FDA Advisory Committee and EMA Oral explanation Support

Innovative Science Solutions (ISS) can help ensure a timely approval by providing an integrated approach to managing all aspects of an FDA Advisory Committee/EMA oral explanation meeting for your product. We provide a one-stop solution for all the mission critical elements and deliver unmatched services.

ISS is involved in more FDA Advisory Committee meetings per year than even the largest pharmaceutical companies. ISS has also extensive Oral explanation expertise.

ISS provides an integrated approach to manage all aspects of such meetings:

  • Scientific data review
  • Regulatory strategy
  • Key messages definition, testing, and implementation
  • Key deliverables development and creation support (e.g., core presentation, briefing book, backup slides, etc.)
  • Identification of experts (speakers, mock panelists)
  • Speaker training
  • Open Public Session
  • Meeting logistics support


ISS’ proprietary, cloud-based platform, DataTrove®, is designed specifically for integrating strategy and tactical implementation for advisory committee preparation.

This secure system is easy to use and integrates all of our advisory committee preparation services including project and slide management. DataTrove® provides a streamlined workflow facilitating and encouraging team collaboration.


Managing the many moving pieces of Advisory Committee preparation is a daunting task – DataTrove is the online solution to streamline workflow, manage team collaboration, and integrate the ISS suite of Advisory Committee services.

Centralized and Comprehensive
  • All information in one place; a central location for document creation, revision, review, and publishing
  • Edit collaboratively with team members and easily alert others to new changes and drafts
Project Management Orientated
  • Full suite of project management tools to track calendars and timelines
  • System alerts remind team members of assigned tasks and due dates
Integrated and Immersive
  • Manage slide content from development, creation, drafting, revision through slide retrieval at the live meeting
  • A secure worksite, continuously monitored to be up to date with the latest security requirements
  • Password protected and different levels of access across users
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