VISION Overview – The # 1 Best Kept Secret in Clinical Research

Welcome to VISION. Leverage the most versatile EDC tool in the industry to make your next clinical trial experience smooth and efficient. Our EDC includes both CTMS and CDMS features that consolidate your work flow and accelerate study submissions.

The VISION™ EDC capabilities are the most powerful and flexible in the industry. Our unique architecture allows you to stand up a study record time, while incorporating sophisticated functionality such as randomization. The VISION™ platform is fully validated and is 21 CFR Part 11, Annex 11 and HIPAA compliant – allowing you full confidence in your submissions.

Increase Efficiency and Accuracy with VISION’s EDC Functionality

Subject & Site Level Forms

  • Sites have data too! We offer comprehensive data collection and reporting for subjects, sites and users.
  • Standard data entry elements (e.g., text fields, radios, drop-downs, check boxes date and time, etc.).
  • Plus, custom data entry elements such as VAS scales and interactive charts
  • Enter data in tabular fashion with an unlimited number of rows. Great for daily logs!

Auto Data Cleaning

  • Powerful edit checks reduce the workload on monitors and data managers and can replace up to 80% of data cleaning efforts.
  • Ensure all required data is collected on each eCRF.
  • Ensure data entered meets range and format requirements.
  • Comprehensive suite of calculations streamlines operations.
  • Automate dosing calculations.
  • Calculate ages and anticipated study visit dates.

Monitoring and Study Close-out Tools

  • Intuitive indicators enable monitors to quickly identify the state of study eCRFs and focus on those that need attention.
  • Forms with errors, not yet finalized or with outstanding queries
  • Granular locking capability for individual forms, subjects, sites or an entire study facilitates study close out.
  • Integrated study archive functionality

 

Why use two systems to manage your clinical trial? VISION™’s integrated CTMS functionality uses information already in the EDC to help you streamline operational flows and reduce errors.

Clinical Trial Management System

Inventory Management

  • Site level inventory management and dispensing tracking interfaces with subject level dispensing.
  • Automatic reordering ensures IVP/CP is always available when neeeded.
  • Automatic notifications keep monitors and study staff abreast of product availabality.
  • Shipping management helps control chain of custody.

Invoicing

  • Set up the fee schedule at the beginning of the study for the study as a whole or by site. Multiple currencies are supported!
  • Automatically post fees to invoices as sites complete activities or as monitors ensure activities are completed.
  • Reduces the need to confirm the fees should be paid because they only post after the activities have been completed.
  • Keep sites happier by making payments faster.

Document Management

  • Set up required document lists at multiple levels (subject, site, personnel, study)
  • Automatic notification of new document availability and of upcoming expirations.
  • Maintains access to document versioning and tracks downloads.

The cardinal rule of Clinical Data Management is “know thy data”. VISION™’s CDMS tools allow Data Managers and Monitors to quickly filter and intuitively view aggregated information using a variety of criteria. Using these tools throughout the course of a study aids endpoint analysis and speeds study close-out efforts.

Clinical Data Management System

Filter and Search Data

  • Create and save unlimited data filters and search criteria.
  • Quickly focus in on th endpoints or populations.

Export

  • Download and Access your data anytime, anywhere.
  • Filters allow export of as much or as little data as needed.
  • Export all instances of a single form.
  • Export data for one subject/site.
  • Configure and save export criteria.
  • Share export criteria expedites study closeout.

Reports, Statistics and Graphs

  • Integrated with filters and searches.
  • Reports can be configured to aggregate data from multiple forms.
  • Professional statistics and graphs are available to assist in data comprehension.
  • Create, save and share an unlimited number of custom reports, statistics and graphs.
  • Download in PDF or Excel-ready format.
    • Can be incorporated in final study reports.

Customizable Dashboard

Allows Display of multiple reports, graphs or summaries on a single web page.

  • Each can use a custom filter.
  • Provides access to study notifications.
  • Helps personnel quickly see important information.

Each user can customize their dashboard with information pertinent to their needs.

The Prelude Dynamics EDC system is very user-friendly, versatile, and quite intuitive from both the Sponsor/CRO’s AND the Clinical Site’s perspective. On top of that, the team at Prelude is forward-thinking and very supportive, providing great demos and training, thinking creatively about practical solutions for small and larger studies alike, and answering all of our questions very promptly and clearly. Jessica B.

CEO

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