Fast-Track Rare Disease Oncology Trial

Challenge

Registration trials in rare diseases operate under unforgiving constraints. With fewer than three patients per site spread across 40 sites in 14 countries, every imaging timepoint carried outsized weight, and any delay in central review directly threatened enrollment momentum. The sponsor's Priority Review designation compressed timelines further, requiring a core lab capable of rapid startup and exceptionally responsive query handling without compromising the rigor of the imaging assessments.

Our Solution

Intrinsic Imaging completed the imaging charter in under three weeks, establishing the review framework while sites were still being activated. Electronic image submission with automated DICOM quality checks ensured that incoming studies were verified immediately upon receipt, and dedicated project management and adjudication teams maintained continuous momentum across all time zones. The operational model was deliberately scaled to the trial's geography, so that no site—however small its enrollment—waited on central review.

Results

• Initial image assessment completed within 48 hours of acquisition
• Database locked 10 days after last patient out
• Approval granted under Priority Review