Case Study · Primary Biliary Cholangitis (Rare Disease)
How AcceleTrial helped a global biopharma company rapidly add specialist PBC sites to an ongoing study, clearing legal CDA cycles and compressed timelines through platform automation.
The Challenge
Adding sites to an ongoing rare disease study while navigating compressed timelines and legal CDA cycles required a platform capable of managing multiple parallel workflows without losing speed.
The sponsor needed 20 additional clinical sites for a Primary Biliary Cholangitis study. PBC is a rare disease with a limited pool of sites that have genuine hepatology expertise and the right patient population.
Legal CDA negotiation had to run in parallel with clinical feasibility outreach and document collection, all within a compressed rescue timeline.
As a rescue engagement, urgency was elevated. Sites needed to be activated efficiently and quickly. Any delay in identification or document execution had immediate impact on the study's enrollment trajectory.
The Solution
Using AcceleTrial, LINEA System identified 21 sites with specific hepatology trial expertise and the right PBC patient access profile. Turnaround for feasibility and CDAs was 2 to 3 days, exceeding the sponsor's expectations.
LINEA incorporated its internal CDA negotiation service to handle the legal cycle in parallel with clinical qualification. All study documents were collected at 50% the standard timeline. Sites were evaluated across trial history, COVID-readiness, debarment status, and clinical experience.
Outcomes
21 hepatology specialist sites identified against a target of 20, each qualified against protocol criteria for this rare PBC indication.
18 of LINEA's 21 sites received Protocol Site Visit approval, an 86% PSV approval rate from a rescue-context site pool.
Feasibility and CDAs completed in 2 to 3 days, including LINEA's internal CDA negotiation, exceeding sponsor expectations.
All necessary study documents collected at 50% the standard timeline, eliminating manual coordination delays.
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