eSubmission Readiness Services

Iris’ primary service is supporting biotech and pharmaceutical companies in their CDISC data submissions for licensing applications. Our clients rely on Iris to provide them with confidence that their data packages are review ready and we do this through our technical and regulatory know-how.

Be Review Ready

A typical New Drug Application (NDA) and Biologics License Application (BLA) project begins with strategic consultation and a careful inventory of existing study data and supporting documentation.  Most submissions require some remediation of data or metadata prior to an NDA or BLA filing.  Our process for evaluating CDISC data packages utilizes our proprietary checklist and electronic validation reports.

  • Inventory and gap analysis of clinical study data and documents for health authority filings like NDAs and BLAs.
  • Evaluate data packages for eSubmission readiness, including compliance to current health authority guidance (including CDISC data, defines, reviewer’s guides, and case report forms annotated for SDTM.
  • Review electronic validation reports for CDISC and health authority validation rules.
  • Write or edit the clinical study data reviewer’s guide (csdrg.pdf) and the analysis data reviewer’s guide (adrg.pdf) for reviewability, transparency, and reduction of information requests.
  • CDISC implementation consultation and review of data mapping strategies.
  • Write or review the Study Data Standardization Plan.
  • Aid in the preparation of data submissions by drafting study data standard waiver requests, prepare example data submissions for FDA, and authoring questions for briefing books concerning data strategies.
  • Review health authority information requests concerning data submission packages and write responses.