SmartView Clinical Trial Module

SmartView Clinical Trial Module

Cold Chain Data Analytics Cloud Software

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Handling

Reduce admin time, manual handling and associated risks.

Excursion management

Reduce the risk for dispensing drugs potentially affected by a temperature deviation.

Audit

Be prepared in no time with all temperature data available in one system.

Patient

Reduce failed patient visits and increase patient safety.

Product modules

Module Overview

SmartView Basic Business Logic

Shipment Monitoring

Shipment Monitoring

Shipment Monitoring

Shipment Monitoring
Shipment Monitoring

Manage excursions in SmartView

Get detailed information about the temperature development during a shipment in order to support decision-making if actions are required. Key deliverables:

  • Creation of a shipment with comprehensive metadata
  • Association of temperature devices to a shipment
  • Upload of device data with e-mail notification highlighting number and details of excursions
  • Device PDF document includes temperature graph with device alarms converted to SmartView excursions
  • Management of temperature excursions
  • Download of shipment PDF report including important information such as metadata, graph, excursions, statistics, excursion management and measurements
SmartView Clinical Trial Brochure
Shipment Analysis

Shipment Analysis

Shipment Analysis

Shipment Analysis

Analytics dashboards with downloads

Analyze multiple shipments in parallel to identify weak points and find levers to improve shipment quality. Key deliverables:

  • Access to shipment dashboard with easy-to-read graphs and pie charts
  • Customizable dashboards through the use of data filters
  • Creation of shipment analysis to analyze selected shipments in detail
  • Downloadable dashboard content as digital images or PDF files
  • Downloadable shipment analysis as a PDF report
Shipment Attachment Upload

Shipment Attachment Upload

Shipment Attachment Upload

Shipment Attachment Upload

Upload files to keep the overview

Monitor multiple shipments in parallel by using the attachment uploads feature. Key deliverables:

  • Upload PDF files as attachments to shipments (limit on quantity)
  • Inclusion of a description for uploaded attachments
  • Deletion and replacement of attached documents
Facility Monitoring

Facility Monitoring

Facility Monitoring

Facility Monitoring

Event profile with thresholds for warnings and alarms

Get notified as soon as temperature deviations occur in cold storage facilities so that immediate actions can be taken. Key deliverables:

  • Creation of location with one or multiple sectors representing the storage facility
  • Association of devices to sectors
  • Definition of an event profile with threshold for warnings and alarms triggering notification and escalation notification recipients
  • Definition of sector and device offline notification rules including notification recipients
  • Notification recipients receive temperature graph, statistics, excursions and delivery rates of the devices
  • Visualization through temperature graph, statistics, excursions and delivery rates of the devices
  • Creation of a sector PDF report including graph, statistics and excursions

SmartView Extended Business Logic

Product Stability Data

Product Stability Data

Product Stability Data

Product Stability Data

Define thresholds for temperature values

Get notified when temperature deviations are exceeding product-specific thresholds
so that immediate actions can be taken on the drug kit level. Key deliverables:

  • Definition of thresholds for temperature values in up to 8 rules for products
  • Product stability rules can be defined as a single or as an accumulated alarm
  • Definition of violation notification recipients via email
  • User email notification when product stability data check is violated
  • A system can receive stability data rule violations via webhook (only when API is enabled)
Clinical Trial

Clinical Trial

Clinical Trial

Clinical Trial

Find all relevant data quickly

Dedicated clinical trial container for each clinical trial to ensure quick access to all clinical trial-related information. Key deliverables:

  • Creation of a clinical trial container for user-defined metadata
  • Easy identification of clinical trial TCI associations via dedicated tab
  • Download PDF report related to a specific clinical trial TCI
  • Download PDF report or CSV file relating to all TCIs of the clinical trial
Temperature Controlled Item

Temperature Controlled Item

Temperature Controlled Item

Temperature Controlled Item

Manage temperature-controlled items via API

Monitor specific items through the complete cold chain even when multiple activities or device associations are involved. Key deliverables:

  • A 3rd-party application can create and manage TCIs via API
  • Activity graphs are combined over the life cycle of the TCI
  • Overview of TCI activity history via dedicated tab
  • Visualization of a combined TCI activity graph provides a start-to-end overview
  • Monitoring time statistics available for combined activities
  • TCI excursion information available via dedicated tab
  • A user can create a basic TCI PDF report

SmartView API Integration

Seamless Integration: SmartView API

Seamless Integration: SmartView API

Seamless Integration: SmartView API

Seamless Integration: SmartView API

Easy integration between ERP or Customer Software and SmartView to avoid redundant work and improve efficiency

As a user, I want to share information between my software environment and SmartView to reduce redundant work and increase speed, efficiency and quality. Key deliverables:

  • Configure your environment to decrease human intervention
  • Automatically set up and manage shipment and location monitoring
  • Integrate the setup and monitoring of individual items to be tracked throughout your cold chain
  • Integrate automated escalations in your system whenever product stability of a TCI has been violated
  • A site administrator can create dedicated API users (3rd-party applications) for API integration
Check out our solution

Challenge to solve

SmartView Clinical trial modules

“As a clinical trial sponsor, I want drug kits to be quarantined as soon as temperature deviations exceed defined product stability rules.”

SmartView Clinical Trial Module
1.

Site Monitoring Solution (Depot -IRT)

The key of the SmartView Clinical Trial Solution is to provide a full cumulative, end-to-end temperature profile for each drug kit. Building up the temperature history starts at the depot. At this stage, the temperature logger is associated with the drug kit by the IRT. The recorded temperature profile for each drug kit is being uploaded to the IRT and exchanged with Berlinger SmartView. Excursions and to what extent the stability budget is being consumed is recorded and the responsible person (e.g. QP) can be notified instantly.
SmartView Clinical Trial Module

Key Benefits

Quality improvement

Be notified when temperature deviations exceed product stability rules.

Integrated solution - your IRT remains front face

Take advantage of the Berlinger SmartView API. Full insights available in SmartView for QA in-depth reviews.

Partnership

Partnership with the most renowned IRT providers, CROs and CDMO’s.

Patient safety

Fast decision-making based on full insight increases patient safety.

The Berlinger Team is here to provide you with more information and answer any questions you may have. We will be pleased to advise you.

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