Perspective
Navigating China IIT Importation Without Losing the Speed Advantage
China IITs Are Unique and Operationally Challenging Across the Clinical Supply Chain China IITs can offer advanced therapy sponsors a…
Clinical Quality by Design (cQbD): The Blueprint to GCP Inspection Readiness
Two findings dominate FDA Bioresearch Monitoring (BIMO) GCP inspection metrics year after year: clinical protocol noncompliance and inadequate monitoring. Despite…
Perspective
The Quarter Horse: Issue 22
Issue 22 of the official Dark Horse Consulting Group newsletter.
Don’t Put the CAR-T Before the Horse: Nonclinical and CMC Strategies for Development of In Vivo CAR-T & Beyond
In vivo CAR-T and related in vivo cell therapies represent one of the most promising frontiers in advanced therapy development,…
Perspective
The Quarter Horse: Issue 21
Issue 21 of the official Dark Horse Consulting Group newsletter.
Clinical Supply-as-a-Service Enables Mid-Study IRT Adjustments with No Interruption
Converge Consulting provided comprehensive Clinical Supply-as-a-Service (CSaaS) support for a precision medicine developer’s Phase I/II clinical trial, serving as the…
How Early Protocol Design Shapes Supply Strategy and RTSM Readiness
Early protocol design decisions carry significant operational consequences for clinical supply strategy and randomization and trial supply management (RTSM) performance.…
Perspective
The Quarter Horse: Issue 20
Issue 20 of the official newsletter of the Dark Horse Consulting Group announced the acquisition of Converge Consulting.
Beyond ERP: How Apellis Scaled Global Planning
Empowering agile analytics-driven supply planning alongside SAP Apellis Pharmaceuticals was at a pivotal stage of growth, transitioning from managing a…
Perspective
Quarantines, Complaints, Temperature Excursions & Other Debacles: Mitigating the Impact of Clinical Supply Disruption
While the best way to avoid clinical supply disruption is through careful planning and setting up a robust supply chain,…
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Converge Consulting exclusively serves the Life Sciences industry with strategy, operations, and execution expertise. We are based in the Boston/Cambridge area, one of the most active hubs for Life Sciences best practices in the world.