Take Control of Your Study Build.

With Prelude Dynamics’ newest eClinical EDC solution, a do-it-yourself tool that puts the study build in your hands. Composer a powerful part of our VISION™ eClinical Suite.

Much like our flagship product, VISION, you and your team can access Composer via a web browser. Once signed in, you have the ability to build your electronic CRFs with drag and drop modules and plug and play edit checks, and assemble them into a visit schedule.

It is a web-based clinical trial management system that supports Electronic Data Capture, Data Management, and Project Management in a manner that is compliant with both 21 CFR 11 and Annex 11. Composer™ is a WYSIWYG (what you see is what you get) “do it yourself” study tool which provides mechanisms for developing a study by defining forms and data entry fields along with various edit checks and calculations. Once a study is created using Composer™, that study can then be run within Composer™ which can be accessed from anywhere an internet connection is available. With Composer™, navigating through forms and entering data works the same as it does in VISION™. Please refer to the VISION™ user’s manual for information on entering data into the study.

COMPOSER WORKFLOW

VISION Composer Workflow

Integrated eCRF Form Library

Composer comes with a library of basic preest forms that can easily be included into any study. These preset forms are standard eCRFs which are frequently used in clinical trials and studies. These preset eCRFs will significantly decrease the time required to build a GCP-compliant study.

Standard forms are integrated into your clinical study by default. They are used as is and cannot be modified or removed from the study. These include:

Site level forms
  • Demographics
  • Deviations
  • Site Visit Log
  • Notes to File
  • Archived Subjects
Subject level forms
  • Demographics
  • Protocol Deviations
  • Queries
  • Notes/Errors

These integrated eCRFs are also automatically included in every study and, like the Standard Forms, cannot be modified.1 These Optional Forms can, however, be eliminated from a study should you, the user, so choose.

Subject level forms
  • 1Eligibilty (can be modified, see Template Forms)
  • Adverse Events
  • Concomitant Medications
  • Study Completion
  • Early Withdrawal

These integrated eCRFs are template forms that can be tailored by you. These forms are not automatically included in a study but are easily added once you've customized them to meet your needs.2

Site level forms
  • Site Survey
Subject level forms
  • 2Eligibilty (Automatically included but can be removed.)
  • Physical Exam
  • Subject Survey

Composer supports a robust set of features that are essential for the development of EDC-based clinical trials. Composer comes preloaded with Real-time Randomization and Adverse Event & Con Med tracking. Note to File, Note to Field, Queries and Deviations are also included, as are annotated CRFs & User Activity Log. With everything needed for a small study, Composer puts control in your hands.
What Features can you find in Composer?
Edit checks Note to File Randomization
Calculations Note to Field Blinding
Custom Forms Protocol Deviations Search/Filter Subjects
Forms selected from a library Queries Ad-hoc Reports
Cross-form edit checks Adverse Event Tracking Database Export
Pushing data between
Subject ⇔ Site
Concomitant Medication Tracking Database Archive
Auto-complete Fields Reason for Change Tracking Annotated CRFs
Full Audit Trail User Activity Log ...

Learn more about Composer, Schedule a Demo Today!