Bioresearch Monitoring (BIMO) Frequently Asked Questions Forum
Project Description |
|---|
This project develops a Bioresearch Monitoring (BIMO) Frequently Asked Questions (FAQ) Forum on the PHUSE Advance Hub, aligned with the established SEND FAQ format. The forum consolidates questions from the pharma and CRO community, including inputs from public reviews, presentations, and PHUSE BIMO team members. The FDA’s BIMO Technical Conformance Guide (2017; updated 2020) defines requirements for electronic submissions supporting BIMO inspections, including clinical study-level information, subject-level data listings by site, and the clinical site dataset (clinsite.xpt). BIMO is a critical component of NDA, BLA and supplemental submissions, with organisations developing approaches based on this guidance. Work on the PHUSE Bioresearch Monitoring Data Reviewer’s Guide (BDRG) highlights ongoing industry questions. Many are captured in the BDRG Communication Tracker, alongside broader queries arising from implementation and review activities. A centralised FAQ forum provides consistent, coordinated responses to support both sponsors and regulators. |
Project Leads | |
|---|---|
Sopan Kaith, Alexion | |
Alex Pearce, PHUSE Project Coordinator |
Click above for the latest project status. |