vtEAP

Early / Expanded Access Program (EAP) Support

Arranging for Early or Expanded Access Programs for investigational medicinal products is a key responsibility for medical functions within global pharmaceutical companies. In providing such access, compliance is required with a number of applicable country- and region-specific guidelines (e.g., the recent Cures Act), together with internal procedural approaches.

Full EAP workflow coverage

Visiontracker EAP supports, documents, and streamlines pharmaceutical company commitments to provide patients with access to investigational medical product use outside of a clinical trial, covering the full process of EAP request submission, review, agreement, supply/re-supply, and reporting aspects. The software includes an externally accessible web portal to post current policy and facilitates request applications from treating physicians. Visiontracker EAP enables full compliance with FDA and corresponding international guidelines on Expanded Access, as well as the ability to support company-specific operating procedures.

Business impacting elements

Compliant

  • Efficient and compliant management of EAP Programs
  • Out-of-the-box EAP-focused configuration, based on supporting industry best practice

External interface

  • Professional and easy-to-use external healthcare practitioner-facing web portal to manage requests
  • Public posting of company EAP policy on web portal

Process support

  • Rule- and role-based workflow to drive timely reviews and responses
  • Robust reporting capability
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