Checking in on (RBQM) Risk Based Quality Management One Year After ICH E6(R3)
Risk Based Quality Management One Year After ICH E6(R3) The industry is navigating a complex transition, balancing the adoption of innovative technology, maintaining study timelines, ensuring patient safety, and safeguarding data integrity. RBQM is a vital in helping with the adoption of these new technologies. The risk-based approach is foundational to creating a data-driven culture […]
Scaling Manufacturing Capabilities to Support Phase 1 and 2 Clinical Operations for a Clinical-Stage Biotechnology Company
Business Problem & Situation A clinical-stage biotechnology company specializing in targeted gene therapies for central nervous system disorders faced pressure to scale up its manufacturing operations quickly in preparation for Phase 1 and 2 clinical trials. Their internal recruitment strategy wasn’t agile enough to accommodate the ramp up needed to support their time-sensitive clinical programs. […]