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Portfolio and program adaptive design
We believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.
Our Statistical experts work on projects such as:
Merck pioneered adaptive dose-finding methods but needed to validate their designs. Cytel provided custom software that allowed them to simulate and compare various adaptive design scenarios.
With the use of a promising zone approach Cytel ‘de-risked’ the study and improved transparency. The client obtained external investment with a flexible, novel financing structure that was linked to interim results in a staged approach.
Client received questions from regulatory agency including points on potential biomarker discrepancies - responses required in 30 days.