Downloadable case studies, SOPs, project plans, and guidance
We've ungated our content! Just click to download any of these Ready Room case studues and other helpful content.
What's new with the BIMO Compliance Program Manual for Sponsors and CROs?
In September 2021, the US Food and Drug Administration (FDA) published the first update to its Bioresearch Monitoring Compliance Program Manual for Sponsors and Contract Research Organizations since 2017. Other than the switch from serif to sans serif, what’s new?
Ready Room GCP Inspection Readiness Project Plan Template
Download our free Microsoft Project template with activities and a schedule that can be modified to fit your team’s needs.
Standard Operating Procedure Hosting Regulatory Authority Inspections
A Standard Operating Procedure for hosting a regulatory authority inspection should define the process at a high level while giving the team flexibility to adjust for different scopes and scenarios.
Blueprint Medicines is Ready
Discover how a biotechnology company in Cambridge, MA used Ready Room to optimize cross-functional collaboration to ensure rapid and accurate responses to inquiries from regulatory authorities.
GCP Inspection Readiness Timetable and Prep Guide
A clinical program is inspection-ready when the inspection team can deliver responses and documentation that tell a quality story about its execution to the FDA, EMA, or other regulatory body. Prepare with this practical step-by-step guide to GCP inspection readiness.