Fusion eClinical Suite Integrated Modules

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Axiom delivers an easy to use & cost-effective unified eClinical solution that is focused on small to medium sized biotech, device and CROs. Axiom’s technology eliminates the labor intensive manual tasks so often required by smaller companies in managing a clinical study or study platform.

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Electronic Data Capture

Fusion eClinical Suite
rapidAxiom Fusion eClinical Suite is a powerful, intuitive, and cost effective unified eClinical platform for managing clinical studies and registries.

Access real-time information across the global footprint of your study, including deviations, inventory tracking, randomization and payment tracking.

Eliminate manual processes and common data issues.  Run a more compliant study and see more real time, integrated information and insight into study activities and issues, allowing for timely action to resolve problems and keep studies on track.

Key Features

  • Live access within 10 business days while we build the study database
  • Unlimited, No-Fee Changes during Database Build
  • No per user/per seat fees
  • Powerful query & data management tools
  • Rapidly configured & deployed in weeks
  • Up to 24/7 Customer Care

Reporting Portal

Over 30 Real-time Project Management Reports

View key study indicators, review clinical reporting, access real-time, integrated information and insight into study activities and issues for timely action to resolve problems and keep studies on track. Use drag and drop tools to create your own custom reports. 

Reporting Portal graphicKey Features

  • Access real-time data about your entire study in two clicks
  • Choose from over 30 standard reports
  • Project Management Reports
  • Clinical/Benchmarking Reports
  • DSMB Reporting
  • Custom reports can be easily created and reused for future studies using the configurable report builder

 

Query/Data Management

Powerful, real-time query and data management features

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Key Features

  • Point of entry checks
  • Real-time query creation & resolution
  • Remote data management
  • Integrated background edit checks flag inconsistent data
  • Real-time workflow between coordinator and data management
  • Multiple data imports/exports

Safety Tracking and Reporting

Greater Accuracy, Accountability and Awareness

Fully integrated AE/SAE tracking and reporting for single or multi-country studies/regulatory bodies, including email notifications and optional MedWatch/Fax cover pages.

SAFETYExpanded module offers drug safety adverse event management process for multiple regulatory bodies/country AE/SAE submissions.

Includes AE/SAE Tracking plus ability to add Case Narratives, generate reports, track submissions, get notifications. 

Key Features

  • Fully customizable to sponsor specifications
  • AE/SAE/SADE report forms
  • Repeatable follow-up form
  • Queries between site and drug safety group
  • MedWatch/government regulatory forms
  • Add Case Narratives, generate reports, track submissions
  • Integrated con meds means no double data entry
  • No manual data tracking, no reconciliation

Payment Tracking

Easy to use, fully integrated management of your study budgets and payments

Fusion’s Payment Tracking Module provides fully integrated payment management and budgeting, eliminating complicated manual reconcilations between your clinical technology and external payment tracking solutions such as Excel.

All study related information is pulled directly from the eClinical suite in real-time, allowing for quick and easy review, and automation of many tasks and reminders.

Key Features

  • Overall tracking of payment history
  • Pending payments, automatic triggers and reminders
  • Management of site, vendor, start-up and miscellaneous payments
  • Quickly build site budgets and review cost structures
  • Payment Templates can be applied to one or more sites and are easily copied and customized per site or across a selection of sites
  • Immediate access to all payment related information with customizable reporting and automated email notifications

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Randomization

Simple to complex randomization, fully integrated and linked to inventory

Web-based or phone based study randomization.

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Key Features

  • Randomization and drug inventory linked for full awareness of supply process
  • Randomization Status and other reports
  • Support for multiple randomization blocks/schemes
  • Stratification variables globally or by site
  • Emergency unblinding
  • Adaptive support
  • Eligibility checks

Monitor Trip Reporting

Simplify Monitoring and Tracking, Review of Monitoring Reports

Key Reports

  • Monitor Aging Report
  • Monitoring Visit Metrics Report
  • Monitoring Visit Status Report
  • Monitor Progress Report

Book visits, enter data or upload report. Update reports and digitally sign-off on completed reports.

Allows for Sponsor or CRM review of monitoring reports, approval or update requests, and digital signature of completed reports.

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Drug/Device Supply Tracking

Centralized drug or device supply chain management and reporting

Provides global awareness of inventory activities, balances, and issues as well as notifications of key events including inventory levels, shipments, requests and pending activities.

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Key Features

  • Depot Inventory
  • Requests/Shipments and Receipts
  • Inventory Management/Tracking
  • Drug/Device Quarantine/Return

Configurable Report Builder

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Drag and Drop to Build Custom Reports

Axiom’s dynamic Report Builder allows access to all study data and metadata to build your own reports. Choose from tables, listings, or graphs. Access your entire eCRF with drag and drop tools to create desired reports, no programming required. Save custom reports to re-run as required, and all custom reports can be re-used in follow up studies if desired.

Key Features

  • Access to entire eCRF to build custom reports
  • No programming required
  • Immediately view reports and export data to excel or PDF
  • Save customized reports to re-run at a later date

 

Adjudication

Manage adjudication activities within Fusion without any manual processes.

Simplify the process and decrease both time and effort.

Key Features

  • Clinical documents are shared electronically, no paper required
  • After review, assessments are provided back electronically
  • Responses are compared within Fusion, and depending on the requirements a third reviewer is engaged to assess as required
  • Increases speed of adjudication and moves study forward quicker

ECG/Imaging Upload

image_uploadAutomatic import of external study data including ECG or imaging files.

Key Features

  • Automatic import of external study data
  • View image files from within Fusion
  • No reconciliation with external vendors

Deviation Tracking

Allows for centralized tracking, management and reporting of all site/study deviations.  Eliminates manual reconciling of deviations externally against the data in the EDC system.

Key Features

  • Tracks both eCRF related and site/study related deviations in real-time
  • Standard and customizable deviation reports, including graphing top deviations
  • Eliminates reconciliation and related manual tasks

Waiver Tracking

Allow for review, approval and tracking of all waivers for study subjects.

Integrated into Fusion and available at no-charge. 

Key Features

  • Review and approve waivers via eSignatures
  • Record all waivers within Fusion
  • no manual tracking – integrated waiver reporting

ePRO/Patient Portal

Record patient diaries via an easy-to-use, customized portal.  Access via the web or any mobile device or tablet.

Completely integrated with study database.  Secure, de-identified patient linked information. patient-portal

Key Features

  • Automated reporting keeps track of the level of patient data completion/outstanding information.
  • CRF is completely configurable
  • Pages save automatically with any navigation of the system. No need to press save.
  • Communications can be sent to a sub-set of the subject population via the portal
  • Reminders and other notifications advise patients of when to complete diaries/what information is outstanding
  • Emails to patients are customizable, and portal and emails can include graphics

Data Export Module

On-demand access to your entire study.

Access your clinical data on-demand via a web-based portal. User selectable file export formats. Choose to export all study data, or a sub-set of data such as clean, dirty, etc.

Key Features

  • On-demand data exports
  • ASCII – Excel – Access – SAS Transportable
  • Customized formats (based upon client requests)