Case Study | Primary Biliary Cholangitis (Rare Disease)
How AcceleTrial helped a global biopharma company add specialist PBC sites to an ongoing study in a compressed rescue timeline, including internal CDA negotiation support.
PBC limits the eligible site pool to those with genuine hepatology expertise and the right patient population.
CDA negotiation running in parallel with feasibility outreach and document collection under rescue urgency.
Every delay in identification or document execution had immediate impact on the ongoing study's enrollment trajectory.
Using AcceleTrial, LINEA identified 21 sites with hepatology expertise and PBC patient access. LINEA incorporated its internal CDA negotiation service to clear the legal cycle in parallel. Feasibility and CDAs were completed in 2 to 3 days. Documents were collected at 50% the standard rate.
Exceeded the rescue target of 20 additional sites in a rare disease indication.
18 of 21 LINEA sites received Protocol Site Visit approval, an 86% PSV rate.
Feasibility and CDAs including internal negotiation completed in 2 to 3 days.