Mid-Study Transfer of a Phase III MS MRI

Challenge

A Phase III multiple sclerosis program had fallen into difficulty under its previous core lab. Lesion assessments demonstrated weak inter-reader agreement, calling into question the reliability of the gadolinium-enhancing and new T2 lesion counts on which the trial's endpoints depended. Compounding the problem, more than 1,800 MRI examinations awaited central review, and the backlog continued to grow. The sponsor needed to transfer the program mid-study while preserving interpretive continuity with the assessments already completed.

Our Solution

Intrinsic Imaging transferred the complete image archive onto our validated platform with full data-integrity verification, then consolidated lesion-counting conventions into a single harmonized charter. Before central review resumed, our neuroradiologists underwent focused training on the prior reading conventions, ensuring that post-transfer assessments remained consistent with the existing dataset rather than introducing a methodological discontinuity. The accumulated backlog was then worked through systematically under the unified charter.

Results

• Read backlog cleared within 60 days
• Lesion-count agreement exceeded 95% in repeat-read samples
• No change to the primary endpoint timeline