FAQ

What are the cost drivers for VISION™ EDC?

VISION™ is a Clinical Trial Management System consisting of multiple modules which can be added as needed, such as Clinical Trials Management System, Clinical Data Management System, e-PRO, and more.

The system can be customized according to your protocol and process.

In establishing a fair estimate Prelude would account for the following:

  • Project Setup
  • Number of unique CRFs with logic, branching, and calculations
  • Complexity of project
  • Optional modules
  • Number of Sites for Archive
  • Study Duration
  • Monthly Recurring Fee for term of study
  • Study Close-out / Archive
  • Number of Sites
  • Archive type XML is standard, HTML is optional
  • Electronic download is standard, CD/DVDs are optional

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Can we test drive or demo VISION™?

Yes!

We offer a free live demo of VISION™ either in person or via online meeting or webinar. By filling out the form on our Demo Signup Page we will contact you to schedule a demo at your earliest convenience.

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Can I build my own eCRFs and/or build my own studies?

Yes, Prelude offers VISION™ Composer which is a robust, fully-functional do-it-yourself EDC solution for smaller studies at lower price points.

For our Premium and Pre-Built solutions, currently, Prelude builds the eCRFs using examples of paper CRFs (Case Report Forms) provided by the sponsor as well as referencing the study protocol.

This helps to standardize the eCRFs and leverages Prelude’s experience across hundreds of studies. Future projects which utilize eCRFs are less expensive due to reuse.

eCRFs and paper CRFs are not the same. eCRFs have logic and edit checks built-in to run behind the scenes. This allows the entered value to be cross-checked against normal ranges, or selected from a drop-down database, etc.

Prelude works to streamline the data “workflow” to simplify process of entering data and minimize need to enter the same data across multiple forms. This logic and cross-form edits help to maintain a clean database throughout the entire duration of the study, which builds confidence in the outcome and results.

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Can I reuse eCRFs from a library?

Yes, Prelude works closely with the Sponsor to drive standardization of eCRFs.

Prelude takes the next step by incorporating Sponsor-specific defined data terminology or naming conventions which help support biostats and data analysis.

Ask us about a free demo of Preude’s VISION™ Pre-Built solution which works to templatize your eCRFs for current and future studies.

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How often can I access study data?

Anytime! The server is live 24 hours per day, 7 days per week, 365 days per year. Access is controlled by permission-based, secure user IDs and passwords. Based on your User role, you may only have access to select forms and functionality.

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Is offline data collection possible?

Yes.

Prelude has an app (IOS, Android, and webstart) called Digital Paper that collects off-line and uploads later when connected to the internet. (However, it is rare these days to be in an area where internet is not readily available, even on trains and via satellite.)

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Is VISION™ in compliance with FDA 21 CFR Part 11?

Yes, VISION™ meets the current guidelines for Part 11 for:

  • Electronic signatures
  • Proper Audit tracking
  • Life Cycle Process

Generally, Prelude only knows which regulatory agency the data will be submitted to based on information in the protocol and/or discussions with the Sponsor. We rarely know the outcome of the submission unless it is shared by the Sponsor Company. We are aware that VISION™ has been used for:

  • GLP / GCP submissions
  • USDA submissions
  • EPA submissions
  • EMA submissions

Prelude suggests that your QA Group get involved and provide internal guidance.

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