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Solutions > Site-based ePRO

SitePRO® - Site-based ePRO Capture Tool

Increase efficiencies in the collection of site-based patient reported outcomes (PRO) data in clinical trials

ePRO SitePRO NurseThe SitePRO Tablet, invivodata’s second-generation large-screen solution, automates paper-based site assessments and enables clinical trial sponsors to manage both site and patient-based assessment data in a single source.  The SitePRO Tablet utilizes the same, proven invivodata SitePRO software used successfully in site-based ePRO studies since 2004 and is the industry’s only site-based ePRO solution to have collected primary efficacy data in support of a successful New Drug Application (NDA).

The full-sized 12-inch display screen offers significant advantages over other currently available site-based ePRO solutions:

  • Accurately captures lengthy quality-of-life and other in-clinic-based assessments in either portrait or landscape mode.
  • Allows for more accurate transition from paper to electronic assessments and handles large scales without compromise.
  • The migration of a paper scale to a SitePRO Tablet in many cases will not require a modification to the core assessment layout, reducing or eliminating validation costs.

In addition, the SitePRO Tablet provides multiple data transfer options to meet site and sponsor needs and provides complete ePRO trial data visibility through invivodata’s EPX ePRO Management System.

About invivodata's SitePRO® Solutions
invivodata's in-clinic solution, SitePRO, combines the best of clinical science with mobile device and Web technology to increase efficiencies in the collection of site-based patient reported outcome (PRO) data in clinical trials.

Clinical Trial Role

Benefit

Sponsors
  • Improves efficiency by collecting clean, in-range, legible PRO data that can be automatically scored
  • Avoids clinician-biased data by ensuring consistent administration of site assessments
  • Avoids common missing data problems with paper-based PROs
  • Reduces study timelines by eliminating the need to transcribe hand-entered PRO data

Sites
  • Saves time and increases efficiency
  • Reduces paper administration burden
  • Reduces time it take to administer site assessments
  • Supports diverse patient demographics and accessibility requirements, thereby increasing the pool of patients available for enrollment

Patients
  • Decreases time to complete assessments through a user-friendly interface
  • Provides accessibility features based on patient population including: enlarged fonts, oversized stylus and increased alarm volume
  • Offers an easy-to-use, proven patient interface which eliminates patient confusion

SitePRO Highlights

 

  • Easy-to-navigate patient interface
  • Ability to capture more complex text-based questions including dynamic sampling (changes based on patient's entry)
  • Accommodates numerous question types
    • Visual analog scales (horizontal & vertical
    • Ordinal scales
    • Likert scales
    • Pushbuttons (for exclusive answers)
    • Checkboxes (for multiple answers)
    • Free text entry
    • Controls for numeric entry
    • Time and date entry (duration, 24hr, AM/PM)
    • Graphical figures (e.g., Body Diagram)
    • Wait screens (while patient completes an action)
  • Multi-lingual capable
  • Configurable data recording and format
  • Within-question edit and range checks
  • Question-to-question edit checks for logical consistency of answers
  • Tracks and adjusts to multiple phases of trial
  • Eligibility calculations for randomization decisions
  • Complete and detailed audit trail
  • Multiple data transfer technology options
  • Available on multiple hardware platforms

Hardware Device

Device Specifications

SitePRO Tablet

SitePRO Tablet

Size of unit

  • Weight: 3.3 lbs.
  • 11.65"W x 9.64"H x 0.74"D

Display

  • High-resolution, 12.1" color display (1024x768)
  • Rotates to landscape or portrait

Operating system: Microsoft® Windows® XP

Power options: AC Adapter or rechargeable lithium-ion battery

Functionality

  • Allows for lengthier assessment text, similar to U.S. letter-sized paper
  • Ethernet, wired and wireless data transfer options

SitePRO TX

SitePRO TX

Size of unit

  • Weight: 5.25 oz.
  • 3.08"W x 4.76"H x 0.61"D

Display

  • High-resolution, color display (320x480)
  • Rotates to landscape or portrait

Operating system: PalmOS®

Power options: Rechargeable lithium-ion battery

Functionality

  • Allows for lengthier assessment text on a compact device
  • Wired and wireless data transfer options

SitePRO EX

SitePRO_EX

Size of unit

  • Weight: 4.7 oz.
  • 4.5"W x 3.1"H x 0.59"D

Display: Color display - 320x320

Operating system: PalmOS®

Power options: Rechargeable lithium-ion battery

Functionality

  • Ideal for use with shorter assessment text
  • Wired and wireless data transfer options

Interested in seeing your in-clinic assessments, such as the WOMAC, IBDQ, SF-36, SF-12, and WPAI on the SitePRO Tablet?

 

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