Resources
Downloadable case studies, SOPs, project plans, and guidance
We've ungated our content! Just click to download any of these Ready Room case studies and other helpful content.
Presentation
SQA 2024: How to Talk to Your Clinical Study Teams about Data Integrity
Five key concepts to promote understanding of record integrity with your study teams.
Case Study
Agios Pharmaceuticals is Ready
Over two weeks, the team successfully processed hundreds of requests and documents.
Guidance
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?
Project Plan
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.
SOP
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.
Case Study
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.
Guidance
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.
Guidance
Inspection Readiness White Paper
For more ideas about how to prepare for a GCP inspection, download our white paper on Getting Ready for a GCP Inspection.
Guidance
Map Ready Room Features to Inspection Readiness and Management
How to use Ready Room to prepare for, manage and follow up a GXP inspection.
System Architecture
Security Statement
Detailed information regarding Ready Room security, including infrastructure, storage, authentication, and system integration. To be shared with your IT department. Updated September 16, 2024.
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