InForm CRF Submit

As part of the clinical study and new drug or device approval process, at the close of a study and when the decision is made to seek final approval of a biologic, drug or device, sponsors must submit a Biologic License Application (BLA), a New Drug Application (NDA) or a Pre-Market Approval (PMA) to appropriate regulatory agencies. Additionally, sponsors are obligated to provide participating study sites with a complete archive of all the data collected during the trial.

The InForm CRF Submit module streamlines the preparation process for archives and eSubmissions by producing Adobe® Portable Document Format (PDF) editions of the InForm electronic case report forms (eCRFs). PDFs include a hyperlinked table of contents and bookmarks that are designed to fully comply with the FDA guidance based on the International Conference on Harmonization (ICH) Electronic Common Technical Document (eCTD) standards.

High-Impact Features:

  • Generates PDF editions of case record books, with full audit trails
  • Automatically builds hyperlinked bookmarks, tables of contents, and search indices following FDA eCTD guidance
  • Produces blank forms for all study versions, CRF help files, and protocol guides
  • Exports all study data or a subset based on site(s), patient(s), or treatment
    group(s)
  • Creates PDFs in U.S. letter and/or A4 page formats
  • Can be deployed as a Phase Forward ASP-hosted solution or implemented internally by InForm enterprise adoption customers
  • Web-based interface provides ease-of-use and remote access
  • Features distributable, multi-threaded architecture for optimized throughput