Exceeding expectations for late-stage rescue study success

ICON stepped in when a biopharma company required urgent rescue assistance with two phase 3 trials for Hidradenitis Suppurativa (HS) and Psoriatic Arthritis (PsA) Unlike typical rescue studies where enrolment has slowed or stalled, these studies were in a later-stage at the time of transition, which effectively compressed the timelines and presented a unique challenge. ICON and sponsor teams had to rapidly prepare for data cuts while simultaneously transitioning the studies, managing startup processes and dealing with unknown events not previously identified by the outgoing CRO under tight timelines (for example, extensive unexpected SDV backlog and site payment concerns).

The rescue operation and transition timelines were condensed. The study transitions required additional coordination efforts and strategic agility given the challenge of a limited, three-week handoff period characterised by significant communication gaps from the outgoing CRO. Seamlessly transitioning rescue studies is challenging in itself. Combining this transition with two data cuts at an earlier stage than expected required significant effort from both ICON and the sponsor teams to ensure success. 

Moreover, ICON inherited outstanding site audit items from the outgoing CRO, which required additional time and resources to manage as the studies covered more than 190 sites across 10 countries. 

“We have seen changes in our submission strategy that had nothing to do with ICON. ICON has been helpful through this.”
– Sponsor testimonial

The sponsor’s experience with the outgoing CRO emphasised the importance of building trust between the ICON and sponsor teams to leverage the power of collaboration. ICON appointed two project managers that had previous rescue study experience to ensure the transitions went smoothly. They met regularly to share information and best practices to ensure continuity across the two studies for operational efficiency and data integrity. ICON and sponsor leadership met twice weekly to facilitate transparency and deeper collaboration, allowing for faster responses to challenges to meet the tight data cut deadlines. 

ICON took a more consultative approach to keep forward momentum on the studies and, when issues arose, the teams were able to communicate transparently and find the best solution. To meet the tight data cut deadlines, the teams prioritised tasks and allocated resources accordingly. As we onboarded the studies and the actual backlog became clear, resource allocation and CRA assignments were crucial components. The teams worked quickly with regional resourcing hubs to resolve headcount issues in some countries.

As part of the consultative dynamic vital to the success of these rescue studies, ICON provided additional TMF quality control support to build sponsor confidence. 

Both of ICON’s study teams successfully managed to transition clinical operations from the outgoing CRO within an accelerated 3-week period and prepared for important data cuts for each study all while performing the standard startup processes (plans, systems, resourcing, etc.).

As a result, both teams met their data cut deadlines, with primary endpoint read out for one study showing positive results. Importantly, ICON exceeded sponsor expectations, building a trusted, collaborative partnership amid these challenges.

“This [database lock] milestone is a testament to our great
teamwork, amazing effort, and unwavering dedication.”
– Sponsor testimonial