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Trial Planning

Pro-actively planning your clinical trial

 

  • Itemized project plans
  • Comprehensive specifications
  • Electronic repository for project documents

Overview

Specifications:

Comprehensive specifications are created with minimal build input requirements from the Sponsor.  The provision of annotated CRFs and required edit checks will be formatted into an extensive document used by PharmaVigilant engineers and testers.  In addition to the data variables present on an annotated CRF, this specification defines all of the EDC system configurations specific to each study.   By thoroughly specifying all aspects of the EDC system, PharmaVigilant provides each Sponsor with the foresight of how their trial will look and function electronically prior to their opportunity for user acceptance testing.


Project Plans:

PharmaVigilant project managers will create a project plan itemizing all contracted deliverables and timelines.  This document identifies all resources associated with each task and the timeframes required for task completion.  By maintaining and distributing this project plan as updates are received or milestones reached, PharmaVigilant takes a pro-active approach to managing all deliverables and reducing the risk of project creep.


I-Vault PM:

I-Vault PM is an internal application created for all new trials.  PharmaVigilant will create an electronic repository for all project documentation.  Files such as specifications, validation documents, Help Desk logs, deployment plans, and sign-off sheets are all stored within I-Vault PM.  Access will be given to the Sponsor as to provide visibility to all project documentation.

 

Contact Us for a Trial Planning Consultation

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+1-508-898-0018 
+1-866-497-4361