges

Ensure the integrity of your data with different access privileges for clinical operations, research sites, pharmacy staff, lab technicians, and inventory managers

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Regulatory Compliance

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

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Audit Support Materials

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

Start optimizing your Clinical Supply Chain Management today

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