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VISION

VISION

EDC, CTMS, CDMS, ePRO

one platform. four solutions.

ELECTRONIC DATA CAPTURE

The VISION EDC capabilities are the most powerful and flexible in the industry. Our unique architecture allows you to stand up a study in record time, while incorporating sophisticated functionality such as randomization.

CLINICAL TRIAL MANAGEMENT SYSTEM

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 DATA MANAGEMENT SYSTEM

VISION’s CDMS tools allow Data Managers and Monitors to quickly filter and intuitively view aggregated information using a variety of criteria. Sophisticated graphs and statistics facilitate endpoint analysis.

ePRO

Easily collect Patient Reported Outcomes in the EDC database using our ePRO app for mobile devices. The data collected is fully attributable (audit trail) and can be included in reports and statistics.

BUILD IT YOURSELF, or

WE’LL BUILD IT FOR YOU

VISION™ SUPPORTS THE ENTIRE CLINICAL TRIAL ECOSYSTEM.

Subject

  • Mobile ePRO app allows subjects to intuitively enter scales, complete questionnaires and view/upload videos.
  • Data is captured directly in the EDC with no transcription required!
  • Facilitates remote study participation.

Monitor

  • Data is entered directly into the EDC (eSOURCE) – allows real-time monitoring
  • Remote monitoring is fully supported
  • Focused custom reports facilitate risk-based monitoring

Site

  • Intuitive EDC functionality incentivizes site enrollment
  • Logical user interface promotes protocol compliance
  • Integrated invoicing keeps sites motivated

Regulatory

  • 21 CFR Part 11, Annex 11, GDPR and HIPPA compliant
  • Fully validated platform that has been used for thousands of submissions to regulatory authorities
  • XML, HTML and PDF archives

Data Manager

  • Most powerful suite of cross form calculations and error checks in the industry
  • Automated dictionary coding
  • Unique “As Built” Study Requirements Document

Project Manager

  • Easily detect trends and issues with in-platform summaries, filters, custom reports
  • Integrated site invoicing streamlines admin and aids in site retention
  • EDC/CTMS/CDMS functionality keeps data in one place

Biostatistician

  • Sophisticated graphs and statistics for end-point analysis during the study
  • XML Export format compatible with regulatory requirements
  • Flexible export function aids import into SAS

Sponsor

  • Single platform streamlines operations
  • Tools to speed study submission
  • Quick implementation of mid-study updates

Subject

  • Mobile ePRO app allows subjects to intuitively enter scales, complete questionnaires and view/upload videos.
  • Data is captured directly in the EDC with no transcription required!
  • Facilitates remote study participation.

Monitor

  • Data is entered directly into the EDC (eSOURCE) – allows real-time monitoring
  • Remote monitoring is fully supported
  • Focused custom reports facilitate risk-based monitoring

Site

  • Intuitive EDC functionality incentivizes site enrollment
  • Logical user interface promotes protocol compliance
  • Integrated invoicing keeps sites motivated

Regulatory

  • 21 CFR Part 11, Annex 11, GDPR and HIPPA compliant
  • Fully validated platform that has been used for thousands of submissions to regulatory authorities
  • XML, HTML and PDF archives

Data Manager

  • Most powerful suite of cross form calculations and error checks in the industry
  • Automated dictionary coding
  • Unique “As Built” Study Requirements Document

Project Manager

  • Easily detect trends and issues with in-platform summaries, filters, custom reports
  • Integrated site invoicing streamlines admin and aids in site retention
  • EDC/CTMS/CDMS functionality keeps data in one place

Biostatistician

  • Sophisticated graphs and statistics for end-point analysis during the study
  • XML Export format compatible with regulatory requirements
  • Flexible export function aids import into SAS

Sponsor

  • Single platform streamlines operations
  • Tools to speed study submission
  • Quick implementation of mid-study updates

OUR TEAM OF CERTIFIED DATA MANAGERS

When you ask us to build your study for you, we will put our team of CCDMs to work. These professionals have years of experience developing studies using either well-defined protocols or (in academic environments) no protocol at all! 

 Our Project Managers are trained in GxP and know which study forms must be present to ensure compliance. They also are well-versed in using VISION™ to implement even the most complex eCRFs. 

Prelude’s reach spans the globe.

Successful FDA, CVM, USDA & EPA Submissions

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